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

Comparison of Relapse Rate After 12 Weeks Verses 20 Weeks Steroid Therapy for the Management of First Episode of Steroid Sensitive Nephrotic Syndrome: A Randomized Control Trial at Children Hospital, Pakistan Institute of Medical Sciences, Islamabad

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.

Study Overview

• Status: Recruiting
• Conditions: Steroid-Sensitive Nephrotic Syndrome
• Intervention / Treatment: Drug: Prednisolone

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Capital
    • Islamabad, Capital, Pakistan, 44000
      • Recruiting
      • Pakistan Institute of Medical Sciences
      • Contact: Nighat Haider, FCPS; Phone Number: 03212125768; Email: nighathaider@hotmail.com
      • Contact: Jai Krishin, FCPS; Phone Number: 03335094933; Email: jkrishin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; Steroids will be given for short duration of time i-e 12 weeks	Drug: Prednisolone; 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.
ACTIVE_COMPARATOR: Group B; Steroid will be given for longer duration i-e 20 weeks	Drug: Prednisolone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse rate	Relapse rete	2 years

Collaborators and Investigators

• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 22, 2020
• Primary Completion (ANTICIPATED): September 4, 2022
• Study Completion (ANTICIPATED): September 4, 2023

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (ACTUAL): January 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 9, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Nephrotic Syndrome, steroid response, relapse
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Disease; Hypersensitivity; Syndrome; Recurrence; Nephrotic Syndrome; Nephrosis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone
• Other Study ID Numbers: No.F.1-1/2015/ERB/SZABMU/465

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No