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

February 5, 2013 updated by: University of Minnesota

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 2
Tacrolimus/MMF/TMG
Drug: Tacrolimus
Starting POD #1 0.06 mg/kg/day in 2 divided doses;
Experimental: Group 1
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Bayer
Gruessner, Rainer, MD

Investigators

  • Principal Investigator: Rainer W Gruessner, M.D., University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0308M51264
  • Berlex Study No. 107.G0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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