Chronic Kidney DiseasesPhase 4NCT05942027
Role of Coenzyme Q10 in Chronic Kidney Disease
A Phase 4 study testing Co-Enzyme Q10 in people with Chronic Kidney Diseases, run by Tanta University at 1 site in Egypt.
Trial summary
This randomized placebo controlled double blind parallel clinical study will be conducted on 44 non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Co-Enzyme Q10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2023to 15 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Both sexes.
- Patients matched in the duration of CKD.
- Non-dialysis chronic kidney disease (CKD) patient with estimated glomerular filtration rate (GFR) 30-89 mL/min/1.73m2 (Stage 2-3b).
- Patients with albumin-to-creatinine ratio ≥ 30 mg/g.
- Patients with serum Potassium < 5 mEq/L.
- A newly diagnosed patients with hypertension.
Who cannot join
- Patients with elevated level of potassium ≥ 5 mEq/L.
- Patients with diabetes.
- Patients with cancer.
- Patients with heart disease.
- Patients with hepato-biliary disease and other liver diseases.
- Patients with kidney stones and urinary tract infection.
Show all 13Show fewer
- Patients with an overactive thyroid gland.
- Patients with bleeding disorder.
- History of drug allergy to ACEI or ARBs.
- Pregnant and breastfeeding women.
- Patients with blood pressure ≥180/110 or <100/60.
- Patients on alteplase, azothiopurine, everolimus, sirolimus, lithium, non-steroidal anti-inflammatory drugs (epifenac, tenoxicam, Celecoxib….), potassium retentive diuretics (amiloride, spironolactone), other ACEIs and ARBs will be excluded to avoid possible drug-drug interactions with ramipril.
- Patients on omega-3 fatty acids; vitamins (especially A, C, E, K), Chemotherapy and oral anticoagulant (warfarin), cholestyramine, orlistate will be excluded to avoid possible drug interactions that could affect Coenzyme Q10
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Pharmacy Tanta University
Tanta, Capital of Gharbia Governorate., 31527
Tarek Mostafa, Doctorate Degree, +2001154594035, tarek.mostafa@pharm.tanta.edu.eg
About this study
Official title: Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients With Chronic Kidney Disease
This randomized placebo controlled double blind parallel clinical study will be conducted on 44 non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients with Chronic Kidney Disease. Patients will be recruited from, Internal Medicine Department, Nephrology Unit, Alexandria Main University Hospital, Egypt. Patients with albumin-to-creatinine ratio ≥ 30 mg/g, with serum Potassium < 5 mEq/L and newly diagnosed patients with hypertension. The study duration will be 6 months. The patients will be randomized using stratified random block method into two groups.
Group 1: Control group Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b). Patients will be treated with ramipril 10 mg/day and a placebo match Coenzyme Q10 capsules once per day.The dose of ramipril may be modified according to blood pressure control.
Read more
Group 2: Coenzyme Q10 Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and Coenzyme Q10 capsules (CoQ10) 200 mg/day. The dose of ramipril may be modified according to blood pressure control.
Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.
Read the detailed description
Chronic kidney disease (CKD) is defined by a reduction in the kidney function (shown by reduced estimated glomerular filtration rate (eGFR) or markers of kidney damage, or both, for at least three months). It varies depending on the amount of blood pressure control, the degree of proteinuria, the previous rate of decline in GFR, and the underlying renal disease, including diabetes.
Phosphorus excretion decreases in many kidney disorders, and as a result, the amount of fibroblast growth factor 23 (FGF-23) rises.FGF-23 levels have appeared to predict risk of death in individuals with chronic renal disease as the estimated glomerular filtration rate declines, and a corresponding increase in FGF-23 can be noted.
FGF-23 is a hormone with a molecular weight of 30 kDa works on fibroblast growth factor receptors (FGFR1-4) in the kidney, heart, colon, and parathyroid gland. It is secreted by osteocytes and, to a lesser extent by osteoblasts into the bloodstream. A rise in FGF-23 could indicate kidney dysfunction, and concurrent bone disease. Patients with CKD are well known to have greater risk for developing bone fractures.
The term "chronic kidney disease-mineral bone disorder" (CKD-MBD) refers to the decline in bone quality and the subsequent development of disorders in bone and mineral metabolism caused by impaired kidney function. In addition to PTH, vitamin D, calcium and phosphorus, fibroblast growth factor-23 (FGF-23) play a role in CKD-MBD.
Treatment of the underlying disease, if possible, and treatment of secondary factors, such as increased blood pressure and proteinuria, are the two main ways to limit the rate of CKD progression. Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) are renin-angiotensin system (RAS) inhibitors that are more effective than other antihypertensive medications in reducing proteinuria and slowing the rate of progression of proteinuria during CKD, regardless of the etiology.
Ramipril inhibits ACE, which lowers FGF-23 expression in the kidney and attenuates proteinuria. Angiotensin inhibition frequently causes mild to moderate decrease in GFR and hyperkalemia following the treatment initiation or following dose escalation. If CKD is progressive, hyperkalemia may develop quickly after the start of treatment or at a later time.
Coenzyme Q10 (CoQ10) is an organic molecule can be found in both reduced (ubiquinol) and oxidised (ubiquinone) forms in mitochondria and cell membranes. Patients with CKD have been found to have considerably reduced plasma CoQ10 levels. CoQ10 lowers the level of aldosterone and modifies the angiotensin effect on sodium retention. An increase in CoQ10 availability may have altered renin-angiotensin-aldosterone action resulting in a decrease in ACE level. Additionally, the endothelium appears to be directly affected by CoQ10, causing vasodilation and reducing blood pressure. High dose CoQ10 supplementation in cases where the condition is treated early resulted in an improvement in renal function and a reduction in proteinuria.CoQ10 prevent an increase of FGF-23 and also provides a reduction in cardiovascular risk.The aim of this work is to evaluate the role of Coenzyme Q10 (CoQ10) as adjuvant therapy to angiotensin converting enzyme inhibitor on blood pressure, proteinuria and bone metabolism in patients with chronic kidney disease (CKD).
All the participants will be subjected to the following:
- Demography, History and Physical Examination
- Age, sex, sex distribution ratio (M/F) will be determined. Measurement of weight in nearest kilogram and height in nearest centimeter will be measured using Detecto Scale with subsequent calculation of body mass index according to the following formula: BMI= [Weight (kg) ÷ Height2 (m)]. Full medical history will be taken to avoid inclusion of any patient with confounding disease or medication in the study.
- Measurement of blood pressure will be done using a mercury sphygmomanometer in accordance with recommendations of the American Heart Association and standardized office blood pressure measurements. The mean values of the duplicate measurements will be recorded. The blood pressure will be assessed at baseline and every 4 weeks. Measurements of routine parameters at baseline, through evaluation of:
- Fasting blood glucose
- Alanine aminotransferase (ALT)
- Serum total bilirubin
- In addition, prothrombin time or international normalization ratio (INR) will be also assessed. Assessment of Proteinuria at the time of enrollment, 3 and 6 months after intervention. Proteinuria will be assessed using urine dipstick test. Albumin-to-creatinine ratio will be calculated by dividing the urinary albumin concentration by the urinary creatinine concentration. Assessment of kidney functions at baseline, 4 weeks, 3 and 6 months after initiation of ACEI by assessment: Serum creatinine, Estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021, blood urea nitrogen and serum potassium Evaluation of Chronic Kidney Disease-Mineral and Bone Disorder Chronic Kidney Disease-Mineral and Bone Disorder (CKD MBD) will be assessed at baseline and at the end of intervention through evaluation of: - Serum level of Fibroblast growth factor-23 (FGF-23)
- Serum Parathyroid hormone (PTH) level .
- Serum concentration of 25 (OH) vitamin D.
- Serum calcium
- Serum phosphorus
Clinical outcome will be assessed at baseline and 6 months after Intervention through:
- Evaluation of Health Related Quality of Life (HRQOL) using the validated Arabic version of -Kidney Disease and Quality of Life- Short Form (KDQOL-SF™) version 1.3 questionnaire which was formerly used in Egypt for patients with CKD.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Placebo, Co-Enzyme Q10
- Keywords
- Proteinuria, Bone Metabolism, Coenzyme Q10
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo match Coenzyme Q10 capsules once per day .
Co-Enzyme Q10Drug
Patients will be treated with Coenzyme Q10 capsules (CoQ10) 200 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Control group | Placebo comparator | Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b). Patients will be treated with ramipril 10 mg/day and a placebo match Coenzyme Q10 capsules once per day.The dose of ramipril may be modified according to blood pressure control.
Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months. Receives: Drug: Placebo |
| Group 2: Coenzyme Q10 | Active comparator | Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and Coenzyme Q10 capsules (CoQ10) 200 mg/day.The dose of ramipril may be modified according to blood pressure control.
Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months. Receives: Drug: Co-Enzyme Q10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in kidney function test measured by creatinine clearance (eGFR) mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021
Assessment of kidney functions at baseline, 4 weeks, 3 and 6 months after initiation of ACEI by assessment: Estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021.
Measured: The study duration will be 6 months.
The change in proteinuria level be assessed using Albumin-to-creatinine ratio (ACR) ratio (mg/g)
Assessment of Proteinuria at the time of enrollment, 3 and 6 months after intervention. Albumin-to-creatinine ratio will be calculated by dividing the urinary albumin concentration by the urinary creatinine concentration (mg/g)
Measured: The study duration will be 6 months
The change in blood pressure (mmHg) will be done using a mercury sphygmomanometer
Measurement of blood pressure will be done using a mercury sphygmomanometer in accordance with recommendations of the American Heart Association and standardized office blood pressure measurements. The mean values of the duplicate measurements will be recorded. The blood pressure will be assessed at baseline and every 4 weeks.
Measured: The study duration will be 6 months
The change in Blood urea nitrogen (BUN) (mg/dl)
Assessment of BUN (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
Measured: The study duration will be 6 months
The change in serum potassium (meq/l).
Assessment of serum potassium (meq/l) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
Measured: The study duration will be 6 months
The change in serum creatinine (mg/dl)
Assessment of serum creatinine (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
Measured: The study duration will be 6 months
The change in serum urea (mg/dl)
Assessment of serum urea (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
Measured: The study duration will be 6 months
Secondary outcomes (6)
The change in chronic kidney disease-mineral and bone disorder related parameters by assessment Serum level of Fibroblast growth factor-23 (FGF-23) (pg/ml)
Evaluation of Chronic Kidney Disease-Mineral and Bone Disorder Chronic Kidney Disease-Mineral and Bone Disorder (CKD MBD) will be assessed at baseline and at the end of intervention through evaluation of: - Serum level of Fibroblast growth factor-23 (FGF-23) (pg/ml)
Measured: The study duration will be 6 months.
The change in I-PTH (pg/ml)
The change in I-PTH (pg/ml) will be assessed at baseline and at the end of intervention through evaluation
Measured: The study duration will be 6 months
The change in vitamin D level (ng/ml)
The change in vitamin D level (ng/ml) will be assessed at baseline and at the end of intervention through evaluation
Measured: The study duration will be 6 months
The change in serum calcium level (mg/dl)
The change in serum calcium level (mg/dl) will be assessed at baseline and at the end of intervention through evaluation
Measured: The study duration will be 6 months
The change in serum phosphorus level (mg/dl)
The change in serum phosphorus level (mg/dl) will be assessed at baseline and at the end of intervention through evaluation
Measured: The study duration will be 6 months.
Clinical outcome will be assessed by Kidney Disease and Quality of Life- Short Form (KDQOL-SF™) version 1.3 questionnaire
Clinical outcome will be assessed at baseline and 6 months after Intervention through:
- Evaluation of Health Related Quality of Life (HRQOL) using the validated Arabic version of -Kidney Disease and Quality of Life- Short Form (KDQOL-SF™) version 1.3 questionnaire which was formerly used in Egypt for patients with CKD.
Measured: The study duration will be 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start15 Jul 2023
- Primary completion14 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Zaki Mohamed Zaki Abdel Hamid, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942027
- Sponsor's protocol ID
- Coenzyme Q10 in CKD
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
PubMed 32061315Levey AS, de Jong PE, Coresh J, El Nahas M, Astor BC, Matsushita K, Gansevoort RT, Kasiske BL, Eckardt KU. The definition, classification, and prognosis of chronic kidney disease: a KDIGO Controversies Conference report. Kidney Int. 2011 Jul;80(1):17-28. doi: 10.1038/ki.2010.483. Epub 2010 Dec 8.
PubMed 21150873Isakova T, Xie H, Yang W, Xie D, Anderson AH, Scialla J, Wahl P, Gutierrez OM, Steigerwalt S, He J, Schwartz S, Lo J, Ojo A, Sondheimer J, Hsu CY, Lash J, Leonard M, Kusek JW, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Fibroblast growth factor 23 and risks of mortality and end-stage renal disease in patients with chronic kidney disease. JAMA. 2011 Jun 15;305(23):2432-9. doi: 10.1001/jama.2011.826.
PubMed 21673295Shimada T, Hasegawa H, Yamazaki Y, Muto T, Hino R, Takeuchi Y, Fujita T, Nakahara K, Fukumoto S, Yamashita T. FGF-23 is a potent regulator of vitamin D metabolism and phosphate homeostasis. J Bone Miner Res. 2004 Mar;19(3):429-35. doi: 10.1359/JBMR.0301264. Epub 2003 Dec 29.
PubMed 15040831Sarafidis PA, Khosla N, Bakris GL. Antihypertensive therapy in the presence of proteinuria. Am J Kidney Dis. 2007 Jan;49(1):12-26. doi: 10.1053/j.ajkd.2006.10.014.
PubMed 17185142Yeung CK, Billings FT 4th, Claessens AJ, Roshanravan B, Linke L, Sundell MB, Ahmad S, Shao B, Shen DD, Ikizler TA, Himmelfarb J. Coenzyme Q10 dose-escalation study in hemodialysis patients: safety, tolerability, and effect on oxidative stress. BMC Nephrol. 2015 Nov 3;16:183. doi: 10.1186/s12882-015-0178-2.
PubMed 26531095FABRE LF Jr, BANKS RC, MCISAAC WM, FARRELL G. EFFECTS OF UBIQUINONE AND RELATED SUBSTANCES ON SECRETION OF ALDOSTERONE AND CORTISOL. Am J Physiol. 1965 Jun;208:1275-80. doi: 10.1152/ajplegacy.1965.208.6.1275. No abstract available.
PubMed 14301392Heeringa SF, Chernin G, Chaki M, Zhou W, Sloan AJ, Ji Z, Xie LX, Salviati L, Hurd TW, Vega-Warner V, Killen PD, Raphael Y, Ashraf S, Ovunc B, Schoeb DS, McLaughlin HM, Airik R, Vlangos CN, Gbadegesin R, Hinkes B, Saisawat P, Trevisson E, Doimo M, Casarin A, Pertegato V, Giorgi G, Prokisch H, Rotig A, Nurnberg G, Becker C, Wang S, Ozaltin F, Topaloglu R, Bakkaloglu A, Bakkaloglu SA, Muller D, Beissert A, Mir S, Berdeli A, Varpizen S, Zenker M, Matejas V, Santos-Ocana C, Navas P, Kusakabe T, Kispert A, Akman S, Soliman NA, Krick S, Mundel P, Reiser J, Nurnberg P, Clarke CF, Wiggins RC, Faul C, Hildebrandt F. COQ6 mutations in human patients produce nephrotic syndrome with sensorineural deafness. J Clin Invest. 2011 May;121(5):2013-24. doi: 10.1172/JCI45693. Epub 2011 Apr 11.
PubMed 21540551Alehagen U, Aaseth J, Larsson A, Alexander J. Decreased Concentration of Fibroblast Growth Factor 23 (FGF-23) as a Result of Supplementation with Selenium and Coenzyme Q10 in an Elderly Swedish Population: A Sub-Analysis. Cells. 2022 Feb 1;11(3):509. doi: 10.3390/cells11030509.
PubMed 35159318
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05942027
- Acronym / sponsor ID
- Coenzyme Q10 in CKD
- Conditions
- Chronic Kidney Diseases
- Keywords
- Proteinuria, Bone Metabolism, Coenzyme Q10
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 14 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized placebo controlled double blind parallel clinical study will be conducted on 44 non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Clinical Study Evaluating the Role of Coenzyme Q10 as Adjuvant Therapy to Angiotensin Converting Enzyme Inhibitor on Blood Pressure, Proteinuria and Bone Metabolism in Patients with Chronic Kidney Disease. Patients will be recruited from, Internal Medicine Department, Nephrology Unit, Alexandria Main University Hospital, Egypt. Patients with albumin-to-creatinine ratio ≥ 30 mg/g, with serum Potassium < 5 mEq/L and newly diagnosed patients with hypertension. The study duration will be 6 months. The patients will be randomized using stratified random block method into two groups.
Group 1: Control group Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b). Patients will be treated with ramipril 10 mg/day and a placebo match Coenzyme Q10 capsules once per day.The dose of ramipril may be modified according to blood pressure control.
Group 2: Coenzyme Q10 Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and Coenzyme Q10 capsules (CoQ10) 200 mg/day. The dose of ramipril may be modified according to blood pressure control.
Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months.
Detailed description
Chronic kidney disease (CKD) is defined by a reduction in the kidney function (shown by reduced estimated glomerular filtration rate (eGFR) or markers of kidney damage, or both, for at least three months). It varies depending on the amount of blood pressure control, the degree of proteinuria, the previous rate of decline in GFR, and the underlying renal disease, including diabetes.
Phosphorus excretion decreases in many kidney disorders, and as a result, the amount of fibroblast growth factor 23 (FGF-23) rises.FGF-23 levels have appeared to predict risk of death in individuals with chronic renal disease as the estimated glomerular filtration rate declines, and a corresponding increase in FGF-23 can be noted.
FGF-23 is a hormone with a molecular weight of 30 kDa works on fibroblast growth factor receptors (FGFR1-4) in the kidney, heart, colon, and parathyroid gland. It is secreted by osteocytes and, to a lesser extent by osteoblasts into the bloodstream. A rise in FGF-23 could indicate kidney dysfunction, and concurrent bone disease. Patients with CKD are well known to have greater risk for developing bone fractures.
The term "chronic kidney disease-mineral bone disorder" (CKD-MBD) refers to the decline in bone quality and the subsequent development of disorders in bone and mineral metabolism caused by impaired kidney function. In addition to PTH, vitamin D, calcium and phosphorus, fibroblast growth factor-23 (FGF-23) play a role in CKD-MBD.
Treatment of the underlying disease, if possible, and treatment of secondary factors, such as increased blood pressure and proteinuria, are the two main ways to limit the rate of CKD progression. Angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) are renin-angiotensin system (RAS) inhibitors that are more effective than other antihypertensive medications in reducing proteinuria and slowing the rate of progression of proteinuria during CKD, regardless of the etiology.
Ramipril inhibits ACE, which lowers FGF-23 expression in the kidney and attenuates proteinuria. Angiotensin inhibition frequently causes mild to moderate decrease in GFR and hyperkalemia following the treatment initiation or following dose escalation. If CKD is progressive, hyperkalemia may develop quickly after the start of treatment or at a later time.
Coenzyme Q10 (CoQ10) is an organic molecule can be found in both reduced (ubiquinol) and oxidised (ubiquinone) forms in mitochondria and cell membranes. Patients with CKD have been found to have considerably reduced plasma CoQ10 levels. CoQ10 lowers the level of aldosterone and modifies the angiotensin effect on sodium retention. An increase in CoQ10 availability may have altered renin-angiotensin-aldosterone action resulting in a decrease in ACE level. Additionally, the endothelium appears to be directly affected by CoQ10, causing vasodilation and reducing blood pressure. High dose CoQ10 supplementation in cases where the condition is treated early resulted in an improvement in renal function and a reduction in proteinuria.CoQ10 prevent an increase of FGF-23 and also provides a reduction in cardiovascular risk.The aim of this work is to evaluate the role of Coenzyme Q10 (CoQ10) as adjuvant therapy to angiotensin converting enzyme inhibitor on blood pressure, proteinuria and bone metabolism in patients with chronic kidney disease (CKD).
All the participants will be subjected to the following:
- Demography, History and Physical Examination
- Age, sex, sex distribution ratio (M/F) will be determined. Measurement of weight in nearest kilogram and height in nearest centimeter will be measured using Detecto Scale with subsequent calculation of body mass index according to the following formula: BMI= [Weight (kg) ÷ Height2 (m)]. Full medical history will be taken to avoid inclusion of any patient with confounding disease or medication in the study.
- Measurement of blood pressure will be done using a mercury sphygmomanometer in accordance with recommendations of the American Heart Association and standardized office blood pressure measurements. The mean values of the duplicate measurements will be recorded. The blood pressure will be assessed at baseline and every 4 weeks. Measurements of routine parameters at baseline, through evaluation of:
- Fasting blood glucose
- Alanine aminotransferase (ALT)
- Serum total bilirubin
- In addition, prothrombin time or international normalization ratio (INR) will be also assessed. Assessment of Proteinuria at the time of enrollment, 3 and 6 months after intervention. Proteinuria will be assessed using urine dipstick test. Albumin-to-creatinine ratio will be calculated by dividing the urinary albumin concentration by the urinary creatinine concentration. Assessment of kidney functions at baseline, 4 weeks, 3 and 6 months after initiation of ACEI by assessment: Serum creatinine, Estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021, blood urea nitrogen and serum potassium Evaluation of Chronic Kidney Disease-Mineral and Bone Disorder Chronic Kidney Disease-Mineral and Bone Disorder (CKD MBD) will be assessed at baseline and at the end of intervention through evaluation of: - Serum level of Fibroblast growth factor-23 (FGF-23)
- Serum Parathyroid hormone (PTH) level .
- Serum concentration of 25 (OH) vitamin D.
- Serum calcium
- Serum phosphorus
Clinical outcome will be assessed at baseline and 6 months after Intervention through:
- Evaluation of Health Related Quality of Life (HRQOL) using the validated Arabic version of -Kidney Disease and Quality of Life- Short Form (KDQOL-SF™) version 1.3 questionnaire which was formerly used in Egypt for patients with CKD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Control group | Placebo comparator | Drug: PlaceboNon-dialysis chronic kidney disease (CKD) patients (Stages 2-3b). Patients will be treated with ramipril 10 mg/day and a placebo match Coenzyme Q10 capsules once per day.The dose of ramipril may be modified according to blood pressure control. Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months. |
| Group 2: Coenzyme Q10 | Active comparator | Drug: Co-Enzyme Q10Non-dialysis chronic kidney disease (CKD) patients (Stages 2-3b).Patients will be treated with ramipril 10 mg/day and Coenzyme Q10 capsules (CoQ10) 200 mg/day.The dose of ramipril may be modified according to blood pressure control. Participants will be followed-up by weekly telephone calls and monthly direct meetings to assess their adherence for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old.
- Both sexes.
- Patients matched in the duration of CKD.
- Non-dialysis chronic kidney disease (CKD) patient with estimated glomerular filtration rate (GFR) 30-89 mL/min/1.73m2 (Stage 2-3b).
- Patients with albumin-to-creatinine ratio ≥ 30 mg/g.
Key exclusion criteria (13 listed)
- Patients with elevated level of potassium ≥ 5 mEq/L.
- Patients with diabetes.
- Patients with cancer.
- Patients with heart disease.
- Patients with hepato-biliary disease and other liver diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo match Coenzyme Q10 capsules once per day . | Drug | Group 1: Control group |
| Co-Enzyme Q10Patients will be treated with Coenzyme Q10 capsules (CoQ10) 200 mg/day. | Drug | Group 2: Coenzyme Q10 |
Primary outcome
The change in kidney function test measured by creatinine clearance (eGFR) mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021
Time frame: The study duration will be 6 months.
Assessment of kidney functions at baseline, 4 weeks, 3 and 6 months after initiation of ACEI by assessment: Estimated glomerular filtration rate (eGFR) in mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021.
The change in proteinuria level be assessed using Albumin-to-creatinine ratio (ACR) ratio (mg/g)
Time frame: The study duration will be 6 months
Assessment of Proteinuria at the time of enrollment, 3 and 6 months after intervention. Albumin-to-creatinine ratio will be calculated by dividing the urinary albumin concentration by the urinary creatinine concentration (mg/g)
The change in blood pressure (mmHg) will be done using a mercury sphygmomanometer
Time frame: The study duration will be 6 months
Measurement of blood pressure will be done using a mercury sphygmomanometer in accordance with recommendations of the American Heart Association and standardized office blood pressure measurements. The mean values of the duplicate measurements will be recorded. The blood pressure will be assessed at baseline and every 4 weeks.
The change in Blood urea nitrogen (BUN) (mg/dl)
Time frame: The study duration will be 6 months
Assessment of BUN (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
The change in serum potassium (meq/l).
Time frame: The study duration will be 6 months
Assessment of serum potassium (meq/l) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
The change in serum creatinine (mg/dl)
Time frame: The study duration will be 6 months
Assessment of serum creatinine (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
The change in serum urea (mg/dl)
Time frame: The study duration will be 6 months
Assessment of serum urea (mg/dl) at baseline, 4 weeks, 3 and 6 months after initiation of ACEI
6 secondary outcomes
The change in chronic kidney disease-mineral and bone disorder related parameters by assessment Serum level of Fibroblast growth factor-23 (FGF-23) (pg/ml)
Time frame: The study duration will be 6 months.
The change in I-PTH (pg/ml)
Time frame: The study duration will be 6 months
The change in vitamin D level (ng/ml)
Time frame: The study duration will be 6 months
The change in serum calcium level (mg/dl)
Time frame: The study duration will be 6 months
The change in serum phosphorus level (mg/dl)
Time frame: The study duration will be 6 months.
Clinical outcome will be assessed by Kidney Disease and Quality of Life- Short Form (KDQOL-SF™) version 1.3 questionnaire
Time frame: The study duration will be 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Background: PubMed 32061315GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
- Background: PubMed 21150873Levey AS, de Jong PE, Coresh J, El Nahas M, Astor BC, Matsushita K, Gansevoort RT, Kasiske BL, Eckardt KU. The definition, classification, and prognosis of chronic kidney disease: a KDIGO Controversies Conference report. Kidney Int. 2011 Jul;80(1):17-28. doi: 10.1038/ki.2010.483. Epub 2010 Dec 8.
- Background: PubMed 21673295Isakova T, Xie H, Yang W, Xie D, Anderson AH, Scialla J, Wahl P, Gutierrez OM, Steigerwalt S, He J, Schwartz S, Lo J, Ojo A, Sondheimer J, Hsu CY, Lash J, Leonard M, Kusek JW, Feldman HI, Wolf M; Chronic Renal Insufficiency Cohort (CRIC) Study Group. Fibroblast growth factor 23 and risks of mortality and end-stage renal disease in patients with chronic kidney disease. JAMA. 2011 Jun 15;305(23):2432-9. doi: 10.1001/jama.2011.826.
- Background: PubMed 15040831Shimada T, Hasegawa H, Yamazaki Y, Muto T, Hino R, Takeuchi Y, Fujita T, Nakahara K, Fukumoto S, Yamashita T. FGF-23 is a potent regulator of vitamin D metabolism and phosphate homeostasis. J Bone Miner Res. 2004 Mar;19(3):429-35. doi: 10.1359/JBMR.0301264. Epub 2003 Dec 29.
- Background: PubMed 17185142Sarafidis PA, Khosla N, Bakris GL. Antihypertensive therapy in the presence of proteinuria. Am J Kidney Dis. 2007 Jan;49(1):12-26. doi: 10.1053/j.ajkd.2006.10.014.
- Background: PubMed 26531095Yeung CK, Billings FT 4th, Claessens AJ, Roshanravan B, Linke L, Sundell MB, Ahmad S, Shao B, Shen DD, Ikizler TA, Himmelfarb J. Coenzyme Q10 dose-escalation study in hemodialysis patients: safety, tolerability, and effect on oxidative stress. BMC Nephrol. 2015 Nov 3;16:183. doi: 10.1186/s12882-015-0178-2.
- Background: PubMed 14301392FABRE LF Jr, BANKS RC, MCISAAC WM, FARRELL G. EFFECTS OF UBIQUINONE AND RELATED SUBSTANCES ON SECRETION OF ALDOSTERONE AND CORTISOL. Am J Physiol. 1965 Jun;208:1275-80. doi: 10.1152/ajplegacy.1965.208.6.1275. No abstract available.
- Background: PubMed 21540551Heeringa SF, Chernin G, Chaki M, Zhou W, Sloan AJ, Ji Z, Xie LX, Salviati L, Hurd TW, Vega-Warner V, Killen PD, Raphael Y, Ashraf S, Ovunc B, Schoeb DS, McLaughlin HM, Airik R, Vlangos CN, Gbadegesin R, Hinkes B, Saisawat P, Trevisson E, Doimo M, Casarin A, Pertegato V, Giorgi G, Prokisch H, Rotig A, Nurnberg G, Becker C, Wang S, Ozaltin F, Topaloglu R, Bakkaloglu A, Bakkaloglu SA, Muller D, Beissert A, Mir S, Berdeli A, Varpizen S, Zenker M, Matejas V, Santos-Ocana C, Navas P, Kusakabe T, Kispert A, Akman S, Soliman NA, Krick S, Mundel P, Reiser J, Nurnberg P, Clarke CF, Wiggins RC, Faul C, Hildebrandt F. COQ6 mutations in human patients produce nephrotic syndrome with sensorineural deafness. J Clin Invest. 2011 May;121(5):2013-24. doi: 10.1172/JCI45693. Epub 2011 Apr 11.
- Background: PubMed 35159318Alehagen U, Aaseth J, Larsson A, Alexander J. Decreased Concentration of Fibroblast Growth Factor 23 (FGF-23) as a Result of Supplementation with Selenium and Coenzyme Q10 in an Elderly Swedish Population: A Sub-Analysis. Cells. 2022 Feb 1;11(3):509. doi: 10.3390/cells11030509.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Co-Enzyme Q10 in people with Chronic Kidney Diseases, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Abdel Hamid, Masters (+2001020198970, pg_87899@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in kidney function test measured by creatinine clearance (eGFR) mL/min/1.73m2 which will be calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation, 2021 (time frame: The study duration will be 6 months.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05942027, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.