Clinical trial NCT05696977: Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients
Official title: Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Nephrotic Syndrome
Keywords: Cyclosporine
Obese patients
Lipoproteins
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open labelled, prospective,non-randomized, two-arms,parallel groups, non-placebo controlled clinical trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cyclosporine level concentration and its correlation to anthropometric measures
timeFrame: 1 month
measure: Determine a suitable weight-based dose for obese patients
timeFrame: 1 month
measure: Measuring the weight as one of anthropometric measures
timeFrame: Day 1
measure: Measuring the height as one of anthropometric measures
timeFrame: Day 1
measure: Measuring the BMI as one of anthropometric measures
timeFrame: Day 1
measure: Measuring some of important in-body anthropometric measures
timeFrame: Day 1
Secondary outcomes:
measure: Assessment of kidney functions
timeFrame: 1 month
measure: Assessment of kidney functions as clearance estimation
timeFrame: 1 month
measure: Assessment of kidney functions as urinary protein release
timeFrame: 1 month
measure: Lipid profile assessment
timeFrame: 1 month
measure: Thyroid function assessment
timeFrame: 1 month
measure: Covid-19 vaccine status assessment
timeFrame: Day 1
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
References: