NCT03949855 - Belimumab With Rituximab for Primary Membranous Nephropathy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 6, 2020

Primary Completion Date

March 1, 2029

Study Completion Date

March 1, 2030

Conditions

Membranous NephropathyNephrotic Syndrome

Interventions

DRUG

Belimumab

"Belimumab is a recombinant, human, IgG1λ monoclonal antibody.~Belimumab will be provided as a 200 mg sterile, liquid product in a prefilled syringe. Each syringe contains 1.0 mL of 200 mg/mL belimumab. Each syringe will be a single use.~Standard Weekly dose:~Part A: 200 mg. administered subcutaneously. Part B: 400 mg (two 200 mg injections) from weeks 0-3, and then 200 mg from weeks 4-51, administered subcutaneously."

DRUG

Placebo for Belimumab

"The placebo control will be provided as a sterile liquid product in a prefilled syringe. Each syringe will be of a single use.~Standard weekly dose:~Part A: 200 mg. administered subcutaneously. Part B: 400 mg (two 200 mg injections) from weeks 0-3, and then 200 mg from weeks 4-51, administered subcutaneously."

DRUG

Rituximab

"Rituximab is a monoclonal antibody with specificity for CD20, a transmembrane protein expressed on B cells from the pre-B to memory cell development stages.~Rituximab is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-use vials for infusion. It is a clear, colorless liquid.~Dose: 1000 mg intravenously (IV), Week 4 and -6."

Trial Locations (20)

10032

RECRUITING

Columbia University Medical Center: Division of Nephrology, New York

19104

RECRUITING

University of Pennsylvania: Department of Medicine: Renal-Electrolyte and Hypertension Division, Philadelphia

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

21287

RECRUITING

Johns Hopkins, Baltimore

32224

RECRUITING

Mayo Clinic Jacksonville: Department of Nephrology and Hypertension, Jacksonville

33136

RECRUITING

University of Miami Miller School of Medicine, Div of Nephrology, Miami

35294

RECRUITING

University of Alabama at Birmingham School of Medicine: Division of Nephrology, Birmingham

43210

RECRUITING

Ohio State University Wexner Medical Center: Division of Nephrology, Columbus

44195

RECRUITING

Cleveland Clinic, Cleveland

48104

RECRUITING

University of Michigan, Ann Arbor

55455

RECRUITING

University of Minnesota Health Clinical Research Unit, Minneapolis

63110

RECRUITING

Washington University in St. Louis, St Louis

68198

RECRUITING

University of Nebraska, Omaha

72205

RECRUITING

University of Arkansas, Little Rock

80045

RECRUITING

University of Colorado, Aurora

90502

RECRUITING

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:Division of Nephrology and Hypertension, Torrance

94146

RECRUITING

University of California San Francisco, San Francisco

94305

RECRUITING

Stanford University School of Medicine: Division of Nephrology, Stanford

99204

RECRUITING

Providence Medical Research Center, Providence Health Care: Nephrology, Spokane

27599-

RECRUITING

University of North Carolina School of Medicine: Division of Nephrology and Hypertension, Kidney Center, Chapel Hill