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

This study has been terminated.
(Enrollment suspended pending protocol revision to change study to observational)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167661
First Posted: September 14, 2005
Last Update Posted: October 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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 Intervention Phase
Disorder Related to Renal Transplantation Drug: Campath-1H Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

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

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

Estimated Enrollment: 50
Study Start Date: June 2004
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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.

  Contacts and Locations
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
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00167661     History of Changes
Other Study ID Numbers: 2011-0661 (2003-0493)
First Submitted: September 11, 2005
First Posted: September 14, 2005
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