Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation

PHASE2TerminatedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Simultaneous Kidney and Pancreas Transplantation
Interventions
BIOLOGICAL

Belatacept

The first dose of belatacept will be administered approximately 24-48 hours after the last dose of Anti-Thymocyte Globulin (Rabbit).

DRUG

methylprednisolone

BIOLOGICAL

Anti-thymocyte Globulin (Rabbit)

DRUG

Tacrolimus

There may be an opportunity to withdraw tacrolimus at week 40

DRUG

Mycophenolate mofetil

Mycophenolate mofetil will be administered at a target dose of 1000 mg by mouth twice daily (e.g., BID) beginning on the day of surgery or post-operative day 1 depending upon when during the day the surgery is completed (maximum MMF dosing is 2G per day). MMF will be adjusted based on clinical complications (such as neutropenia). Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.

Trial Locations (5)

30322

Emory University, Atlanta

35294

University of Alabama at Birmingham, Birmingham

46202

Indiana University Hospital, Indianapolis

53792

University of Wisconsin, Madison

94143-0780

University of California San Francisco Medical Center, San Francisco

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Clinical Trials in Organ Transplantation

NETWORK

collaborator

Rho Federal Systems Division, Inc.

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH