Comparison of Relapse Rate After 12 Weeks Verses 20 Weeks Steroid Therapy for the Management of First Episode of Steroid Sensitive Nephrotic Syndrome

  • STATUS
    Recruiting
  • End date
    Sep 4, 2023
  • participants needed
    68
  • sponsor
    Shaheed Zulfiqar Ali Bhutto Medical University
Updated on 16 May 2021

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.

Details
Condition Steroid-Sensitive Nephrotic Syndrome
Treatment Prednisolone
Clinical Study IdentifierNCT04713410
SponsorShaheed Zulfiqar Ali Bhutto Medical University
Last Modified on16 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Children 1 to 8 years of age, Diagnose with nephrotic syndrome for the first
time Steroid sensitive nephrotic syndrome

Exclusion Criteria

Steroid resistant nephrotic syndrome Steroid dependent nephrotic syndrome
Syndromic Children Children with other co morbidities
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note