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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.
Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
Agreement from all participants should be taken in this clinical study by assigning an informed consent.
Nephrotic diseased patients,will be recruited from Alexandria main university hospital (AMUH).
The 74 participants will be non-randomly assigned into 2 groups.
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.
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.
All patients will be subjected to :
The appropriate Statistical tests will be hold according to study design and parameters (parametric and non-parametric) to evaluate the significance of the results.
Results, conclusion, discussion and recommendations will be given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of kidney functions | Measuring parameters represent the kidney functions including (serum creatinine in mg/dl.) | 1 month |
| Assessment of kidney functions as clearance estimation | Measuring parameters represent the kidney functions including (estimated GFR in mL/min/1.73 m²) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Enas A Mohamed, PharmD | Contact | 01004344021 | +2 | gs-enas.elkady@alexu.edu.eg |
| Noha A Hamdy, PhD | Contact | 01005182151 | +2 | noha.alaaeldine@alexu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Recruiting | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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Open labelled, prospective,non-randomized, two-arms,parallel groups, non-placebo controlled clinical trial
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| 1 month |
| Assessment of kidney functions as urinary protein release | Measuring parameters represent the kidney functions including (Urinary protein-creatinine ratio in gm/gm) | 1 month |
| Lipid profile assessment | Measuring lipid profile including (HDL, LDL,VLDL and TG) in mg/dl. | 1 month |
| Thyroid function assessment | Measuring Thyroid profile including (TSH, fT3, fT4 ). | 1 month |
| Covid-19 vaccine status assessment | Assess if the patient received Covid-19 vaccine, or not. | Day 1 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |