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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00365846
First received: August 16, 2006
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Renal Transplant
Drug: Campath-1H
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: "A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52) Therapy in Primary Renal Allograft Transplantation

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Incidence of Allograft Rejection [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Patient Survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Incidence of Post-transplant Infection [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Event of post-transplant infection (more than one "event" might have been counted per participant)

  • Incidence of Malignancies [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Number of Participants Experiencing Malignancies

  • Kidney Allograft Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: August 2000
Study Completion Date: July 2006
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Campath 1H induction w/ Sirolimus immunosuppression
Campath 1H at day -1 and 0 of kidney transplant followed by long term CNI free immunosuppressive therapy with Sirolimus,
Drug: Campath-1H

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365846

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Stuart J Knechtle University of Wisconsin, Madison
  More Information

Publications:
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00365846     History of Changes
Other Study ID Numbers: 2000-032
Study First Received: August 16, 2006
Results First Received: June 22, 2012
Last Updated: September 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
prevent kidney rejection

Additional relevant MeSH terms:
Campath 1G
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014