Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation - Full Text View

Sponsors and Collaborators:	University of Minnesota Bayer Gruessner, Rainer, MD
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00177138

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Tacrolimus Drug: Alemtuzumab	Phase IV

MedlinePlus related topics: Diabetes Kidney Transplantation

Drug Information available for: Tacrolimus Alemtuzumab Campath Tacrolimus anhydrous Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation

Further study details as provided by University of Minnesota:

Primary Outcome Measures:

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. [ Time Frame: 2 years ]

Secondary Outcome Measures:

The continuous outcome variable, weekly or bi-weekly serum creatinine levels, will be analyzed using a two-way repeated-measures analysis of variance. [ Time Frame: 2 years ]

Enrollment:	9
Study Start Date:	July 2004
Study Completion Date:	November 2006

Arms	Assigned Interventions
Group 2: Active Comparator Tacrolimus/MMF/TMG	Drug: Tacrolimus Starting POD #1 0.06 mg/kg/day in 2 divided doses;
Group 1: Experimental Campath/MMF/TMG	Drug: Alemtuzumab 30 mg IV intra-op and POD #12; then 30 mg IV >monthly for 1 year (only if ALC>200 mm, up to a total of 10 doses in year)

Detailed Description:

Secondary objectives of the study are:

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.
Compare the incidence of infections between both groups.

Comparison parameters are:

Pancreas and kidney graft failure
Patient death
Clinical and biopsy documented rejection episodes
Patient dropout (non-compliance with the study protocol)
Kidney function as assessed by creatinine clearance or biopsy
Need to change immunosuppression regimen
Quality-adjusted Life Years

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Previous kidney transplant from a living or deceased donor and a deceased- donor pancreas transplant.
Recipient age 18-60 years
Donor age 10-59 years
Females of childbearing potential should have a negative pregnancy test, and agree to practice birth control for the duration of the study.
Enteric or bladder drained pancreas transplant.

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Exclusion Criteria:

Use of an investigational drug in the last 1-year.
Positive T or B cell crossmatch.
WBC<3000 at enrollment
Platelet count <50,000 at enrollment
History of malignancy (exclusive of minor skin cancers)
Inability to give informed consent
Systemic infections
Major active or chronic infections, including documented HIV infection (by any licensed ELISA and confirmation by Western Blot).
Serology negative for EBV pre-transplant.
No other previous organ transplants other than pancreas and/or kidney. -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177138

Locations

United States, Minnesota
University of Minnesota-Fairview
Minneapolis, Minnesota, United States, 55414

Sponsors and Collaborators

University of Minnesota

Bayer

Gruessner, Rainer, MD

Investigators

Principal Investigator:

Rainer W Gruessner, M.D.

University of Minnesota

More Information

Study ID Numbers:	0308M51264, Berlex Study No. 107.G0001
Study First Received:	September 13, 2005
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00177138
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota:

Campath Study
Pancreas After Kidney Transplantation
Alemtuzumab

Study placed in the following topic categories:

Metabolic Diseases
Alemtuzumab
Diabetes Mellitus
Endocrine System Diseases
Tacrolimus

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Pancrelipase

Additional relevant MeSH terms:

Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009