Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05696977
Study type	Interventional
Source	Alexandria University
Contact	Enas A Mohamed, PharmD
Phone	01004344021
Email	gs-enas.elkady@alexu.edu.eg
Status	Recruiting
Phase	Phase 4
Start date	April 17, 2022
Completion date	April 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms