Overview

Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation

Status:
Terminated

Trial end date:
2006-11-01

Target enrollment:
0

Participant gender:
All

Summary

This is a single center, prospective, open-label, randomized trial at the University of Minnesota Medical Center,Fairview. Primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1) immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin, tacrolimus, and MMF (Group 2). This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Minnesota
University of Minnesota - Clinical and Translational Science Institute

Collaborators:

Bayer
Gruessner, Rainer, MD

Treatments:

Alemtuzumab
Pancreatin
Pancrelipase
Tacrolimus

Criteria

Inclusion Criteria:

1. Previous kidney transplant from a living or deceased donor and a deceased- donor
pancreas transplant.

2. Recipient age 18-60 years

3. Donor age 10-59 years

4. Females of childbearing potential should have a negative pregnancy test, and agree to
practice birth control for the duration of the study.

5. Enteric or bladder drained pancreas transplant.

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Exclusion Criteria:

1. Use of an investigational drug in the last 1-year.

2. Positive T or B cell crossmatch.

3. WBC<3000 at enrollment

4. Platelet count <50,000 at enrollment

5. History of malignancy (exclusive of minor skin cancers)

6. Inability to give informed consent

7. Systemic infections

8. Major active or chronic infections, including documented HIV infection (by any
licensed ELISA and confirmation by Western Blot).

9. Serology negative for EBV pre-transplant.

10. No other previous organ transplants other than pancreas and/or kidney. -