Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04713410 |
| Other study ID # |
No.F.1-1/2015/ERB/SZABMU/465 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 22, 2020 |
| Est. completion date |
September 4, 2023 |
Study information
| Verified date |
May 2021 |
| Source |
Shaheed Zulfiqar Ali Bhutto Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
All children from 1 to 8 years of age, diagnose with nephrotic syndrome for the first time
will be divided into two groups. One group will be given steroids for 12 weeks and other
group will receive steroid for 20 weeks. During the 1 years after completion of steroid
course patients will be monitor for the episodes of relapse in both group.
Description:
All children from 1 to 8 years of age, diagnose with nephrotic syndrome for the first time,
at Pakistan Institute of Medical Sciences, Islamabad, from December 2020 to December 2022
will be included in the study.
Sample size was calculated by using WHO sample size calculator keeping level of significance
5%, power of test 90%, P1 21.6%7 and P2 59.3%8. The sample size is turned out to be 34
patients in each group with total of 68 patients.
The patients fulfilling the inclusion criteria will be registered at our nephrology clinic.
Patients' bio data along with history and examination will be recorded on a proforma. They
will be divided in two groups designated as A and B. Group A will receive steroid for 12
weeks and group B for 20 weeks. For group A regimen will be to administer prednisolone as a
single dose of 60 mg/m2 once daily for 6 weeks, then 40 mg/m2 on alternate day for another 6
weeks and then stop. For group B prednisolone will be given as a single dose of 60 mg/m2 once
daily for 6 weeks, then 40 mg/m2 on alternate day for another 6 weeks with tapering of 25% of
alternate day dose fortnightly. Outcome will be measured in terms of number of relapses in
the subsequent 1 years after stopping steroids.
For treatment of relapse Prednisolone will be given in the dose of 60 mg/m2 once daily till
urine protein is negative or trace for 3 consecutive days, then 40 mg/m2 on alternate day for
1 month then stop. In case of frequent relapses and steroid dependent cases, relapses will be
treated as follows; prednisolone 60 mg/m2 on alternate day till urine protein will be
negative for 5days then 40 mg/m2 on alternate day for 1 month then with tapering at the rate
of 5 mg fortnightly.
Children with congenital and infantile nephrotic syndrome, persistent hypertension, gross
haematuria, family history of nephrotic syndrome and age below 1 year and above 8 years will
be excluded from study.
After approval of study from ethical review board, informed consent will be taken from
parents. The data obtained will be analyzed using SPSS version 20. The t test will be applied
for comparison of mean and chi sqare test for comparison of percentages. The p value less
than .05 will be taken as significant.
