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

This study has been terminated.
(The clinical use of Campath for transplant patients was temporarily suspended.)
Gruessner, Rainer, MD
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute Identifier:
First received: September 13, 2005
Last updated: February 5, 2013
Last verified: February 2013

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation

Resource links provided by NLM:

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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
Active Comparator: Group 2
Drug: Tacrolimus
Starting POD #1 0.06 mg/kg/day in 2 divided doses;
Experimental: Group 1
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:

  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

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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. -
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Please refer to this study by its identifier: NCT00177138

United States, Minnesota
University of Minnesota-Fairview
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Gruessner, Rainer, MD
Principal Investigator: Rainer W Gruessner, M.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute Identifier: NCT00177138     History of Changes
Other Study ID Numbers: 0308M51264
Berlex Study No. 107.G0001
Study First Received: September 13, 2005
Last Updated: February 5, 2013

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Campath Study
Pancreas After Kidney Transplantation

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Agents processed this record on May 25, 2017