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

This study is ongoing, but not recruiting participants.

First Received: September 13, 2005 Last Updated: December 17, 2007 History of Changes

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00214201

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

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Campath Alemtuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Campath-1H Induction to Allow Discontinuation of Calcineurin Inhibitors After Renal Transplantation

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

Primary Outcome Measures:

renal function [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

immunologic function [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	May 2003
Estimated Study Completion Date:	May 2009

Arms	Assigned Interventions
1: No Intervention
2: Experimental 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

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 ( Stuart Knechtle, MD )
Study ID Numbers:	2003-125
Study First Received:	September 13, 2005
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00214201 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cyclosporine
Alemtuzumab
Tacrolimus
Cyclosporins

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Alemtuzumab
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009