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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00365846
Recruitment Status : Completed
First Posted : August 18, 2006
Results First Posted : July 30, 2012
Last Update Posted : October 3, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Renal Transplant Drug: Campath-1H Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2000
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Incidence of Allograft Rejection [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment) [ Time Frame: 3 years ]
  2. Patient Survival [ Time Frame: 3 years ]
  3. Incidence of Post-transplant Infection [ Time Frame: 3 years ]
    Event of post-transplant infection (more than one "event" might have been counted per participant)

  4. Incidence of Malignancies [ Time Frame: 3 years ]
    Number of Participants Experiencing Malignancies

  5. Kidney Allograft Survival [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00365846

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

Publications of Results:
Responsible Party: University of Wisconsin, Madison Identifier: NCT00365846     History of Changes
Other Study ID Numbers: 2000-032
First Posted: August 18, 2006    Key Record Dates
Results First Posted: July 30, 2012
Last Update Posted: October 3, 2012
Last Verified: September 2012

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

Additional relevant MeSH terms:
Antineoplastic Agents