Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients
NCT ID: NCT05696977
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
74 participants
INTERVENTIONAL
2022-04-17
2024-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Obese nephrotic patients with BMI>25 kg/m2
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.
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
Non obese nephrotic patients with BMI<25 kg/m2
Nephrotic non-obese patients receive Cyclosporine capsule initially according to weight-based dose then modified dose according to targeted therapeutic level.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Normal or underweight individuals Nephrotic syndrome adult patients receiving Cyclosporine for more than one month with prednisolone. (serving as control group)
Exclusion Criteria
* Cancer patients,
* Pregnant and lactating female patients
18 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Locations
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Alexandria University
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Noha A Hamdy, PhD
Role: primary
Yasmin S Naga, PhD
Role: backup
Other Identifiers
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0107113
Identifier Type: -
Identifier Source: org_study_id