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

NCT05696977 | Unknown Phase 4

• 1 other identifier: 0107113
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrotic Syndrome

Keywords

Cyclosporine; Obese patients; Lipoproteins

Outcome Measures

Primary Outcomes (6)

• 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

• Determine a suitable weight-based dose for obese patients

  Modifying the Cyclosporine dose according to measured trough level

  1 month

• 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

• 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

• 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

• 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 Outcomes (6)

• Assessment of kidney functions

  1 month

• Assessment of kidney functions as clearance estimation

  1 month

• Assessment of kidney functions as urinary protein release

  1 month

• Lipid profile assessment

  1 month

• Thyroid function assessment

  1 month

Study Arms (2)

Obese nephrotic patients with BMI>25 kg/m2

ACTIVE COMPARATOR

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.

Drug: Cyclosporine Capsule

Non obese nephrotic patients with BMI<25 kg/m2

OTHER

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

Drug: Cyclosporine Capsule

Interventions

Cyclosporine Capsule DRUG

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

Non obese nephrotic patients with BMI<25 kg/m2; Obese nephrotic patients with BMI>25 kg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Hepatic patients liver cirrhosis (moderate to severe liver impairment)
• Cancer patients,
• Pregnant and lactating female patients

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Enas A Mohamed, PharmD

CONTACT

01004344021; gs-enas.elkady@alexu.edu.eg

Noha A Hamdy, PhD

CONTACT

01005182151; noha.alaaeldine@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open labelled, prospective,non-randomized, two-arms,parallel groups, non-placebo controlled clinical trial

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 25, 2023
• Study Start: April 17, 2022
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)