Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients

PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

May 22, 2017

Primary Completion Date

December 11, 2020

Study Completion Date

May 18, 2021

Conditions
Kidney TransplantationPrimary Focal Segmental Glomerulosclerosis (FSGS)
Interventions
DRUG

Bleselumab

Intravenous infusion

DRUG

Basiliximab

Bolus injection

DRUG

Mycophenolate Mofetil (MMF)

Oral Intravenous

DRUG

Tacrolimus Capsules

Oral Capsule

DRUG

Methylprednisone

Oral or Intravenous

DRUG

Prednisone

Oral Tablet

Trial Locations (23)

10032

Columbia University Medical Center, New York

14215

Erie County Medical Center, Buffalo

19104

University of Pennsylvania Health System, PCAM, Philadelphia

22908

University of Virginia, Charlottesville

27710

Duke University Medical Center, Durham

27713

University of North Carolina, Chapel Hill

29425

Medical University of South Carolina, Charleston

33136

University of Miami, Miami

40202

University of Louisville, Louisville

46220

Indiana University, Indianapolis

48109

Michigan Medicine, Ann Arbor

60637

University of Chicago, Chicago

63110

Washington University in St. Louis, St Louis

70112

Tulane University Health Service Center, New Orleans

80045

University of Colorado, Aurora

84132

University of Utah Medical Center, Salt Lake City

85724

University of Arizona, Tucson

94143

UCSF, San Francisco

94304

Stanford School of Medicine, Palo Alto

07039

St. Barnabas, Livingston

TG6 2B7

Site CA15002, Edmonton

V6Z 1Y6

Site CA15005, Vancouver

H1T 2M4

Site CA15006, Montreal

All Listed Sponsors
collaborator

Kyowa Kirin Co., Ltd.

INDUSTRY

lead

Astellas Pharma Global Development, Inc.

INDUSTRY

NCT02921789 - Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients | Biotech Hunter | Biotech Hunter