Comparison of high dose versus low dose immunosuppressive therapy with steroid modification as induction therapy in proliferative lupus nephritis: Randomized control trial.

Comparison of modified Euro Lupus regimen with modified NIH protocol as induction therapy in proliferative lupus nephritis: Randomized control trial.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/07/019975

Enrollment

214

Registered

2019-07-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Systemic Lupus Erythematosus with proliferative lupus nephritis Health Condition 2: M321- Systemic lupus erythematosus withorgan or system involvement

Interventions

Intervention1: modified Euro Lupus: Cyclophosphamide - Low dose IV-CYC (500 mg fortnightly for six cycles) followed by azathioprine 2 mg/kg after 12 weeks of induction (3). Corticosteroids â?? â?¢

Eligibility

Inclusion criteria

Inclusion criteria: 1) Diagnosis of SLE according to Systemic Lupus International Collaborating Clinic criteria for classification of SLE (SLICC criteria). 2) Age 18 years or above 3) Proteinuria >=500 mg in 24 hour and/or urine routine microscopy showing active cellular casts/sediments( >5 RBC/HPF and >5 WBC/HPF and cellular casts) 4) Biopsy-proven proliferative lupus nephritis of class III and/or IV according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria.

Exclusion criteria

Exclusion criteria: 1) Patients ever treated previously with intravenous or oral cyclophosphamide, mycophenolate mofetil, cyclosporine or steroid (prednisone equivalent) >15 mg/day in last 3 months. 2) Patients with previously documented severe toxicity to immunosuppressive drugs. 3) Patient with renal thrombotic microangiopathy, preexisting chronic renal failure, diabetes mellitus or coronary heart disease. 4) Pregnancy or woman in reproductive age group who have not yet completed family and not willing for contraception as required. 5) History of previous malignancy or family history of malignancy

Design outcomes

Primary

Measure	Time frame
Renal response as per EULAR definitionTimepoint: 12 weeks, 24 weeks and 48 weeks	—

Secondary

Measure	Time frame
1. Assessment of rate of renal relapse and disease flare 2. Assessment of adverse events and safety Timepoint: 12 weeks, 24 weeks and 48 weeks	—

Countries

India

Contacts

Public ContactDr Sanket Shah

Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)

vsnegi22@yahoo.co.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026