Cyclophosphamide versus Mycophenolate Mofetil versus Tacrolimus in Lupus Nephritis Treatment Inductio

Phase 3

Not yet recruiting

• Conditions: Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement

• Registration Number: CTRI/2023/07/055128
• Lead Sponsor: Indian Rheumatology Association

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified