A trial to compare the effectiveness of two different drugs for the treatment of children with nephrotic syndrome.

Phase 3

Completed

Conditions: Nephrotic syndrome with minor glomerular abnormality,

Registration Number: CTRI/2018/07/015143

Lead Sponsor: Jawaharlal Nehru Medical College

Brief Summary: Children with steroid sensitive nephrotic syndrome often have a frequently relapsing or steroid dependent disease. Such patients are put on alternate day tapering prednisolone or alternative medications. However, there is no standard protocol regarding choice of alternative drugs in children with frequently relapsing or steroid dependent nephrotic syndrome. Recent trials have demonstrated the superiority of daily levamisole over alternate day therapy. Daily levamisole has been shown to be effective in at least half the cases who had failed on alternate day levamisole. Based on these observations we hypothesized that daily levamisole therapy could potentially have efficacy to match MMF therapy. There is no trial directly comparing MMF and levamisole in the management of steroid dependent or frequently relapsing nephrotic syndrome in children. Both drugs help in tapering the dose of corticosteroids, thereby reducing the side effects of steroids. Both the drugs have to be given for prolonged periods and both have been shown to be relatively safe in children on long-term use. However, levamisole is a considerably cheaper alternative as compared to MMF, thereby making it an attractive treatment option in resource constrained countries. Although there is very little evidence on which drug is more efficacious in preventing relapses in children with nephrotic syndrome, MMF is generally considered as a superior agent than levamisole given as alternate day treatment.

In this randomized controlled trial we aim to test the therapeutic efficacy of levamisole administered in a daily dose of 2.5 mg/kg/d versus mycophenlate mofetil for a duration of 9 to12 months, in children with frequently relapsing or steroid dependent nephrotic syndrome. We hypothesize that daily levamisole in a dose of 2.5 mg/kg/day, may not be significantly inferior to daily mycophenolate mofetil treatment given in a dose of 1000 mg/m2. The primary objective of the study is to compare changes in relapse frequency at baseline and study end (i.e. after 1 year of treatment). Secondary objectives are to compare safety (side effects), time to first relapse, proportion of patients relapse-free, cumulative steroid dose used and failure of the trial medication.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 42

Inclusion Criteria

Two or more relapses in 6 months while on alternate day levamisole with tapering alternate day prednisolone therapy, or 2.
If the prednisolone threshold to maintain remission exceeds 0.7 mg/kg on alternate days or, 3.
Patients have significant steroid toxicity (cushingoid with hypertension, ocular toxicity such as cataract, glaucoma or an episode of serious life threatening infection).

Exclusion Criteria

1.Age at onset of nephrotic syndrome less than 1 year or more than 10 year.
History of use of alternative treatment other than alternate day levamisole.
Biopsy showing pathology other than MCNS.
Secondary nephrotic syndrome.
Late steroid resistance.
Residing >100 km from centre or unwilling to follow up.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse frequency	At enrolment, 1 year

Secondary Outcome Measures

Name	Time	Method
Side effects	Time to first relapse

Trial Locations

Locations (1): Jawaharlal Nehru Medical College, AMU, Aligarh
🇮🇳
Aligarh, UTTAR PRADESH, India
Jawaharlal Nehru Medical College, AMU, Aligarh
🇮🇳Aligarh, UTTAR PRADESH, India
Kamran Afzal
Principal investigator
drkafzal@hotmail.com