A clinical trial to compare the effectiveness and safety of treating the initial episode of nephrotic syndrome in children for a duration of three months versus six months

Active, not recruiting

• Conditions: Initial episode of steroid sensitive nephrotic syndrome

• Registration Number: CTRI/2010/091/001095
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

This study is a randomized, double blind, parallel group, multicentric trial comparing the safety and efficacy of therapy of initial episode of nephrotic syndrome with prednisolone for three months versus six months, following standard therapy with prednisolone for three months, patients will receive either prednisolone or placebo in tapering doses on alternate days for three months. The study shall be conducted at one center in India. The primary outcome measure is the comparison of relapse rates in the two groups of patients over the next one year, while secondary outcomes include the time to first relapse (in days) after discontinuation of initial treatment, the proportion of patients with frequent relapses at 1 year & 2 years of follow up, the cumulative prednisolone requirement (mg/kg/day) at 1 year, the use of alternative medications at 1 year, and the side effects of corticosteroids at the end of initial therapy and at 1 year.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-07
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Patients with idiopathic, steroid sensitive nephrotic syndrome 2.
• First episode of nephrotic syndrome 3.
• Age 1 to 12 years.

Exclusion Criteria

1.Nephrotic syndrome known to be secondary to a systemic disorder, e.g., IgA nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, amyloidosis, hepatitis B antigenemia and Alport syndrome.2.Patients with impaired renal functions (serum creatinine > 1.2 mg/dl, confirmed within 2 weeks)3.Patients who have received oral prednisolone, in the past for nephrotic syndrome4.Patients who have taken prednisolone in the past 4 weeks, in a dose more than 1 mg/kg for >10 days for any other reason5.Unclear treatment history.6.Patients staying more than 100 km from the Institute or those not willing to come for clinic visits every two months7.Gross hematuria8.Patients with initial steroid resistance9.Patients who show relapse within the first 3 months of therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence of relapse during one year follow up, in patients receiving 6 months versus 3 months of prednisolone therapy for the initial episode of nephrotic syndrome	one year after cessation of therapy with prednisolone

Secondary Outcome Measures

Name	Time	Method
1)The time to first relapse (days) after discontinuation of initial treatment	2)The proportion of patients with frequent relapses at 1 year, after discontinuation of initial therapy

Trial Locations

Locations (5)

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Chacha Nehru Bal Chikitsalaya; 🇮🇳 Delhi, DELHI, India

Dr. Ram Manohar Lohia Hospital; 🇮🇳 Delhi, DELHI, India

Jawahar Lal Nehru Medical College, ALigarh Muslim University; 🇮🇳 Aligarh, UTTAR PRADESH, India

Sawai Man Singh (SMS) Medical College; 🇮🇳 Jaipur, RAJASTHAN, India

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Arvind Bagga

Principal investigator

011-26593472

arvindbagga@hotmail.com