Cyclophosphamide Versus Mycophenolate Mofetil in Lupus Nephritis
Status:
Completed
Trial end date:
2015-06-30
Target enrollment:
Participant gender:
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.