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

Nephrotic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05696977
• Other study ID #: 0107113
• Status: Recruiting
• Phase: Phase 4
• Start date: April 17, 2022
• Est. completion date: April 2024

Study information

• Verified date: December 2023
• Source: Alexandria University
• Contact: Enas A Mohamed, PharmD
• Phone: 01004344021
• Email: gs-enas.elkady[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: April 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cyclosporine level concentration and its correlation to anthropometric measures	Measuring of Cyclosporine level in whole blood after one month of starting the drug	1 month
Primary	Determine a suitable weight-based dose for obese patients	Modifying the Cyclosporine dose according to measured trough level	1 month
Primary	Measuring the weight as one of anthropometric measures	Measuring anthropometric measures as; weight in kilograms at base line of starting the Cyclosporine regimen.	Day 1
Primary	Measuring the height as one of anthropometric measures	Measuring anthropometric measures as;height in metres at base line of starting the Cyclosporine regimen.	Day 1
Primary	Measuring the BMI as one of anthropometric measures	Measuring anthropometric measures as; BMI (body mass index) in kilograms/meter^2 at base line of starting the Cyclosporine regimen.	Day 1
Primary	Measuring some of important in-body anthropometric measures	Measuring anthropometric measures as;body fat percentage, body water percentage and muscle percentage content at base line of starting the Cyclosporine regimen.	Day 1
Secondary	Assessment of kidney functions	Measuring parameters represent the kidney functions including (serum creatinine in mg/dl.)	1 month
Secondary	Assessment of kidney functions as clearance estimation	Measuring parameters represent the kidney functions including (estimated GFR in mL/min/1.73 m²)	1 month
Secondary	Assessment of kidney functions as urinary protein release	Measuring parameters represent the kidney functions including (Urinary protein-creatinine ratio in gm/gm)	1 month
Secondary	Lipid profile assessment	Measuring lipid profile including (HDL, LDL,VLDL and TG) in mg/dl.	1 month
Secondary	Thyroid function assessment	Measuring Thyroid profile including (TSH, fT3, fT4 ).	1 month
Secondary	Covid-19 vaccine status assessment	Assess if the patient received Covid-19 vaccine, or not.	Day 1