Rituximab and Belimumab for Lupus Nephritis

Completed · Phase 2

Conditions studied: Lupus Nephritis

In brief

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 facts

Study ID

NCT02260934

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

43

Starts

2015-07-09

Expected to finish

2019-02-08

Last updated by the study team

2020-12-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria.
• Positive antinuclear antibody (ANA) or positive anti-ds DNA test results at visit -1 or any time within 14 days before visit -1.
• 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.
• Urine protein-to-creatinine ratio (UPCR) >1 at study entry based on a 24-hour collection.
• Ability to provide informed consent.

You may not qualify if…

• New onset lupus nephritis, defined as lupus nephritis for which the participant has not yet been treated with either mycophenolate mofetil or cyclophosphamide.
• Neutropenia (absolute neutrophil count <1500/mm\^3).
• Thrombocytopenia (platelets <50,000/mm\^3).
• Moderately severe anemia (Hgb < mg/dL).
• Moderately severe hypogammaglobulinemia (IgG <450 mg/dL) or Immunoglobulin A (IgA) <10mg/dL.
• Positive QuantiFERON -Tuberculosis (TB) Gold test results.
• Pulmonary fibrotic changes on chest radiograph consistent with prior healed tuberculosis.
• Active bacterial, viral, fungal, or opportunistic infections.
• Evidence of infection with human immunodeficiency virus (HIV), hepatitis B (as assessed by HBsAg and anti-HBc) or hepatitis C.
• Hospitalization for treatment of infections, or parenteral (IV or IM) antibacterials, antivirals, anti-fungals, or anti-parasitic agents within the past 60 days.
• Chronic infection that is currently being treated with suppressive antibiotic therapy, including but not limited to tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria.
• History of significant infection or recurrent infection that, in the investigator's opinion, places the participant at risk by participating in this study.
• Receipt of a live-attenuated vaccine within 3 months of study enrollment.
• End-stage renal disease (eGFR <20 mL/min/1.73m\^2).
• Concomitant malignancies or a history of malignancy, with the exception of adequately treated basal and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
• History of transplantation.
• History of primary immunodeficiency.
• Pregnancy.
• Breastfeeding.
• Unwillingness to use an FDA-approved form of birth control (including but not limited to a diaphragm, an intrauterine device, progesterone implants or injections, oral contraceptives, the double-barrier method, or a condom).
• Use of cyclophosphamide within the past 6 months.
• Use of anti-Tumor Necrosis Factor (TNF) medication, other biologic medications, or experimental non- biologic therapeutic agents within the past 90 days, or 5 half-lives prior to screening, whichever is greater.
• Intravenous immunoglobulin (IVIG), plasmapheresis, or leukopheresis within the past 90 days.
• Use of investigational biologic agent within the past 12 months.
• Prior treatment with rituximab, belimumab, atacicept, or other biologic B cell therapy.

Where it is running

• 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
• Columbia University Medical Center — New York, New York, United States
• University of North Carolina School of Medicine: — Chapel Hill, North Carolina, United States
• Ohio State University Wexner Medical Center: — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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