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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.)
Sponsor:
Collaborators:
Bayer
Gruessner, Rainer, MD
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00177138
First received: September 13, 2005
Last updated: February 5, 2013
Last verified: February 2013

September 13, 2005
February 5, 2013
July 2004
Not Provided
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 ]
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.
Complete list of historical versions of study NCT00177138 on ClinicalTrials.gov Archive Site
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 ]
The continuous outcome variable, weeily or bi-weekly serum creatinine levels, will be analyzed using a two-way repeated-measures analysis of variance.
Not Provided
Not Provided
 
Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: Tacrolimus
    Starting POD #1 0.06 mg/kg/day in 2 divided doses;
  • 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)
  • Active Comparator: Group 2
    Tacrolimus/MMF/TMG
    Intervention: Drug: Tacrolimus
  • Experimental: Group 1
    Campath/MMF/TMG
    Intervention: Drug: Alemtuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
November 2006
Not Provided

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. -
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00177138
0308M51264, Berlex Study No. 107.G0001
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
  • Bayer
  • Gruessner, Rainer, MD
Principal Investigator: Rainer W Gruessner, M.D. University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP