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

University of Wisconsin, Madison40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Renal Transplant

Interventions

Calcineurin inhibitor withdrawalDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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;

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Number of Participants With Biopsy Proven Rejection

Time frame: 3 years

Secondary Outcomes

Serum Creatinine at 36 Months (End of Study)

Time frame: 36 months +/- 60 days

Data from ClinicalTrials.gov

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