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

Alexandria University

Status and phase: Enrolling; Phase 4

Conditions: Nephrotic Syndrome

Treatments: Drug: Cyclosporine Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT05696977

0107113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Obese nephrotic patients with BMI>25 kg/m2

Active Comparator group

Description:

Nephrotic obese patients receive Cyclosporine capsule initially according to weight-based dose then modifying the dose according to targeted therapeutic level. To determine the best weight can be used to get the targeted therapeutic level. Correlate with the lipid profile, fat percentage and other anthropometric measures.

Treatment:

Drug: Cyclosporine Capsule

Non obese nephrotic patients with BMI<25 kg/m2

Other group

Description:

Nephrotic non-obese patients receive Cyclosporine capsule initially according to weight-based dose then modified dose according to targeted therapeutic level.

Treatment:

Drug: Cyclosporine Capsule