Cyclophosphamide Versus Mycophenolate Mofetil in Lupus Nephritis

• Status: Completed
• Trial end date: 2015-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chitwan Medical College
• Treatments: Cyclophosphamide; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Newly diagnosed LN with ISN/RPS histopathology classes III to V

Exclusion Criteria:

• Patients with biopsy had proven ISN / RPS classes I, II and VI LN

• Patients with previous history of treatment and relapse of lupus nephritis

• Patients who were receiving continuous dialysis for more than two weeks prior to randomization.

• Patients of less than 12 years of age

• Patients who had concurrent infection or illness at the time of enrollment

• Patients who were taking concurrent medications which are supposed to have interactions with MMF or CYC

• Female patients who were pregnant and breastfeeding.

• Patients who did not give consent for participation