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

Phase 1

Terminated

• Conditions: Disorder Related to Renal Transplantation
• Interventions: Drug: Campath-1H

• Registration Number: NCT00167661
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-14
• Primary Completion: 2011-12
• Study Completion: 2012-05
• Status Verified: 2020-08
• Results First Submitted: 2020-08-31
• Results First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Results First Posted: 2020-09-21
• Last Update Posted: 2020-09-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Campath 1-H	Campath-1H	Campath 1-H

Primary Outcome Measures

Name	Time	Method
Participant Graft Survival	at 6, 12, and 24 months
Incidence of Graft Rejection	at 1, 3, 6, 12, and 24 months

Secondary Outcome Measures

Name	Time	Method
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
Estimated Glomerular Filtration Rate (EGFR)	at 1, 6, 12 and 24 months	Measure of renal function
Number of Participants With Infection	up to 24 months	Cytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK)
Number of Participants With Malignancy	up to 24 months
Growth Post-transplant Reported by Height Z Score	up to 24 months	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.

Trial Locations

Locations (1)

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States