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Rituximab and Belimumab for Lupus Nephritis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Rituximab and Belimumab for Lupus Nephritis

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

NCT02260934•National Institute of Allergy and Infectious Diseases (NIAID)

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria.
•2. Positive antinuclear antibody (ANA) or positive anti-ds DNA test results at visit -1 or any time within 14 days before visit -1.
•3. Active proliferative lupus nephritis, as defined by either of the following:
•* Kidney biopsy documentation within the last 3 months of International Society of Nephrology/Renal Pathology Society (ISN/RPS) proliferative nephritis: Class III, Class IV, or Class V in combination with Class III or IV.
•* Active urinary sediment and kidney biopsy documentation within the last 12 months of ISN/RPS proliferative nephritis: Class III, Class IV, or Class V in combination with Class III or IV. Active urinary sediment is defined as any one of the following:
•* \>5 RBC/hpf in the absence of menses and infection;
•* \>5 White blood cell per high powered field (WBC/hpf) in the absence of infection; or
•* Cellular casts limited to RBC or WBC casts.
•4. Urine protein-to-creatinine ratio (UPCR) \>1 at study entry based on a 24-hour collection.
•5. Ability to provide informed consent.

Exclusion Criteria

•1. New onset lupus nephritis, defined as lupus nephritis for which the participant has not yet been treated with either mycophenolate mofetil or cyclophosphamide.
•2. Neutropenia (absolute neutrophil count \<1500/mm\^3).
•3. Thrombocytopenia (platelets \<50,000/mm\^3).
•4. Moderately severe anemia (Hgb \< mg/dL).
•5. Moderately severe hypogammaglobulinemia (IgG \<450 mg/dL) or Immunoglobulin A (IgA) \<10mg/dL.
•6. Positive QuantiFERON -Tuberculosis (TB) Gold test results.
•7. Pulmonary fibrotic changes on chest radiograph consistent with prior healed tuberculosis.
•8. Active bacterial, viral, fungal, or opportunistic infections.
•9. Evidence of infection with human immunodeficiency virus (HIV), hepatitis B (as assessed by HBsAg and anti-HBc) or hepatitis C.
•10. Hospitalization for treatment of infections, or parenteral (IV or IM) antibacterials, antivirals, anti-fungals, or anti-parasitic agents within the past 60 days.
+25 more criteria

Locations (15)

University of Alabama, Birmingham

Birmingham, Alabama, United States

UCLA Medical Center: Division of Rheumatology

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado Denver: School of Medicine: Division of Rheumatology

Aurora, Colorado, United States

Colorado Kidney Care

Denver, Colorado, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Washington University in St. Louis

St Louis, Missouri, United States

Feinstein Institute, North Shore Hospital

Manhasset, New York, United States

New York University, Langone Medical Center

New York, New York, United States

Weill Cornell Medical College: Hospital for Special Surgery -

New York, New York, United States

Key Dates

Start Date

July 9, 2015

Primary Completion Date

March 12, 2018

Completion Date

February 8, 2019

Last Updated

December 1, 2020

Enrollment

ACTUAL participants

Conditions

Lupus Nephritis

Interventions

Rituximab

BIOLOGICAL

Cyclophosphamide

DRUG

Prednisone

DRUG

Methylprednisolone

DRUG

Diphenhydramine

DRUG

Acetaminophen

DRUG

Rituximab

BIOLOGICAL

Cyclophosphamide

DRUG

Prednisone

DRUG

Methylprednisolone

DRUG

Diphenhydramine

DRUG

Acetaminophen

DRUG

Belimumab

BIOLOGICAL

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

NCT05126277

Lupus Nephritis

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RECRUITINGPHASE2

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

NCT07015983

Lupus Erythematosus, SystemicLupus Nephritis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Rituximab and Belimumab for Lupus Nephritis

Inclusion Criteria

Exclusion Criteria

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

Safety and Efficacy of ONT01 in Lupus

Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial

Lupus Landmark Study: A Prospective Registry and Biorepository