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

Renal Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365846
• Other study ID #: 2000-032
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2006
• Last updated: September 21, 2012
• Start date: August 2000
• Est. completion date: July 2006

Study information

• Verified date: September 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2006
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Renal Transplant

Intervention

Drug:
• Campath-1H

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

Barth RN, Janus CA, Lillesand CA, Radke NA, Pirsch JD, Becker BN, Fernandez LA, Thomas Chin L, Becker YT, Odorico JS, D'Alessandro AM, Sollinger HW, Knechtle SJ. Outcomes at 3 years of a prospective pilot study of Campath-1H and sirolimus immunosuppressio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Allograft Rejection		3 years	No
Secondary	Incidence of Severe Allograft Rejection ( Defined as >Banff 2A or Requiring Antibody Treatment)		3 years	No
Secondary	Patient Survival		3 years	Yes
Secondary	Incidence of Post-transplant Infection	Event of post-transplant infection (more than one "event" might have been counted per participant)	3 years	Yes
Secondary	Incidence of Malignancies	Number of Participants Experiencing Malignancies	3 years	Yes
Secondary	Kidney Allograft Survival		3 years	No