Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
Information source: University of Minnesota
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus
Intervention: Tacrolimus (Drug); Alemtuzumab (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University of Minnesota Official(s) and/or principal investigator(s):
Rainer W Gruessner, M.D., Principal Investigator, Affiliation: University of Minnesota
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.
Clinical Details
Official title: Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time-to-event analysis will be used to analyze categorical end points that include graft failure, patient survival, biopsy documented rejection episode and non-compliance.
Secondary outcome: The continuous outcome variable, weekly or bi-weekly serum creatinine levels, will be analyzed using a two-way repeated-measures analysis of variance.
Detailed description:
Secondary objectives of the study are:
1. Compare the side effects of the immunosuppressive medications between both groups. This
will include anaphylactic reactions, GI side-effects, bone marrow suppression, renal
dysfunction, hypertension, hyperglycemic effects, and effects on lipid profile.
2. Compare the incidence of infections between both groups.
Comparison parameters are:
1. Pancreas and kidney graft failure
2. Patient death
3. Clinical and biopsy documented rejection episodes
4. Patient dropout (non-compliance with the study protocol)
5. Kidney function as assessed by creatinine clearance or biopsy
6. Need to change immunosuppression regimen
7. Quality-adjusted Life Years
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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. -
Locations and Contacts
University of Minnesota-Fairview, Minneapolis, Minnesota 55414, United States
Additional Information
Starting date: July 2004
Ending date: November 2006
Last updated: September 10, 2007
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