Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696977
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2022-12-15
Brief Title:
Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Effect of Obesity on Cyclosporine Blood Trough Level in Nephrotic Syndrome Patients
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientswill 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 kgm2 will receive receive Cyclosporine capsule with conventional initial dose 3 mgkgday using actual weight
6 The Case interventional group is Obese nephrotic patients with BMI 25kgm2 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 3mgkgday 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 dont reach to targeted therapeutic trough level and targeted urinary protein creatinine ratiore-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
2 Agreement from all participants should be taken in this clinical study by assigning an informed consent
3 Nephrotic diseased patientswill 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 kgm2 will receive receive Cyclosporine capsule with conventional initial dose 3 mgkgday using actual weight
6 The Case interventional group is Obese nephrotic patients with BMI 25kgm2 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 3mgkgday 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 dont reach to targeted therapeutic trough level and targeted urinary protein creatinine ratiore-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None