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

NCT00167661 | Terminated Phase 1 Results DMC FDA Drug

• 4 other identifiers: 2011-0661H-2003-0493A536758SMPH/PEDIATRICS/PEDIATRICS
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder Related to Renal Transplantation

Keywords

living or deceased donor renal transplant recipient

Outcome Measures

Primary Outcomes (2)

• Incidence of Graft Rejection

  at 1, 3, 6, 12, and 24 months

• Participant Graft Survival

  at 6, 12, and 24 months

Secondary Outcomes (8)

• Estimated Glomerular Filtration Rate (EGFR)

  at 1, 6, 12 and 24 months

• Number of Participants With Infection

  up to 24 months

• Number of Participants With Malignancy

  up to 24 months

• Growth Post-transplant Reported by Height Z Score

  up to 24 months

• Number of Participants With Hypertension

  up to 24 months

Study Arms (1)

Campath 1-H

EXPERIMENTAL

Campath 1-H

Drug: Campath-1H

Interventions

Campath-1H DRUG

two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant

Also known as: Alemtuzumab

Campath 1-H

Eligibility Criteria

• Age: 18 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Alemtuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Sharon Bartosh
• Organization: University of Wisconsin - Madison

smbartosh@wisc.edu

(608) 265-6020

Study Officials

• Sharon M Bartosh, MD

  University of Wisconsin, Madison

  STUDY CHAIR

• Sharon M Bartosh, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 14, 2005
• Study Start: June 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2012
• Last Updated: September 21, 2020
• Results First Posted: September 21, 2020

Record last verified: 2020-08

Locations

US (1)