Impact of obesity on cyclosporine levels in nephrotic syndrome patients
Official title: Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients
Run by Alexandria University · NCT05696977 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing how being obese affects the way cyclosporine works for people with nephrotic syndrome by comparing treatment responses between obese and non-obese patients.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 74 (estimated) |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT05696977 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult nephrotic syndrome patients who are either obese or non-obese and have been receiving cyclosporine for more than one month.
✕Probably not a fit
Patients with liver cirrhosis, cancer, or those who are pregnant or lactating may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates how obesity affects the therapeutic response and safety of cyclosporine in patients with nephrotic syndrome. It involves recruiting 74 participants from Alexandria University Hospital, who will be divided into two groups: obese patients with a BMI over 25 kg/m2 and non-obese patients with a BMI under 25 kg/m2. Both groups will receive cyclosporine, but the obese group will have their doses adjusted based on their weight to achieve optimal therapeutic levels. The study will monitor blood and urine samples over a three-month period to assess treatment efficacy.
Why it matters
Potential benefit: If successful, this study could lead to more effective dosing strategies for cyclosporine in obese nephrotic syndrome patients, improving their treatment outcomes.
How similar studies have gone: While there is limited data on this specific approach, studies examining weight-based dosing in other medications have shown promise, suggesting potential for success in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Obese and overweight Nephrotic syndrome adult patients receiving Cyclosporine for more than one month with prednisolone. (BMI\>25 kg/m2) * Normal or underweight individuals Nephrotic syndrome adult patients receiving Cyclosporine for more than one month with prednisolone. (serving as control group) Exclusion Criteria: * Hepatic patients liver cirrhosis (moderate to severe liver impairment) * Cancer patients, * Pregnant and lactating female patients
Where it's running
-
Alexandria University
Alexandria, Egypt Recruiting
Study contacts
- Study coordinator: Enas A Mohamed, PharmD
- Email: gs-enas.elkady@alexu.edu.eg
- Phone: 01004344021
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.