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


Phase 2
18 Years
60 Years
Not Enrolling
Both
Renal Transplant

Thank you

Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence of Allograft Rejection

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Stuart J Knechtle

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Food and Drug Administration

Study ID:

2000-032

NCT ID:

NCT00365846

Start Date:

August 2000

Completion Date:

July 2006

Related Keywords:

  • Renal Transplant
  • prevent kidney rejection

Name

Location
University of Wisconsin Madison,, Wisconsin  53792-5666