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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 21, 2012

Start Date ^ICMJE

May 2003

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

calcineurin inhibitor therapy

Change History

Complete list of historical versions of study NCT00214201 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

WBC [ Time Frame: 36 months +/- 60 days ] [ Designated as safety issue: No ]

White Blood Cell count

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Primary Renal Transplant

Intervention ^ICMJE

Drug: Calcineurin inhibitor withdrawal

stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy

Study Arm (s)

No Intervention: 1
Standard of Care CNI immunosuppression
Experimental: 2
Calcineurin inhibitor withdrawal

Intervention: Drug: Calcineurin inhibitor withdrawal

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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;

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00214201

Other Study ID Numbers ^ICMJE

2003-125

Has Data Monitoring Committee

Yes

Responsible Party

University of Wisconsin, Madison

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stuart Knechtle, MD

University of Wisconsin, Madison

Information Provided By

University of Wisconsin, Madison

Verification Date

September 2012

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

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