Chronic Kidney DiseasesNCT04939870
Assessment of Protein Modification in Chronic Kidney Disease - Selected Clinical and Biochemical Aspects
An observational study of Chronic Kidney Diseases and Cardiovascular Diseases, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
The studies included the effect of chronic kidney disease advancement on the accumulation of oxidative stress markers in plasma. In patients with end-stage renal disease, the effect of replacement therapy was also assessed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Cardiovascular Diseases, Dialysis; Complications
- What is being tested?
- Biochemical parameters evaluation
- How many people
- 195 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2015to 10 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study involved 195 people, including 126 patients with diagnosed CKD, under the care of the Nephrology Outpatient Clinic, Peritoneal Dialysis Clinic or the Dialysis Center at the Clinical Hospital. H. Święcicki in Poznań (group from CKD) and 69 people who constituted the control group. Recruitment to the study lasted one year. In the group of patients with CKD, depending on the degree of renal impairment and the type of renal replacement therapy, according to the criteria of diagnosis and classification of CKD according to KDIGO 2012, several subgroups were created. The allocation to groups was based on the GFR, calculated by the recommendations of KDIGO 2012
The following criteria of qualifying for the study were adopted for all respondents:
- 18 years of age or older,
- written consent to participate in the study,
- no smoking for at least 10 years in the history of
- no alcohol abuse for at least 10 years in a medical history,
- lack of diabetes and impaired fasting glucose and/or impaired glucose tolerance,
- no active inflammatory process,
- no neoplastic disease or a neoplastic disease whose treatment was stopped at least 10 years ago,
- no history of immunosuppressive treatment,
- stable liver function (not more than two times increased activity of transaminases), HBs antigen and anti-HCV negative antibodies,
- anti-HIV negative antibodies.
In addition, for CKD patients, the following additional inclusion conditions were applied:
- no additional comorbidities that do not result directly or indirectly from CKD,
- no acute cardiovascular complications, ie acute heart failure, hypertensive crisis, acute coronary syndrome, at the time of study entry.
At the same time, depending on the technique of renal replacement therapy used, additional inclusion criteria were established for each of the subgroups:
in group HD:
- a minimum of 6 months of treatment with repeated hemodialysis, 3 times a week, for a minimum of 10 hours a week,
- arteriovenous fistula as a vascular access for hemodialysis,
- Estimated dialysis adequacy ratio (eKt / V) of at least 1.2. in the PD group:
- treatment duration UP to a minimum of 6 months,
- Kt / V ≥1.8 l / week / 1.73 m2.
For CARD patients, additional conditions include:
- no obvious evidence of renal impairment in the history and at the time of study entry, renal function assessed on the basis of eGFR and urine albumin/creatinine ratio,
- history of angina,
- documented history of at least one acute coronary syndrome,
- admission to the Department of Intensive Care of Cardiology and Internal Diseases in order to perform a planned coronary angiography,
- on the day of admission to the study without signs of acute coronary syndrome,
- no additional comorbidities, ie those that do not result directly or indirectly from coronary heart disease.
In turn, for the HV group, additional conditions include:
- no obvious evidence of renal impairment in the history and at the time of study entry, renal function assessed on the basis of eGFR and urine albumin/creatinine ratio,
- no obvious signs of cardiovascular impairment in the history and at the time of study entry, estimated on the basis of normal blood pressure (<140/90 mmHg), no abnormalities in the medical history and physical examination,
- not taking any medications on a regular basis.
Trial locations and contacts
1 site in 1 country.
About this study
The studies included the effect of chronic kidney disease advancement on the accumulation of oxidative stress markers in plasma. In patients with end-stage renal disease, the effect of replacement therapy was also assessed. Therefore, the patient with chronic kidney disease was evaluated divided into three groups (chronic kidney disease at stage G3b-G4, peritoneal dialysis, hemodialysis). In addition, changes in the interrelationship between oxidative modifications, carbonyl and nitrogen stress, and the carbamylation resulting from the progression of kidney disease have been taken into account. This issue is related to the assessment of whether the protein modification types differentiate patients depending on the stage of chronic kidney disease and the method of renal replacement therapy. Protein modifications associated with oxidative stress are a part of the complications resulting from chronic kidney diseases, such as malnutrition, chronic inflammation, dyslipidemia, iron disorder, and calcium and phosphate disorders. Also, diseases of atherosclerosis aetiology are much higher frequency in patients with chronic kidney disease than in those with normal kidney function. Therefore, in the studies presented here, particular attention was paid to the effect of oxidative stress on chronic kidney disease complications in the aspect of cardiovascular damage. The specificity of atherosclerosis in patients with chronic kidney disease was evaluated by comparing groups of this type of patients with patients with ischemic heart diseases and normal renal function.
Read the detailed description
Redox imbalance in the course of CKD results in the intensification of oxidative and carbonyl stress, which leads to the modification of many molecules, including proteins necessary for the proper functioning of the body. The assessment of the accumulation of modified proteins in the plasma is not only an indirect indicator of the severity of redox imbalance in the system, but also allows the analysis of the influence of oxidative stress and its derivatives (glycation, carbonyl stress and carbamylation) on the pathogenesis of CKD. In addition, compounds formed as a result of the action of ROS on proteins may affect the development of long-term consequences of CKD, such as chronic inflammation, dyslipidemia, renal osteodystrophy, iron metabolism disorders and malnutrition. On the other hand, complications in patients with CKD may influence the intensification of oxidative modifications of proteins.
The following goals were set in the study:
- Assessment of the impact of CKD advancement on the severity of protein modification as a result of oxidative stress.
- Comparison of the effect of renal replacement therapy on protein modifications.
- Assessment of the relationship between selected protein modifications in CKD and complications typical of CKD
- Comparison of selected protein modifications in patients with CKD and patients with at least one history of a cardiovascular event.
- Being tested
- Biochemical parameters evaluation
- Keywords
- oxidative stress, proteins, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical parameters evaluationDiagnostic test
selected biochemical parameters
| Study group | Role | What they receive |
|---|---|---|
| PREDIALYSIS GROUP | (n = 48) - patients in the pre-dialysis period (stage G3b-G4 CKD) with moderate or severe decrease in eGFR (eGFR 44-29 ml / min / 1.73 m2), Receives: Diagnostic Test: Biochemical parameters evaluation | |
| END-STAGE RENAL DISEASE GROUP | patients with ESRD (n=78) - (eGFR <15 ml/min /1.73 m2) undergoing renal replacement therapy. Depending on the method of renal replacement therapy used, two subgroups are distinguished: PD subgroup (n=35) including patients treated by peritoneal dialysis. In this subgroup, initially, due to the treatment technique, two groups were separated, a group (n=15) treated with the automatic peritoneal dialysis (APD) technique, and a group of patients (n = 20) using the technique of continuous cycling peritoneal dialysis (CCPD), HD subgroup (n = 43) including patients treated with repeated hemodialysis. Hemodialysis procedures were performed in each patient three times a week, via an arteriovenous fistula from own or artificial vessels. The duration of hemodialysis was at least 10 hours/week using standard bicarbonate dialysis fluids and polysulfone low-flux dialyzers. The blood flow during hemodialysis was 200-350 ml/min, with an average dialysis fluid flow of 500 ml/min. Receives: Diagnostic Test: Biochemical parameters evaluation | |
| CARDIOLOGY GROUP | • CARD group (n = 37) - patients with at least one history of cardiovascular events, admitted to hospital for elective angiography, without any signs of impaired kidney function. The studies in this group were to show the changes that occur as a result of diseases of the cardiovascular system and the functioning of the kidneys. Receives: Diagnostic Test: Biochemical parameters evaluation | |
| HEALTHY VOLUNTEERS | Healthy volunteers, (n = 32) - it was composed of healthy people, with no evidence of impairment in renal function and cardiovascular function in the history and at the time of enrollment in the study. Receives: Diagnostic Test: Biochemical parameters evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical parameters assessed in all groups part 1
The number of laboratory parameters were determined in all groups:
- blood count: HGB [g/dl], RBC [10*12/l], HCT [l/l], WBC [10*9/l], PLT [10*9/l]
- iron metabolism parameters: Fe, UIBC,TIBC [µg/dl], ferritin [ng/ml]
- glucose [mg/dl]
- parameters of lipid metabolism [mg/dl] T-C, LDL-C, HDL-C, TG
- parameters of hepatic metabolism [U/l]: activity of alanine transaminase, aspartate transaminase, alkaline phosphatase
- creatinine [mg/dl], uric acid [mg/dl], urea [mg/dl],
- creatinine will be combined with sex [female/male] and age [years] to report eGFR [ml/min/1,73m*2] calculated on the basis on MDRD formula
- albumin [g/dl] and total protein [g/dl]
- Na [mmol/l], K [mmol/l]
- parameters of calcium and phosphate metabolism: total calcium [mg/dl], ionised calcium [mg/dl], phosphates [mg/dl], PTH [pg/ml], FGF-23 [pg/ml], klotho [ng/ml]
- selected parameters of inflammation: concentration of highly sensitive C-reactive protein (hsCRP) [mg/l]
Measured: 4 years
Biochemical parameters assessed in all groups part 2 - selected parameters of oxidative stress
CML [µg/mg protein], CEL [µg/mg protein], MG [µg/mg protein], AGE [µg/mg protein], RAGE [µg/mg protein] 3-NT [µmol/mg protein], AOPP [µmol/mg protein], carbonyl protein groups [nmol/mg protein], carbamyl protein groups [µg/mg protein]
Measured: 4 years
Demographic data
age [years], sex [number of female and male [n]] were recorded in all groups
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Jan 2015
- Primary completion31 Dec 2018
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorota Formanowicz, Poznan University of Medical Sciences
- Investigators
- Dorota Formanowicz, MD,PhD,Prof, Principal investigator, Poznan University of Mediccal Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939870
- Sponsor's protocol ID
- PoznanUMS_DF_1
- Status last verified
- Dec 2021
- First submitted
- 17 Jun 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Protein Modification in Chronic Kidney Disease - Selected Clinical and Biochemical Aspects
- ClinicalTrials.gov ID
- NCT04939870
- Acronym / sponsor ID
- PoznanUMS_DF_1
- Keywords
- oxidative stress, proteins, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 25 Jun 2021 (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.
The studies included the effect of chronic kidney disease advancement on the accumulation of oxidative stress markers in plasma. In patients with end-stage renal disease, the effect of replacement therapy was also assessed. Therefore, the patient with chronic kidney disease was evaluated divided into three groups (chronic kidney disease at stage G3b-G4, peritoneal dialysis, hemodialysis). In addition, changes in the interrelationship between oxidative modifications, carbonyl and nitrogen stress, and the carbamylation resulting from the progression of kidney disease have been taken into account. This issue is related to the assessment of whether the protein modification types differentiate patients depending on the stage of chronic kidney disease and the method of renal replacement therapy. Protein modifications associated with oxidative stress are a part of the complications resulting from chronic kidney diseases, such as malnutrition, chronic inflammation, dyslipidemia, iron disorder, and calcium and phosphate disorders. Also, diseases of atherosclerosis aetiology are much higher frequency in patients with chronic kidney disease than in those with normal kidney function. Therefore, in the studies presented here, particular attention was paid to the effect of oxidative stress on chronic kidney disease complications in the aspect of cardiovascular damage. The specificity of atherosclerosis in patients with chronic kidney disease was evaluated by comparing groups of this type of patients with patients with ischemic heart diseases and normal renal function.
Detailed description
Redox imbalance in the course of CKD results in the intensification of oxidative and carbonyl stress, which leads to the modification of many molecules, including proteins necessary for the proper functioning of the body. The assessment of the accumulation of modified proteins in the plasma is not only an indirect indicator of the severity of redox imbalance in the system, but also allows the analysis of the influence of oxidative stress and its derivatives (glycation, carbonyl stress and carbamylation) on the pathogenesis of CKD. In addition, compounds formed as a result of the action of ROS on proteins may affect the development of long-term consequences of CKD, such as chronic inflammation, dyslipidemia, renal osteodystrophy, iron metabolism disorders and malnutrition. On the other hand, complications in patients with CKD may influence the intensification of oxidative modifications of proteins.
The following goals were set in the study:
- Assessment of the impact of CKD advancement on the severity of protein modification as a result of oxidative stress.
- Comparison of the effect of renal replacement therapy on protein modifications.
- Assessment of the relationship between selected protein modifications in CKD and complications typical of CKD
- Comparison of selected protein modifications in patients with CKD and patients with at least one history of a cardiovascular event.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PREDIALYSIS GROUP | – | Diagnostic Test: Biochemical parameters evaluation(n = 48) - patients in the pre-dialysis period (stage G3b-G4 CKD) with moderate or severe decrease in eGFR (eGFR 44-29 ml / min / 1.73 m2), |
| END-STAGE RENAL DISEASE GROUP | – | Diagnostic Test: Biochemical parameters evaluationpatients with ESRD (n=78) - (eGFR <15 ml/min /1.73 m2) undergoing renal replacement therapy. Depending on the method of renal replacement therapy used, two subgroups are distinguished: PD subgroup (n=35) including patients treated by peritoneal dialysis. In this subgroup, initially, due to the treatment technique, two groups were separated, a group (n=15) treated with the automatic peritoneal dialysis (APD) technique, and a group of patients (n = 20) using the technique of continuous cycling peritoneal dialysis (CCPD), HD subgroup (n = 43) including patients treated with repeated hemodialysis. Hemodialysis procedures were performed in each patient three times a week, via an arteriovenous fistula from own or artificial vessels. The duration of hemodialysis was at least 10 hours/week using standard bicarbonate dialysis fluids and polysulfone low-flux dialyzers. The blood flow during hemodialysis was 200-350 ml/min, with an average dialysis fluid flow of 500 ml/min. |
| CARDIOLOGY GROUP | – | Diagnostic Test: Biochemical parameters evaluation• CARD group (n = 37) - patients with at least one history of cardiovascular events, admitted to hospital for elective angiography, without any signs of impaired kidney function. The studies in this group were to show the changes that occur as a result of diseases of the cardiovascular system and the functioning of the kidneys. |
| HEALTHY VOLUNTEERS | – | Diagnostic Test: Biochemical parameters evaluationHealthy volunteers, (n = 32) - it was composed of healthy people, with no evidence of impairment in renal function and cardiovascular function in the history and at the time of enrollment in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study involved 195 people, including 126 patients with diagnosed CKD, under the care of the Nephrology Outpatient Clinic, Peritoneal Dialysis Clinic or the Dialysis Center at the Clinical Hospital. H. Święcicki in Poznań (group from CKD) and 69 people who constituted the control group. Recruitment to the study lasted one year. In the group of patients with CKD, depending on the degree of renal impairment and the type of renal replacement therapy, according to the criteria of diagnosis and classification of CKD according to KDIGO 2012, several subgroups were created. The allocation to groups was based on the GFR, calculated by the recommendations of KDIGO 2012
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 |
|---|---|---|
| Biochemical parameters evaluationselected biochemical parameters | Diagnostic test | CARDIOLOGY GROUP, END-STAGE RENAL DISEASE GROUP, HEALTHY VOLUNTEERS, PREDIALYSIS GROUP |
Primary outcome
Biochemical parameters assessed in all groups part 1
Time frame: 4 years
The number of laboratory parameters were determined in all groups: * blood count: HGB [g/dl], RBC [10*12/l], HCT [l/l], WBC [10*9/l], PLT [10*9/l] * iron metabolism parameters: Fe, UIBC,TIBC [µg/dl], ferritin [ng/ml] * glucose [mg/dl] * parameters of lipid metabolism [mg/dl] T-C, LDL-C, HDL-C, TG * parameters of hepatic metabolism [U/l]: activity of alanine transaminase, aspartate transaminase, alkaline phosphatase * creatinine [mg/dl], uric acid [mg/dl], urea [mg/dl], * creatinine will be combined with sex [female/male] and age [years] to report eGFR [ml/min/1,73m*2] calculated on the basis on MDRD formula * albumin [g/dl] and total protein [g/dl] * Na [mmol/l], K [mmol/l] * parameters of calcium and phosphate metabolism: total calcium [mg/dl], ionised calcium [mg/dl], phosphates [mg/dl], PTH [pg/ml], FGF-23 [pg/ml], klotho [ng/ml] * selected parameters of inflammation: concentration of highly sensitive C-reactive protein (hsCRP) [mg/l]
Biochemical parameters assessed in all groups part 2 - selected parameters of oxidative stress
Time frame: 4 years
CML [µg/mg protein], CEL [µg/mg protein], MG [µg/mg protein], AGE [µg/mg protein], RAGE [µg/mg protein] 3-NT [µmol/mg protein], AOPP [µmol/mg protein], carbonyl protein groups [nmol/mg protein], carbamyl protein groups [µg/mg protein]
Demographic data
Time frame: 4 years
age [years], sex [number of female and male [n]] were recorded in all groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dorota Formanowicz, MD,PhD,Prof principal investigator
Poznan University of Mediccal Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Cardiovascular Diseases, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 10 Dec 2021. 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 Poland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical parameters assessed in all groups part 1 (time frame: 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2021.