drugset / Trial / NCT02645565

Comparison of Low Dose Versus High Dose Cyclophosphamide as Induction Therapy in the Treatment of Lupus Nephritis

NCT02645565

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will be conducted to find out whether low dose or high dose cyclophosphamide therapy is effective in the treatment of proliferative lupus nephritis.It will also compare the side effects and risks of infection in low dose and high dose cyclophosphamide group. Half of the participants will receive a low dose cyclophosphamide for 3 months and half will receive high dose cyclophosphamide therapy monthly for 6 months followed by azathioprine 2 mg/kg.

Timeline

Start
2015-12
Primary completion
2016-12
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified 500 mg Intravenous
Comparator Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Comparator Azathioprine Small molecule 2 mg/kg
Comparator Methylprednisolone Other / unclassified 1 g Intravenous

Indications