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

Not Applicable

Completed

• Conditions: Primary Renal Transplant
• Interventions: Drug: Calcineurin inhibitor withdrawal

• Registration Number: NCT00214201
• Lead Sponsor: University of Wisconsin, Madison

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 available

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2012-08-13
• Results First Submitted QC: 2012-08-13
• Status Verified: 2012-09
• Results First Posted: 2012-09-12
• Last Update Submitted: 2012-09-21
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Calcineurin inhibitor withdrawal	Calcineurin inhibitor withdrawal

Primary Outcome Measures

Name	Time	Method
Number of Participants With Biopsy Proven Rejection	3 years

Secondary Outcome Measures

Name	Time	Method
Serum Creatinine at 36 Months (End of Study)	36 months +/- 60 days

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States