"A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation"

Phase 2

Completed

• Conditions: Renal Transplant
• Interventions: Drug: Campath-1H

• Registration Number: NCT00365846
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

The purpose of the study is to see if campath-1H can be used in first time renal transplant subjects to prevent rejection and reduce the overall amount of anti-rejection medications that patients take on a daily basis.

Detailed Description

Twenty nine primary recipients of either a live donor or deceased donor renal transplant were enrolled in this study. Subjects were administered two 20mg doses of Campath-1H antibody therapy (Day 0 and Day 1) in combination with a short course of corticosteroids, and maintenance sirolimus.

Subjects were followed for 3 years to compare the incidence and severity of rejection episodes, complications related to the immunosuppression, including infections, malignancies and adverse events. All subjects underwent protocol renal transplant biopsies at 6 and 12 months (unless medically contraindicated).

Study Timeline

• Study Start: 2000-08
• Primary Completion: 2005-07
• Study Completion: 2006-07
• Study First Submitted: 2006-08-16
• Study First Submitted QC: 2006-08-16
• Study First Posted: 2006-08-18
• Results First Submitted: 2012-06-22
• Results First Submitted QC: 2012-06-22
• Results First Posted: 2012-07-30
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-21
• Last Update Posted: 2012-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• primary renal transplant (not HLA identical)
• ages 18-60 years

Exclusion Criteria

• recipient panel reactive antibody level >10%
• recipient of a DCD kidney
• no prior organ transplant
• no multi-organ transplant recipient
• no subject who is currently receiving systemic corticosteroids
• no pregnant or lactating subjects
• no history of Hepatitis B, C or HIV positivity
• no recipient of a kidney with cold ischemia time >36 hours

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Campath 1H induction w/ Sirolimus immunosuppression	Campath-1H	Campath 1H at day -1 and 0 of kidney transplant followed by long term CNI free immunosuppressive therapy with Sirolimus,

Primary Outcome Measures

Name	Time	Method
Incidence of Allograft Rejection	3 years

Secondary Outcome Measures

Name	Time	Method
Patient Survival	3 years
Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)	3 years
Incidence of Post-transplant Infection	3 years	Event of post-transplant infection (more than one "event" might have been counted per participant)
Incidence of Malignancies	3 years	Number of Participants Experiencing Malignancies
Kidney Allograft Survival	3 years

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States