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

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 I Phase II

MedlinePlus related topics:

Kidney Transplantation

ChemIDplus related topics:

Alemtuzumab Campath

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

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:	35
Study Start Date:	June 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Receiving transplant from living donor
First transplant

Exclusion Criteria:

Multi-organ transplant
Treatment with an investigational immunosuppressive drug within 6 weeks of study entry
Previous or current history of malignancies and/or lymphoma
High risk of recurrence in transplanted kidney

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167661

Contacts


Contact: Sharon M. Bartosh, MD	608-265-6020	smbartosh@wisc.edu

Locations


United States, Wisconsin
	University of Wisconsin Hospital and Clinics	Recruiting
	Madison, Wisconsin, United States, 53792
	Contact: Sharon M Bartosh, MD 608-265-6020 smbartosh@wisc.edu

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 ( Sharon M Bartosh, MD )
Study ID Numbers:	2003-0493
First Received:	September 11, 2005
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00167661
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:

living donor renal transplant recipient

Study placed in the following topic categories:

Alemtuzumab

Additional relevant MeSH terms:

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00167661