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

This study has suspended participant recruitment.
(Enrollment was temporarily suspended pending a protocol revision to change the study to observational vs. intervention.)
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00167661
First received: September 11, 2005
Last updated: June 22, 2012
Last verified: June 2012
History of Changes
  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
Renal Transplantation
 Drug: Campath-1H
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation

Resource links provided by NLM:

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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal function [ Time Frame: at 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Incidence of infection and malignancy [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Growth post-transplant [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Incidence of hypertension and hyperlipidemia [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: at 6, 12, and 24 months ] [ Designated as safety issue: No ]
  • Incidence of diabetes mellitus [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2004
Estimated Study Completion Date: May 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
campath
 Drug: Campath-1H
two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant

  Eligibility

Ages Eligible for Study:   18 Months to 19 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00167661     History of Changes
Other Study ID Numbers: 2003-0493
Study First Received: September 11, 2005
Last Updated: June 22, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Campath 1G
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013