Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation (TAESR)
Primary Purpose
End-stage Renal Failure, Graft Rejection
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Tacrolimus (Kidney transplant maintenance immunosuppression)
Kidney transplant maintenance immunosuppression
Sponsored by
About this trial
This is an interventional prevention trial for End-stage Renal Failure focused on measuring Kidney transplant, Rejection, Adherence, Quality of life
Eligibility Criteria
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
Sites / Locations
- West London Renal & Transplant Centre, Hammersmith Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prolonged-Release Tacrolimus
Standard-Release tacrolimus
Arm Description
Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy
Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy
Outcomes
Primary Outcome Measures
Patient Survival With a Functioning Graft
Secondary Outcome Measures
Rejection-free Patient Survival With a Functioning Graft
Patient-reported Quality of Life, and Medication Adherence
Full Information
NCT ID
NCT00807144
First Posted
December 10, 2008
Last Updated
August 26, 2021
Sponsor
Imperial College Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00807144
Brief Title
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 2008 (Actual)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
Study Type: Phase IV
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Failure, Graft Rejection
Keywords
Kidney transplant, Rejection, Adherence, Quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prolonged-Release Tacrolimus
Arm Type
Experimental
Arm Description
Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy
Arm Title
Standard-Release tacrolimus
Arm Type
Active Comparator
Arm Description
Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy
Intervention Type
Drug
Intervention Name(s)
Tacrolimus (Kidney transplant maintenance immunosuppression)
Other Intervention Name(s)
Prograf
Intervention Description
Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
Intervention Type
Drug
Intervention Name(s)
Kidney transplant maintenance immunosuppression
Other Intervention Name(s)
Advagraf
Intervention Description
Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml
Primary Outcome Measure Information:
Title
Patient Survival With a Functioning Graft
Time Frame
One year post kidney transplantation
Secondary Outcome Measure Information:
Title
Rejection-free Patient Survival With a Functioning Graft
Time Frame
One and two years post kidney transplantation
Title
Patient-reported Quality of Life, and Medication Adherence
Time Frame
3,6,& 12 months post kidney transplant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam G McLean, MA DPhil
Organizational Affiliation
Imperial College Kidney & Transplant Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
West London Renal & Transplant Centre, Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://atcmeetingabstracts.com/abstract/1-year-outcomes-of-a-prospective-open-label-randomized-controlled-trial-of-standard-vs-extended-release-tacrolimus-as-maintenance-monotherapy-in-kidney-transplantation-after-alemtuzumab-induction-w
Description
Conference abstract
Learn more about this trial
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
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