A clinical trial to study the effect and safety of intravenous cyclophosphamide and tacrolimus in children with steroid resistant nephrotic syndrome

A prospective , randomized controlled trial comparing the efficacy of intravenous cyclophosphamide and alternate day prednisolone versus tacrolimus and alternate day prednisolone for induction of remission in patients with steroid resistant nephrotic syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000215

Enrollment

130

Registered

2009-05-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Comparing two drug regimens , intravenous cyclophosphamide and tacrolimus with alternate day steroids: Cyclphosphamide at a dose of 500 mg/sg m for 6 months versus tacrolimus 0.12 mg/kg

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Proportion in sustained remission and with steroid sensitive relapses at one-year follow up Frequency and type of side effects in both the groups during one year follow up Number of life- threatening infection associated events in both the groups Timepoint: 12 months	—

Countries

India

Contacts

Public ContactProf Arvind Bagga

arvindbagga@hotmail.com011-26593472

Outcome results