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"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"

NCT ID: NCT00365846

Last Updated: 2012-10-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2006-07-31

Brief Summary

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The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.

Detailed Description

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Twenty nine primary recipients of either a live donor or deceased donor renal transplant were enrolled in this study. Subjects were administered two 20mg doses of Campath-1H antibody therapy (Day 0 and Day 1) in combination with a short course of corticosteroids, and maintenance sirolimus.

Subjects were followed for 3 years to compare the incidence and severity of rejection episodes, complications related to the immunosuppression, including infections, malignancies and adverse events. All subjects underwent protocol renal transplant biopsies at 6 and 12 months (unless medically contraindicated).

Conditions

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Renal Transplant

Keywords

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prevent kidney rejection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Campath 1H induction w/ Sirolimus immunosuppression

Campath 1H at day -1 and 0 of kidney transplant followed by long term CNI free immunosuppressive therapy with Sirolimus,

Group Type EXPERIMENTAL

Campath-1H

Intervention Type DRUG

Interventions

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Campath-1H

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* primary renal transplant (not HLA identical)
* ages 18-60 years

Exclusion Criteria

* recipient panel reactive antibody level \>10%
* recipient of a DCD kidney
* no prior organ transplant
* no multi-organ transplant recipient
* no subject who is currently receiving systemic corticosteroids
* no pregnant or lactating subjects
* no history of Hepatitis B, C or HIV positivity
* no recipient of a kidney with cold ischemia time \>36 hours
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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 J Knechtle

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

References

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Barth RN, Janus CA, Lillesand CA, Radke NA, Pirsch JD, Becker BN, Fernandez LA, Thomas Chin L, Becker YT, Odorico JS, D'Alessandro AM, Sollinger HW, Knechtle SJ. Outcomes at 3 years of a prospective pilot study of Campath-1H and sirolimus immunosuppression for renal transplantation. Transpl Int. 2006 Nov;19(11):885-92. doi: 10.1111/j.1432-2277.2006.00388.x.

Reference Type RESULT
PMID: 17018123 (View on PubMed)

Fehr T, Hubel K, de Rougemont O, Abela I, Gaspert A, Gungor T, Hauri M, Helmchen B, Linsenmeier C, Muller T, Nilsson J, Riesterer O, Scandling JD, Schanz U, Cippa PE. Successful Induction of Specific Immunological Tolerance by Combined Kidney and Hematopoietic Stem Cell Transplantation in HLA-Identical Siblings. Front Immunol. 2022 Jan 31;13:796456. doi: 10.3389/fimmu.2022.796456. eCollection 2022.

Reference Type DERIVED
PMID: 35173720 (View on PubMed)

Other Identifiers

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2000-032

Identifier Type: -

Identifier Source: org_study_id