Impact of obesity on cyclosporine levels in nephrotic syndrome patients
Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients
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 |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT05696977 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with liver cirrhosis, cancer, or those who are pregnant or lactating may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Alexandria
- Alexandria University — Alexandria, Egypt (Recruiting)
Study contacts
- Study coordinator: Enas A Mohamed, PharmD
- Email: gs-enas.elkady@alexu.edu.eg
- Phone: 01004344021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.