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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00177138
Recruitment Status : Terminated (The clinical use of Campath for transplant patients was temporarily suspended.)
First Posted : September 15, 2005
Last Update Posted : February 7, 2013
Gruessner, Rainer, MD
Information provided by (Responsible Party):
University of Minnesota

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Tacrolimus Drug: Alemtuzumab Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
Study Start Date : July 2004
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00177138

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United States, Minnesota
University of Minnesota-Fairview
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota
Gruessner, Rainer, MD
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Principal Investigator: Rainer W Gruessner, M.D. University of Minnesota
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Responsible Party: University of Minnesota Identifier: NCT00177138    
Other Study ID Numbers: 0308M51264
Berlex Study No. 107.G0001
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013
Keywords provided by University of Minnesota:
Campath Study
Pancreas After Kidney Transplantation
Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents