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

NCT ID: NCT00214201

Last Updated: 2012-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2009-05-31

Brief Summary

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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

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Conditions

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Primary Renal Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard of Care CNI immunosuppression

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Calcineurin inhibitor withdrawal

Group Type EXPERIMENTAL

Calcineurin inhibitor withdrawal

Intervention Type DRUG

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

Interventions

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Calcineurin inhibitor withdrawal

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

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stuart Knechtle, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2003-125

Identifier Type: -

Identifier Source: org_study_id