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

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.

Study Overview

• Status: Terminated
• Conditions: Disorder Related to Renal Transplantation
• Intervention / Treatment: Drug: Campath-1H

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants must be a single-organ recipient (kidney only)
• Participants who are receiving their first living donor or deceased donor transplant

Exclusion Criteria:

• Participants who are recipients of HLA-identical living-donor renal transplants
• Participants with a PRA value > 10% within 30 days prior to the transplant
• Participants who have received a multi-organ transplant
• Participants who are who are positive for hepatitis C, hepatitis B surface antigen or HIV
• Participants who have received an investigational drug within 6 weeks of study entry
• Participants who have a previous history of, or who currently have, malignancies and/or lymphoma
• Participants who have received corticosteroids within three months of transplantation
• Participants who are 3rd transplant recipients
• Female participants who are pregnant or lactating. Fertile female participants who are sexually active must agree to use an acceptable method of birth control during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 Names: Alemtuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Graft Rejection	at 1, 3, 6, 12, and 24 months
Participant Graft Survival	at 6, 12, and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated Glomerular Filtration Rate (EGFR)	Measure of renal function	at 1, 6, 12 and 24 months
Number of Participants With Infection	Cytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK)	up to 24 months
Number of Participants With Malignancy		up to 24 months
Growth Post-transplant Reported by Height Z Score	A z-score (aka, a standard score) indicates how many standard deviations an element is from the mean, in this case, height. A score of '0' is equal to the mean, a score less than 0 is less than the mean, and a score greater than 0 is greater than the mean.	up to 24 months
Number of Participants With Hypertension		up to 24 months
Number of Participants With Hyperlipidemia		up to 24 months
Participant Survival		at 6, 12, and 24 months
Number of Participant With Diabetes Mellitus		up to 24 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Sharon M Bartosh, MD, University of Wisconsin, Madison; Study Chair: Sharon M Bartosh, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 11, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 14, 2005

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: living or deceased donor renal transplant recipient
• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Alemtuzumab
• Other Study ID Numbers: 2011-0661; SMPH/PEDIATRICS/PEDIATRICS (Other Identifier: UW Madison); H-2003-0493 (Other Identifier: UW IRB); A536758 (Other Identifier: UW Madison)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No