A study to compare the effectiveness of oral mycophenolate mofetil (MMF) and tacrolimus for treating children with nephrotic syndrome which does not respond to steroids.
- Conditions
- Health Condition 1: null- Newly diagnosed patients of steroid sensitive nephrotic syndrome
- Registration Number
- CTRI/2012/03/002479
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 96
1.Age 1-18 years at onset of disease
2.Confirmed steroid resistance (initial or late resistance), defined as no response to treatment with oral prednisolone at 2 mg/kg/day for 4 weeks, in absence of significant infection
3.Urine protein creatinine ratio (Up/Uc) >2.0 mg/mg creatinine on first a.m. void, or 24-hr urinary protein exceeding 1 g/m2
4.Renal biopsy showing minimal change disease or focal segmental glomerulosclerosis (FSGS). A minimum of one glomerulus showing segmental sclerosis is required for the latter diagnosis
5.Informed parental consent, with willingness to follow the clinical trial protocol, including medications, future randomization, baseline and follow-up visits and procedures
1.Patients with initial steroid resistance who have received treatment with immunosuppressive medications other than oral prednisolone, IV methylprednisolone or dexamethasone. Patients who have, at any time, received treatment with alkylating agents, CNI (cyclosporine, tacrolimus), azathioprine or MMF exceeding 14 days, or any IV dose of vincristine or rituximab shall be excluded.
2.Patients with late steroid resistance who have ever received MMF or tacrolimus exceeding 14 days; or other immunosuppressive medications in the preceding 3 months.
3.Patients staying more than 200 km from the Institute or those not willing to come for 2-monthly follow-up visits
4.Nephrotic syndrome due to diffuse mesangial sclerosis, membranous nephropathy and membranoproliferative GN
5.Symptomatic or asymptomatic infection with hepatitis B, C, parvovirus or human immunodeficiency virus
6.Secondary nephrotic syndrome, e.g., associated with above infections, post-infectious glomerulonephritis, IgA nephropathy, Henoch Schonlein purpura, systemic lupus erythematosus, vasculitis, amyloidosis, vesicoureteric reflux and Alport syndrome, medications and malignancy
7.Active tuberculosis. However, patients with isolated positive tuberculin test (PPD >10 mm) without clinical or radiological evidence of disease shall receive prophylaxis with INH [5 mg/kg/day for 6 months] commencing at least 2 weeks prior to enrolment
8.Estimated GFR <60 ml/min/1.73 m² at most recent measure prior to enrolment
9.Hemoglobin <9 g/dl, leukopenia (leukocytes <4000/m3), thrombocytopenia (platelets <150,000/mm3)
10.Known allergy to any of the study medications
11.History of malignancy, diabetes mellitus, organ or bone marrow transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Examine in a prospective open label, randomized controlled trial, the efficacy of 12-months treatment with mycophenolate mofetil (MMF) and alternate day prednisolone versus tacrolimus and alternate day prednisolone in maintaining remission in patients with steroid resistant nephrotic syndrome, who have previously achieved remission following 6-months therapy with tacrolimusTimepoint: one year
- Secondary Outcome Measures
Name Time Method Compare the outcomes (complete remission, partial remission, steroid sensitive relapses, recurrence of steroid resistance) at 6-months and one-year follow up, proportion of patients with treatment failure at one-year follow up, time to first relapse in the two groups. Ascertain the frequency of relapses during follow-up, the frequency and type of adverse effectsTimepoint: one year