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

University of Wisconsin (UW)

Status: Completed

Conditions: Primary Renal Transplant

Treatments: Drug: Calcineurin inhibitor withdrawal

Study type: Interventional

Funder types: Other

Identifiers

NCT00214201

2003-125

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

No Intervention group

Description:

Standard of Care CNI immunosuppression

2

Experimental group

Description:

Calcineurin inhibitor withdrawal

Treatment:

Drug: Calcineurin inhibitor withdrawal