A clinical trial to study the effect and safety of intravenous cyclophosphamide and tacrolimus in children with steroid resistant nephrotic syndrome
Phase 4
- Registration Number
- CTRI/2008/091/000215
- Lead Sponsor
- il
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 130
Inclusion Criteria
Newly diagnosed patients with idiopathic steroid resistant nephrotic syndrome
(initial or late resistance), 1 to 16 years old , shall be studied . Standard definitions will be used for defining the course of nephrotic syndrome
Exclusion Criteria
Patients with impaired renal functions (GFR<60ml/mt/sqm , serum creatinine > 1.2 mg/dl or urea > 45 mg/dl, confirmed once over a period of 2 weeks).
Patients who have received immunosuppressive medications, other than oral prednisolone, in the preceding 6 months.
Patients staying more than 200 km from the Institute or those who not willing to come for monthly visits.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of remission (complete or partial) at six months in patients receiving intravenous cyclophosphamide and alternate day prednisolone versus those receiving tacrolimus and alternate day prednisolone.Timepoint: 6 months
- Secondary Outcome Measures
Name Time Method Proportion in sustained remission and with steroid sensitive relapses at one-year follow up <br/ ><br>Frequency and type of side effects in both the groups during one year follow up <br/ ><br> <br/ ><br>Number of life- threatening infection associated events in both the groups <br/ ><br> <br/ ><br>Timepoint: 12 months