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

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Renal Transplant

Treatments: Drug: Campath-1H

Study type: Interventional

Funder types: Other

Identifiers

NCT00365846

2000-032

Details and patient eligibility

About

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.

Full 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).

Enrollment: 29 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Campath 1H induction w/ Sirolimus immunosuppression

Experimental group

Description:

Campath 1H at day -1 and 0 of kidney transplant followed by long term CNI free immunosuppressive therapy with Sirolimus,

Treatment:

Drug: Campath-1H