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Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation

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ClinicalTrials.gov Identifier: NCT00167661
Recruitment Status : Terminated (Enrollment suspended pending protocol revision to change study to observational)
First Posted : September 14, 2005
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.

Condition or disease Intervention/treatment Phase
Disorder Related to Renal Transplantation Drug: Campath-1H Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation
Study Start Date : June 2004
Actual Primary Completion Date : December 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Campath 1-H
Drug: Campath-1H
two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant
Other Name: Alemtuzumab



Primary Outcome Measures :
  1. The incidence of graft rejection and graft loss [ Time Frame: at 1, 3, 6, 12, and 24 months ]

Secondary Outcome Measures :
  1. Renal function [ Time Frame: at 3, 6, 12 and 24 months ]
  2. Incidence of infection and malignancy [ Time Frame: throughout study ]
  3. Growth post-transplant [ Time Frame: end of study ]
  4. Incidence of hypertension and hyperlipidemia [ Time Frame: throughout study ]
  5. Survival [ Time Frame: at 6, 12, and 24 months ]
  6. Incidence of diabetes mellitus [ Time Frame: throughout study ]


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Ages Eligible for Study:   18 Months to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects, aged 18 months - 18 years inclusive.
  2. Subjects must be a single-organ recipient (kidney only).
  3. Subjects who are receiving their first living donor or deceased donor transplant.

Exclusion Criteria:

  • 1. Subjects who are recipients of HLA-identical living-donor renal transplants. 2. Subjects with a PRA value > 10% within 30 days prior to the transplant. 3. Subjects who have received a multi-organ transplant. 4. Subjects who are who are positive for hepatitis C, hepatitis B surface antigen or HIV.

    5. Subjects who have received an investigational drug within 6 weeks of study entry.

    6. Subjects who have a previous history of, or who currently have, malignancies and/or lymphoma.

    7. Subjects who have received corticosteroids within three months of transplantation.

    8. Subjects who are 3rd transplant recipients. 9. Female subjects who are pregnant or lactating. Fertile female subjects who are sexually active must agree to use an acceptable method of birth control during the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167661


Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Study Chair: Sharon M Bartosh, MD University of Wisconsin, Madison
Principal Investigator: Sharon M Bartosh, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00167661     History of Changes
Other Study ID Numbers: 2011-0661 (2003-0493)
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by University of Wisconsin, Madison:
living or deceased donor renal transplant recipient

Additional relevant MeSH terms:
Alemtuzumab
Antineoplastic Agents