Cyclophosphamide Versus Mycophenolate Mofetil in Lupus Nephritis

PHASE2CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

January 1, 2014

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
To Compare the Effects of Mycophenolate Mofetil With Cyclophosphamide in Neplaese Lupus Nephritis Patients
Interventions
DRUG

Cyclophosphamide

Cyclophosphamide injection was administered in the dose of 0.5 to 1 gram per m2 of body surface area. The medicine, which is available in the strength of 1 gram in powder form, was first dissolved in 20 ml of normal saline. Only15 ml of this preparation was mixed in 100 ml of normal saline and was infused over a period of one hour. CYC was not given to those patients who had total leukocyte counts (TLC) less than 2500/mm3. Those patients were re-evaluated after one week and intravenous pulse CYC was reinstituted if the TLC exceeds 2500/mm3. Pulse CYC was administered every month for a total of six infusions.

DRUG

Mycophenolate Mofetil

Participants in the MMF group were administered tablet mycophenolate mofetil at a starting dose of 500 mg twice daily if the weight of the patient was less than 50 kilograms and 750 mg twice daily if the weight was more than 50 kilograms. After one month, the dose of MMF was increased to 750 mg twice daily. The clinical response was monitored in terms of reduction in serum creatinine and proteinuria. MMF dose was decreased or interrupted in patients experiencing an absolute neutrophil count \<1300/mm3 at any study visit; MMF treatment was discontinued if a patient experienced an absolute neutrophil count \<1000/mm3.

Sponsors
All Listed Sponsors
lead

Chitwan Medical College

OTHER