Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
Conditions
Interventions
Intervention1: IV cyclophosphomide: IV CYC will be administered 0.5 â?? 1 gm/m2 every four weeks for a total of six infusions according to the modified NIH regimen.
Dosing delays of up to seven days a
Sponsors
Indian Rheumatology Association
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosed with SLE according to the ACR/EULAR classification criteria 2019. 2.Age between >=12 years. 3.Lupus nephritis is diagnosed either clinically or biopsy-proven. 4.Clinically: Proteinuria >= 500 mg in 24 h and/or urine routine microscopy showing active cellular casts/sediments [ >5 RBC/high power field (HPF) and >5 WBC/HPF and cellular casts] 5.Kidney biopsy performed within the six months prior to randomization with a histological diagnosis of Class III, IV, V, or a mixture of these classes according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. 6.All patients must give written informed consent prior to enrolment.
Exclusion criteria
Exclusion criteria: 1.Patients ever treated previously with CYC, MMF, TAC or steroids >15 mg/day in the last 3 months before enrolment. 2.Patients with pre-existing chronic renal failure, previous malignancy, liver dysfunction within six months prior to randomization. 3.Patients with previously documented severe toxicity to immunosuppressive drugs. 4.Patients with active acute or chronic infections. 5.Pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal response (CR or PR) at week 24 in the study population.Timepoint: 12 weeks & 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with CR, PR, & NR. Proportion of patients with severe disease flares. Change in C3, C4, and Anti dsDNA antibody levels. Change in Disease activity by SLEDAI â?? 2K. Change in Disease activity by Renal â?? SLEDAI. Change in serum CXCL 10 levels. Adverse eventsTimepoint: 12 weeks & 24 weeks | — |
Countries
India
Contacts
Public ContactAmudalapalli L A Alekhya
IMS and SUM Hospital
Outcome results
None listed