Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation

Graft Rejection Clinical Trial

— TAESR  

Official title:

A Phase-IV Study Comparing Standard Release Tacrolimus (Prograf) vs Prolonged-release Tacrolimus (Advagraf) Monotherapy as Maintenance Immunosuppression After Induction With Alemtuzumab in Kidney Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807144
• Other study ID #: ICKTI08TX02
• Secondary ID: 2008-000889-22
• Status: Completed
• Phase: Phase 4
• Start date: December 2008
• Est. completion date: March 2012

Study information

• Verified date: August 2021
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current anti-rejection drug regime for kidney transplant recipients in use at the West London Renal & Transplant Centre (WLRaTC) consists of induction therapy with the very potent monoclonal antibody Campath 1-H (Alemtuzumab) followed by long-term maintenance with the Calcineurin inhibitor Tacrolimus

The recent development (and licensing in the UK) of an extended-release, once daily formulation of Tacrolimus holds out the promise of simpler drug regimes for our patients. In the context of our current successful use of Tacrolimus monotherapy maintenance after Campath 1-H induction, the extended-release Tacrolimus formulation will enable us to offer a regime where the only long-term immunosuppressive treatment that most of our patients need will be a single drug, taken once a day.

The investigators wish to assess the efficacy of such a regime in a structured comparison with our current protocol.

Description:

1. Purpose of Study:

The current immunosuppressive regime used as anti-rejection therapy after kidney transplantation in the West London Renal & Transplant Centre at Imperial College Healthcare NHS Trust consists of induction therapy with Campath 1-H(Alemtuzumab) and a 1 week course of steroids followed by maintenance mono-therapy with standard-release (twice daily) Tacrolimus (Prograf). This study is designed to compare the costs and outcomes of this regime with one in which extended-release (once daily) Tacrolimus (Advagraf) is used in place of the standard-release Tacrolimus.

2. Study Type: Phase IV

3. Study Design: Prospective, randomised, controlled, open study. Patients will be randomized 1:1 between the standard and extended-release Tacrolimus arms.

Study entry will be stratified by live donor vs deceased donor transplants. The total recruitment target is 100 patients (50 standard release/50 extended release).

4. Study Description:

Patients will be randomised to receive either Prograf or Advagraf prior to transplantation.

Other than through the taking of extra blood samples at the time of routine clinical visits, participants will receive identical in-patient and out-patient management to patients undergoing kidney transplantation under our standard protocol.

Patients in the study will be asked to complete a short Health-Related Quality of Life questionnaire (SF-36) before transplantation and at 1 year post transplant. They will also be asked to complete a Medication Adherence Rating Score at 3, 6, and 12 months post-transplant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Live donor kidney transplant recipients

• heart-beating-Deceased donor kidney transplant recipients

• Patients suitable for induction therapy with Alemtuzumab

Exclusion Criteria:

• Recipients of Non-heart-beating deceased donor kidney transplants

• Recipients of simultaneous kidney/pancreas transplants

• ABO incompatible/desensitized transplant recipients

• Positive flow cross-match/desensitized transplant recipients

• Patients with heavy prior exposure to myelosuppressive therapy

• Patients with previous malignancy

• Patients with HIV,Hepatitis-C, or Hepatitis-B infection

Related Conditions & MeSH terms

• End-stage Renal Failure
• Graft Rejection
• Kidney Failure, Chronic

Intervention

Drug:
• Tacrolimus (Kidney transplant maintenance immunosuppression)
Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
• Kidney transplant maintenance immunosuppression
Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml

Locations

Country	Name	City	State
United Kingdom	West London Renal & Transplant Centre, Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Survival With a Functioning Graft		One year post kidney transplantation
Secondary	Rejection-free Patient Survival With a Functioning Graft		One and two years post kidney transplantation
Secondary	Patient-reported Quality of Life, and Medication Adherence		3,6,& 12 months post kidney transplant

External Links

•   Conference abstract