Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214201
First received: September 13, 2005
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to determine whether Campath-1H induction therapy and the associated lymphocyte depletion will permit long-term, rejection free renal allograft function in the absence of maintenance calcineurin inhibitor (CI) therapy.


Condition Intervention
Primary Renal Transplant
Drug: Calcineurin inhibitor withdrawal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Number of Participants With Biopsy Proven Rejection [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Serum Creatinine at 36 Months (End of Study) [ Time Frame: 36 months +/- 60 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • WBC [ Time Frame: 36 months +/- 60 days ] [ Designated as safety issue: No ]
    White Blood Cell count


Enrollment: 40
Study Start Date: May 2003
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Standard of Care CNI immunosuppression
Experimental: 2
Calcineurin inhibitor withdrawal
Drug: Calcineurin inhibitor withdrawal
stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • received a renal transplant, induction with Campath-1H, and at least 2 months of calcineurin inhibitor therapy, CellCept, and prednisone.

Exclusion Criteria:

  • Recipients of HLA-identical living-donor renal transplants;
  • PRA value >20% within 30 days of transplant;
  • GFR <40ml/min;
  • multi-organ transplant;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214201

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Stuart Knechtle, MD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214201     History of Changes
Other Study ID Numbers: 2003-125
Study First Received: September 13, 2005
Results First Received: August 13, 2012
Last Updated: September 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Campath 1G
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014