"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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Alemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014