Cyclophosphamide Versus Mycophenolate Mofetil in Lupus Nephritis

Summary

This was a prospective open label randomized control trial, which was conducted for a period of one and half year from January 2014 to June 2015. Out of 52 patients screened, 49 patients meeting the international society of nephrology/ renal pathology society (ISN/RPS) criteria were enrolled in the study comprising of 25 and 24 patients in the cyclophosphamide (CYC) and mycophenolate mofetil (MMF) groups respectively. Forty two patients (21 in each group) could complete the study till the end of 6 months and were included in final analysis. Baseline clinical evaluation and investigations were done and recorded. CYC was given intravenously as a monthly pulse in the dose of 0.5 to 1 gram per m2 body surface area. MMF was administered in the tablet form with the starting dose of 500 mg twice daily, which was increased to 750 mg twice daily after a month. Patients were assessed and monitored monthly and the details were recorded. Efficacy of treatment was measured as primary end point for those who achieved partial remission (reduction of 24 hour urinary protein to \< 3.5gms/day if baseline proteinuria \>3.5 gms/day or decrease by 50% if baseline proteinuria \<3.5 gms/day) and secondary end point for those who achieved complete remission (normalization of serum creatinine and \< 500 mg of 24 hour urinary protein). Adverse events experienced by the patients were also recorded during monthly visit.

Timeline

Start

2014-01-01

Primary completion

2015-06-30

Completion

2015-06-30

Publications

• Sedhain A, Hada R, Agrawal RK, Bhattarai GR, Baral A. Low dose mycophenolate mofetil versus cyclophosphamide in the induction therapy of lupus nephritis in Nepalese population: a randomized control trial. BMC Nephrol. 2018 Jul 11;19(1):175. doi: 10.1186/s12882-018-0973-7.

Drugs

Indications

No indication recorded.