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

Summary

The purpose of this study is to find out if the drug NULOJIX® (belatacept) will minimize the amount of other anti-rejection medications necessary and thereby reduce the long-term side effects caused by the other medications. The researchers also want to learn more about the safety of this treatment and long term health of transplanted pancreases and kidneys.

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.

Sponsors & Collaborators

• Clinical Trials in Organ Transplantation

  collaborator NETWORK

• Rho Federal Systems Division, Inc.

  collaborator INDUSTRY

• Bristol-Myers Squibb

  collaborator INDUSTRY

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Kenneth Newell, MD, PhD · Emory University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-02-28

Primary Completion

2016-08-31

Completion

2016-08-31

Countries

• United States

Study Locations