Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 9, 2016

Primary Completion Date

January 28, 2020

Study Completion Date

January 28, 2020

Conditions
Nephrotic SyndromeFocal Segmental GlomerulosclerosisMinimal Change Disease
Interventions
DRUG

Abatacept

Abatacept IV administered on Day 1, 15, 29 and then every 28 days

OTHER

Normal Saline

Normal Saline administer on Day 1, 15, 29 and then every 28 days

OTHER

D5W

Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days

Trial Locations (27)

10016

New York University Langone Medical Center, New York

10032

Columbia University Medical Center (Cumc), New York

15224

Local Institution, Pittsburgh

19104

University Of Pennsylvania, Philadelphia

20010

Children's National Health System, Washington D.C.

20892

NIH Clinical Center - NIDDK, Bethesda

27701

Duke University, Durham

28203

Levine Children's Hospital, Charlotte

32827

Nemours Childrens Hospital, Orlando

33136

University Of Miami Miller School Of Medicine, Miami

35233

The University Of Alabama At Birmingham, Birmingham

35294

University of Alabama-Birmingham-Parent Account, Birmingham

43210

The Ohio State University Wexner Medical Center, Columbus

44109

The Metro Health System, Cleveland

44195

Cleveland Clinic, Cleveland

48109

University of Michigan, Ann Arbor

55905

Mayo Clinic, Rochester

60153

Loyola University Medical Center, Maywood

64108

Childrens Mercy Hospital, Kansas City

75235

Renal Disease Research Institute, Dallas

75390

University Of Texas Southwestern Medical Center, Dallas

80045

University Of Colorado Denver, Aurora

90502

Los Angeles Biomedical Research Institute, Torrance

30322-1015

Emory University, Atlanta

02115

Boston Childrens Hospital, Boston

Brigham And Women'S Hosp Inc., Boston

45229-3039

Cincinnati Children'S Hospital Medical Center, Cincinnati

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY