Nephrotic Syndrome
Conditions
Keywords
Cyclosporine, Obese patients, Lipoproteins
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.
Interventions
DRUGCyclosporine 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
Sponsors
Alexandria University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open labelled, prospective,non-randomized, two-arms,parallel groups, non-placebo controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring some of important in-body anthropometric measures | Day 1 | Measuring anthropometric measures as;body fat percentage, body water percentage and muscle percentage content at base line of starting the Cyclosporine regimen. |
| Cyclosporine level concentration and its correlation to anthropometric measures | 1 month | Measuring of Cyclosporine level in whole blood after one month of starting the drug |
| Determine a suitable weight-based dose for obese patients | 1 month | Modifying the Cyclosporine dose according to measured trough level |
| Measuring the weight as one of anthropometric measures | Day 1 | Measuring anthropometric measures as; weight in kilograms at base line of starting the Cyclosporine regimen. |
| Measuring the height as one of anthropometric measures | Day 1 | Measuring anthropometric measures as;height in metres at base line of starting the Cyclosporine regimen. |
| Measuring the BMI as one of anthropometric measures | Day 1 | Measuring anthropometric measures as; BMI (body mass index) in kilograms/meter\^2 at base line of starting the Cyclosporine regimen. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of kidney functions | 1 month | Measuring parameters represent the kidney functions including (serum creatinine in mg/dl.) |
| Assessment of kidney functions as clearance estimation | 1 month | Measuring parameters represent the kidney functions including (estimated GFR in mL/min/1.73 m²) |
| Assessment of kidney functions as urinary protein release | 1 month | Measuring parameters represent the kidney functions including (Urinary protein-creatinine ratio in gm/gm) |
| Lipid profile assessment | 1 month | Measuring lipid profile including (HDL, LDL,VLDL and TG) in mg/dl. |
| Thyroid function assessment | 1 month | Measuring Thyroid profile including (TSH, fT3, fT4 ). |
| Covid-19 vaccine status assessment | Day 1 | Assess if the patient received Covid-19 vaccine, or not. |
Countries
Egypt
Contacts
Primary ContactEnas A Mohamed, PharmD
Backup ContactNoha A Hamdy, PhD
Outcome results
None listed