Skip to main content
OpenTrials
Completed

NCT Number: NCT00365846

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Transplant

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Campath-1H

Drug

Primary outcomes

  1. Incidence of Allograft Rejection

    Time frame: 3 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2005
Study completion
2006
First posted
Aug 18, 2006
Registry last updated
Oct 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.