Rituximab and Belimumab for Lupus Nephritis

Summary

In this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks.

Conditions

• Lupus Nephritis

Interventions

BIOLOGICAL

Rituximab

Rituximab 1000mg intravenously (IV) at week 0 and week 2

DRUG

Cyclophosphamide

Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.

DRUG

Prednisone

* Week 0 and Week 2: Prednisone (40 mg/day; taper to 10 mg/day by week 12) * Continue prednisone 10 mg/day to week 96

DRUG

Methylprednisolone

Week 0 and Week 2: Solumedrol (100 mg) IV

DRUG

Diphenhydramine

Diphenhydramine (50 mg, or equivalent dose of similar antihistamine) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.

DRUG

Acetaminophen

Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.

BIOLOGICAL

Rituximab

Rituximab 1000mg intravenously (IV) at week 0 and week 2.

DRUG

Cyclophosphamide

Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.

DRUG

Prednisone

* Week 0 and Week 2: Prednisone (40 mg/day; taper to 10 mg/day by week 12) * Continue prednisone 10 mg/day to week 96

DRUG

Methylprednisolone

Week 0 and Week 2: Solumedrol (100 mg) IV

DRUG

Diphenhydramine

Diphenhydramine (50 mg, or equivalent dose of similar antihistamine) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.

DRUG

Acetaminophen

Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.

BIOLOGICAL

Belimumab

The RCB Group will receive IV belimumab 10mg/kg at weeks 4, 6, 8, and then every 4 weeks through week 48

Sponsors & Collaborators

• Immune Tolerance Network (ITN)

  collaborator NETWORK

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Betty Diamond, M.D. · Feinstein Institute for Medical Research

• David Wofsy, M.D. · University of California San Francisco, Department of Medicine

• Maria Dall'Era, M.D. · University of California San Francisco, Department of Medicine

• Cynthia Aranow, M.D. · Feinstein Institute for Medical Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-09

Primary Completion

2018-03-12

Completion

2019-02-08

Countries

• United States

Study Locations