Rituximab and Belimumab for Lupus Nephritis

Conditions

• Lupus Nephritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab — BIOLOGICAL
  Rituximab 1000mg intravenously (IV) at week 0 and week 2
• Cyclophosphamide — DRUG
  Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.
• Prednisone — DRUG
  * 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
• Methylprednisolone — DRUG
  Week 0 and Week 2: Solumedrol (100 mg) IV
• Diphenhydramine — DRUG
  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.
• Acetaminophen — DRUG
  Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
• Rituximab — BIOLOGICAL
  Rituximab 1000mg intravenously (IV) at week 0 and week 2.
• Cyclophosphamide — DRUG
  Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.
• Prednisone — DRUG
  * 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
• Methylprednisolone — DRUG
  Week 0 and Week 2: Solumedrol (100 mg) IV
• Diphenhydramine — DRUG
  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.
• Acetaminophen — DRUG
  Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
• Belimumab — BIOLOGICAL
  The RCB Group will receive IV belimumab 10mg/kg at weeks 4, 6, 8, and then every 4 weeks through week 48

Study Details

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.

Key Dates

Start date

Jul 9, 2015

Status verified

Nov 2020

Primary completion

Mar 12, 2018

Completion

Feb 8, 2019

Study Design

Enrollment

43 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Rituximab/Cyclophosphamide (RC)
  Prednisone taper to 10 mg/day by week 12 and continue prednisone 10 mg/day to week 96.
• Experimental: Rituximab/Cyclophosphamide/Belimumab (RCB)
  1. Belimumab (10 mg/kg IV) at weeks 4, 6, 8, and every 4 weeks to week 48. 2. Prednisone taper to 10 mg/day by week 12, and continue prednisone 10 mg/day to week 96.

Primary Outcome Measure

Percentage of Participants With At Least One Grade 3 or Higher Infectious Adverse Event By Week 24, Week 48 and Week 96 [ Time Frame: Week 0 to Week 96 ]

Locations (15)

Find similar trials in Birmingham, AL

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