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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-000889-22-GB
Enrollment
100
Registered
2008-10-03
Start date
2008-11-11
Completion date
Unknown
Last updated
2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of allograft rejection after renal transplantation MedDRA version: 9.1 Level: LLT Classification code 10023439 Term: Kidney transplant rejection

Interventions

Trade Name: Prograf Pharmaceutical Form: Capsule, hard Trade Name: Advagraf Pharmaceutical Form: Capsule, hard

Sponsors

Imperial College Healthcare NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. 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.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026