Efficacy of Islet After Kidney Transplantation

PHASE3CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

January 31, 2007

Primary Completion Date

July 31, 2015

Study Completion Date

July 5, 2017

Conditions
Type 1 Diabetes Mellitus
Interventions
PROCEDURE

Islet transplantation

BIOLOGICAL

Antithymocyte Globulin

Participants will begin receiving ATG 2 days prior to the initial islet transplant and will continue to receive ATG until Day 2 post-transplant.

BIOLOGICAL

Daclizumab or Basiliximab

Daclizumab or Basiliximab will be used for subsequent transplants.

BIOLOGICAL

Etanercept

Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.

BIOLOGICAL

Allogenic human purified pancreatic islets

200 ml suspension of allogenic human purified islets

Trial Locations (10)

19104

University of Pennsylvania, Philadelphia

30322

Emory Universtiy, Atlanta

33124

University of Miami, Miami

53792

University of Wisconsin, Madison

55455

University of Minnesota, Minneapolis

60208

Northwestern University, Chicago

60607

University of Illinois at Chicago, Chicago

94143

University of California, San Francisco, San Francisco

02114

Massachusetts General Hospital, Boston

T6G 2C8

University of Alberta, Edmonton

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00468117 - Efficacy of Islet After Kidney Transplantation | Biotech Hunter | Biotech Hunter