NCT02260934

Rituximab and Belimumab for Lupus Nephritis

Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis (ITN055AI)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lupus nephritis is a severe form of systemic lupus erythematosus (SLE) with active disease in the kidneys. SLE is a complex disease in which the body's own immune system attacks some of the body parts: the skin, the joints, the kidneys, the nervous system, the heart, the lungs and the blood. The cause of SLE is not known. Treatment for SLE usually involves drugs that are designed to block the immune system attacks. When SLE affects the kidneys (nephritis), stronger immune suppressing treatment is usually needed. The drugs used in treatment of lupus nephritis often do not cure the disease and can cause serious side effects, including lowering the immune system too much. When the immune system is too low, a person is at a higher risk of getting infections. Therefore, research into new treatments with fewer serious side effects is needed for lupus nephritis.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-07-09
• Primary completion: 2018-03-12
• Completion: 2019-02-08
• First posted: 2014-10-09
• Last updated: 2020-12-01
• Results posted: 2019-04-08

Locations

15 sites across 1 country: United States