ESRD (End Stage Renal Disease)NCT07109778
Copper to Zinc Ratio in End Stage Renal Disease Patients Outcome
An observational study of ESRD (End Stage Renal Disease) and Control Condition, run by Minia University at 1 site in Egypt.
Trial summary
The goal of this observational clinical trial is to Study the impact of copper to zinc ratio on the outcome of ESRD patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ESRD (End Stage Renal Disease), Control Condition
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Apr 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: this prospective observational Case control study will enroll a well-characterized cohort of 100 adult patients with ESRD(eGFR <15 mL/min/1.73 m²) , including those undergoing maintenance hemodialysis recruited from nephrology clinics and dialysis unit at Minia University Hospital . The recruited patients will be stratified into two groups; 1. Dialysis ESRD Group: It will include 100 adult patients with ESRD stage 5D on maintenance hemodialysis for at least 6 months. 2. control groub study the impact of Cu/Zn ratio on outcomme of ESRD patients
Who may be able to join
- ESRD patients including those on maintenance HD
Who cannot join
- Acute kidney injury or rapidly progressive glomerulonephritis, acute infections or active inflammatory conditions as sepsis and autoimmune diseases, liver cirrhosis (Child-Pugh Class B or C), gastrointestinal disorders as inflammatory bowel disease, malabsorption, history of organ transplantation excluding kidney transplantation who may be included in a separate analysis if sufficient numbers are recruited, receiving total parenteral nutrition, Cu or Zn metabolism disorders as Wilson's disease, vitamin complex supplementation or antioxidants within the past 6 months, recent hospitalization within the past 3 months, recent surgery within 3 months, recent blood transfusion < 3 months, Pregnancy or lactation, Malignancy.
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
Nephrology and urology hospital, Minia unersity hospital, Faculty of medicine, Minia university
Minya
Shima Hassan Hamdy, MD of Internal medicine
About this study
Official title: Impact of Copper to Zinc Ratio on Outcome of End Stage Renal Disease Patients
The goal of this observational clinical trial is to Study the impact of copper to zinc ratio on the outcome of ESRD patients
Read the detailed description
End-stage renal disease (ESRD) carries high morbidity and mortality due to cardiovascular complications, highlighting the need for ongoing research. Trace elements as copper (Cu), and zinc (Zn), are essential for physiological functions, enzyme activity, metabolism, and immune defense. In ESRD patients, Cu and Zn imbalances, with a higher Cu/Zn ratio are linked to greater cardiovascular problems. The relationship between the Cu/Zn ratio and clinical outcomes in ESRD needs more exploration
- Conditions
- ESRD (End Stage Renal Disease), Control Condition
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ESRD patients | 100 patients on maintainance hemodialysis | |
| Control groub | 50 Healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether an elevated serum Cu/Zn ratio is associated with an increased risk of cardiac complications in chronic hemodialysis patients.
measuring serum Cu/Zn ratio and determining if it is associated with an increased risk of cardiac complications in chronic hemodialysis patients.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ESRD (End Stage Renal Disease)Studies of the same condition, open and under way.
- More trials run by Minia 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolles Adel Estawrow Saleh, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109778
- Sponsor's protocol ID
- Copper to Zinc ratio in ESRD
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xie Y, Liu F, Zhang X, Jin Y, Li Q, Shen H, Fu H, Mao J. Benefits and risks of essential trace elements in chronic kidney disease: a narrative review. Ann Transl Med. 2022 Dec;10(24):1400. doi: 10.21037/atm-22-5969.
PubMed 36660676Ruiz-Cabello P, Soriano-Maldonado A, Delgado-Fernandez M, Alvarez-Gallardo IC, Segura-Jimenez V, Estevez-Lopez F, Camiletti-Moiron D, Aparicio VA. Association of Dietary Habits with Psychosocial Outcomes in Women with Fibromyalgia: The al-Andalus Project. J Acad Nutr Diet. 2017 Mar;117(3):422-432.e1. doi: 10.1016/j.jand.2016.09.023. Epub 2016 Nov 24.
PubMed 27890478Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.
PubMed 19414839Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.
PubMed 16004657Duerksen DR, Laporte M, Jeejeebhoy K. Evaluation of Nutrition Status Using the Subjective Global Assessment: Malnutrition, Cachexia, and Sarcopenia. Nutr Clin Pract. 2021 Oct;36(5):942-956. doi: 10.1002/ncp.10613. Epub 2020 Dec 29.
PubMed 33373482Devlin N, Pickard S, Busschbach J. The Development of the EQ-5D-5L and its Value Sets. 2022 Mar 24. In: Devlin N, Roudijk B, Ludwig K, editors. Value Sets for EQ-5D-5L: A Compendium, Comparative Review & User Guide [Internet]. Cham (CH): Springer; 2022. Chapter 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK589306/
PubMed 36810043Cannas D, Loi E, Serra M, Firinu D, Valera P, Zavattari P. Relevance of Essential Trace Elements in Nutrition and Drinking Water for Human Health and Autoimmune Disease Risk. Nutrients. 2020 Jul 13;12(7):2074. doi: 10.3390/nu12072074.
PubMed 32668647
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Copper to Zinc Ratio on Outcome of End Stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT07109778
- Acronym / sponsor ID
- Copper to Zinc ratio in ESRD
- Conditions
- ESRD (End Stage Renal Disease), Control Condition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 7 Aug 2025 (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 goal of this observational clinical trial is to Study the impact of copper to zinc ratio on the outcome of ESRD patients
Detailed description
End-stage renal disease (ESRD) carries high morbidity and mortality due to cardiovascular complications, highlighting the need for ongoing research. Trace elements as copper (Cu), and zinc (Zn), are essential for physiological functions, enzyme activity, metabolism, and immune defense. In ESRD patients, Cu and Zn imbalances, with a higher Cu/Zn ratio are linked to greater cardiovascular problems. The relationship between the Cu/Zn ratio and clinical outcomes in ESRD needs more exploration
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESRD patients | – | –100 patients on maintainance hemodialysis |
| Control groub | – | –50 Healthy individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- this prospective observational Case control study will enroll a well-characterized cohort of 100 adult patients with ESRD(eGFR <15 mL/min/1.73 m²) , including those undergoing maintenance hemodialysis recruited from nephrology clinics and dialysis unit at Minia University Hospital . The recruited patients will be stratified into two groups; 1. Dialysis ESRD Group: It will include 100 adult patients with ESRD stage 5D on maintenance hemodialysis for at least 6 months. 2. control groub study the impact of Cu/Zn ratio on outcomme of ESRD patients
Key inclusion criteria (1 listed)
- ESRD patients including those on maintenance HD
Key exclusion criteria (1 listed)
- Acute kidney injury or rapidly progressive glomerulonephritis, acute infections or active inflammatory conditions as sepsis and autoimmune diseases, liver cirrhosis (Child-Pugh Class B or C), gastrointestinal disorders as inflammatory bowel disease, malabsorption, history of organ transplantation excluding kidney transplantation who may be included in a separate analysis if sufficient numbers are recruited, receiving total parenteral nutrition, Cu or Zn metabolism disorders as Wilson's disease, vitamin complex supplementation or antioxidants within the past 6 months, recent hospitalization within the past 3 months, recent surgery within 3 months, recent blood transfusion < 3 months, Pregnancy or lactation, Malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine whether an elevated serum Cu/Zn ratio is associated with an increased risk of cardiac complications in chronic hemodialysis patients.
Time frame: 6-8 months
measuring serum Cu/Zn ratio and determining if it is associated with an increased risk of cardiac complications in chronic hemodialysis patients.
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 7 Aug 2025.
- Background: PubMed 36660676Xie Y, Liu F, Zhang X, Jin Y, Li Q, Shen H, Fu H, Mao J. Benefits and risks of essential trace elements in chronic kidney disease: a narrative review. Ann Transl Med. 2022 Dec;10(24):1400. doi: 10.21037/atm-22-5969.
- Background: PubMed 27890478Ruiz-Cabello P, Soriano-Maldonado A, Delgado-Fernandez M, Alvarez-Gallardo IC, Segura-Jimenez V, Estevez-Lopez F, Camiletti-Moiron D, Aparicio VA. Association of Dietary Habits with Psychosocial Outcomes in Women with Fibromyalgia: The al-Andalus Project. J Acad Nutr Diet. 2017 Mar;117(3):422-432.e1. doi: 10.1016/j.jand.2016.09.023. Epub 2016 Nov 24.
- Background: PubMed 19414839Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J; CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009 May 5;150(9):604-12. doi: 10.7326/0003-4819-150-9-200905050-00006.
- Background: PubMed 16004657Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005 Jun;44(Pt 2):227-39. doi: 10.1348/014466505X29657.
- Background: PubMed 33373482Duerksen DR, Laporte M, Jeejeebhoy K. Evaluation of Nutrition Status Using the Subjective Global Assessment: Malnutrition, Cachexia, and Sarcopenia. Nutr Clin Pract. 2021 Oct;36(5):942-956. doi: 10.1002/ncp.10613. Epub 2020 Dec 29.
- Background: PubMed 36810043Devlin N, Pickard S, Busschbach J. The Development of the EQ-5D-5L and its Value Sets. 2022 Mar 24. In: Devlin N, Roudijk B, Ludwig K, editors. Value Sets for EQ-5D-5L: A Compendium, Comparative Review & User Guide [Internet]. Cham (CH): Springer; 2022. Chapter 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK589306/
- Background: PubMed 32668647Cannas D, Loi E, Serra M, Firinu D, Valera P, Zavattari P. Relevance of Essential Trace Elements in Nutrition and Drinking Water for Human Health and Autoimmune Disease Risk. Nutrients. 2020 Jul 13;12(7):2074. doi: 10.3390/nu12072074.
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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.
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 ESRD (End Stage Renal Disease) and Control Condition, run by Minia 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 7 Aug 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. 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?
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 Kerolles Adel Estawrow Saleh, MBChB (01227657867, Kerolesadel1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether an elevated serum Cu/Zn ratio is associated with an increased risk of cardiac complications in chronic hemodialysis patients. (time frame: 6-8 months). 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 NCT07109778, which also lists 7 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 7 Aug 2025.