CompletedPhase 4

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

India75 participantsStarted 2015-12

Plain-language 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.

Who can participate

Age range16 Years

SexALL

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Inclusion criteria

✓. A diagnosis of SLE according to the American College of Rheumatology (ACR) criteria
✓. Age \>16 years
✓. Proteinuria ≥500 mg in 24 hours/ urine routine microscopy showing active cellular casts/sediments.
✓. Biopsy-proven proliferative lupus glomerulonephritis of class III, IV according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria.

Exclusion criteria

✕. Patients ever treated previously with intravenous or oral cyclophosphamide or received steroids \>15mg/day in the last 3 months.
✕. Patients with renal thrombotic microangiopathy, preexisting chronic renal failure, pregnancy, previous malignancy (except skin and cervical intraepithelial neoplasia), diabetes mellitus or coronary heart disease.
✕. Patients with previously documented severe toxicity to immunosuppressive drugs.
✕. Patients with acute/chronic infections.
✕. Pregnancy

What they're measuring

Assessment of Primary Renal Response

Timeframe: 12 months

Trial details

NCT IDNCT02645565

SponsorJawaharlal Institute of Postgraduate Medical Education & Research

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2016-12

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