NCT05696977

Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the effect of obesity on therapeutic response and safety of cyclosporine trough level in nephrotic syndrome patients and calculating a suitable weight-based dose.

Detailed description

1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University. 2. Agreement from all participants should be taken in this clinical study by assigning an informed consent. 3. Nephrotic diseased patients,will be recruited from Alexandria main university hospital (AMUH). 4. The 74 participants will be non-randomly assigned into 2 groups. 5. The control group is non-obese nephrotic patients with BMI \<25 kg/m2 will receive receive Cyclosporine capsule with conventional initial dose 3 mg/kg/day using actual weight. 6. The Case interventional group is Obese nephrotic patients with BMI\> 25kg/m2 will receive Cyclosporine capsule with the best weight based dose to achieve the targeted therapeutic trough level and targeted urinary protein/ creatinine ratio. 7. All patients will be subjected to : * First visit: Full patient history, anthropometrics (weight, hight, BMI, fat %, water %, muscles% and clinical examination. Calculate the initial cyclosporine dose 3mg/kg/day in 2 divided doses based on actual weight. * Second visit after one month: blood sample withdrawal for measuring trough level, lipid profile and thyroid profile, urinary sample to measure uPCR If patients don't reach to targeted therapeutic trough level and targeted urinary protein/ creatinine ratio,re-modifying the dose and repeat the labs after another one month in third visit. * Finally find the best weight can be used to achieve the targeted therapeutic trough level and targeted urinary protein/ creatinine ratio, and its relation with fat content and lipid profile 8. The appropriate Statistical tests will be hold according to study design and parameters (parametric and non-parametric) to evaluate the significance of the results. 9. Results, conclusion, discussion and recommendations will be given.

Conditions

• Nephrotic Syndrome

Interventions

Type	Name	Description
DRUG	Cyclosporine Capsule	Determination of the most appropriate weight based dose of Cyclosporine to achieve the target therapeutic drug level and response and its relation with fat percentage and lipid profile

Timeline

• Start date: 2022-04-17
• Primary completion: 2024-02-01
• Completion: 2024-04-01
• First posted: 2023-01-25
• Last updated: 2023-12-11

Locations

1 site across 1 country: Egypt