Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis

Summary

This study is for individuals with lupus who have developed complications in their kidneys, or lupus nephritis. The study will determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis than standard cyclophosphamide therapy by itself.

Conditions

• Lupus Nephritis
• Lupus Erythematosus, Systemic

Interventions

DRUG

abatacept

Intravenous infusion (500-1000 mg, dep on weight) at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks

DRUG

cyclophosphamide

500 mg intravenous infusion every 2 weeks for 12 weeks

DRUG

azathioprine

2 mg/kg/day orally from weeks 12-28; continue until week 52 if only partial response observed at week 24

DRUG

prednisone

60 mg/day for 2 weeks, then taper to 10 mg/day by 12 weeks, then continue on stable dose

DRUG

abatacept placebo

Intravenous infusion at weeks 0, 2, and 4, then every 4 weeks until week 24; continue to week 48 only if partial response at 24 weeks

DRUG

azathioprine placebo

Oral capsule, daily from weeks 28 to 52, only if complete response observed at week 24

Sponsors & Collaborators

• Immune Tolerance Network (ITN)

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• David Wofsy, MD · University of California, San Francisco

• Betty Diamond, MD · Feinstein Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-11-30

Primary Completion

2012-12-31

Completion

2014-06-30

Countries

• United States
• Mexico

Study Locations