A randomised controlled comparison of standard release Tacrolimus vs extended-release Tacrolimus as baseline maintenance monotherapy for kidney transplantation after induction with Campath 1-H. - TAESR

Phase 1

• Conditions: Prevention of allograft rejection after renal transplantation; MedDRA version: 9.1Level: LLTClassification code 10023439Term: Kidney transplant rejection

• Registration Number: EUCTR2008-000889-22-GB
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-03
• Study Completion: 2012-03-29
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Adults undergoing live donor or deceased donor kidney transplantation who are able to give written informed consent to the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Patients who would not be treated with Campath 1-H under current renal unit protocols:
a. Patents with prior exposure to potent anti-proliferative or myelosuppressive agents.
b. Patients with previous malignancy.
c. Patients with chronic hepatitis B hepatitis C or HIV infection.
2. Patients receiving non-heart-beating deceased donor kidney transplants.
3. Patients receiving simultaneous kidney/pancreas transplants.
4. Patients undergoing desensitization for ABO incompatible or positive cross-match transplantation
5. Women of child-bearing age who would not be treated with Alemtuzumab because they are unable or unwilling to use effective contraception during therapy and continue its use for 6 months following the last dose of Alemtuzumab.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare outcomes of kidney transplantation after induction with Alemtuzumab/short course steroids, followed by maintenance with either standard release Tacrolimus (Prograf) monotherapy, or extended-release tacrolimus (Advagraf) monotherapy.<br><br>Primary outcome measures: Survival with a functioning graft at 1 year and 3 years.;Secondary Objective: Secondary outcomes: Rejection rate / Time to achievement of target Tacrolimus levels / Inter-visit variance in Tacrolimus trough level / Lymphocyte subset recovery rates after Campath / Donor-specific ?-IFN producing lymphocyte frequency and phenotype / Functional Calcineurin inhibition levels.;Primary end point(s): Survival with a functioning graft at 1 and 3 years.