End-stage Renal FailurePhase 4TAESRNCT00807144
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
A Phase 4 study testing Tacrolimus (Kidney transplant maintenance immunosuppression) and Kidney transplant maintenance immunosuppression in people with End-stage Renal Failure and Graft Rejection, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End-stage Renal Failure, Graft Rejection
- What is being tested?
- Tacrolimus (Kidney transplant maintenance immunosuppression) and Kidney transplant maintenance immunosuppression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2008to Mar 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Live donor kidney transplant recipients
- heart-beating-Deceased donor kidney transplant recipients
- Patients suitable for induction therapy with Alemtuzumab
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
West London Renal & Transplant Centre, Hammersmith Hospital
London, W12 0HS
About this study
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
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.
Read the 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.
- Conditions
- End-stage Renal Failure, Graft Rejection
- Being tested
- Tacrolimus (Kidney transplant maintenance immunosuppression), Kidney transplant maintenance immunosuppression
- Keywords
- Kidney transplant, Rejection, Adherence, Quality of life
- Medical subject headings
- Kidney Failure, Chronic, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus (Kidney transplant maintenance immunosuppression)Drug
Also called Prograf
Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
Kidney transplant maintenance immunosuppressionDrug
Also called Advagraf
Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml
| Study group | Role | What they receive |
|---|---|---|
| Prolonged-Release Tacrolimus | Experimental | Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy Receives: Drug: Kidney transplant maintenance immunosuppression |
| Standard-Release tacrolimus | Active comparator | Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy Receives: Drug: Tacrolimus (Kidney transplant maintenance immunosuppression) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Survival With a Functioning Graft
Measured: One year post kidney transplantation
Secondary outcomes (2)
Rejection-free Patient Survival With a Functioning Graft
Measured: One and two years post kidney transplantation
Patient-reported Quality of Life, and Medication Adherence
Measured: 3,6,& 12 months post kidney transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End-stage Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam G McLean, MA DPhil, Principal investigator, Imperial College Kidney & Transplant Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807144
- Sponsor's protocol ID
- ICKTI08TX02
- Other IDs
- 2008-000889-22, 2008
- Acronym
- TAESR
- Status last verified
- Aug 2021
- First submitted
- 10 Dec 2008
- Last updated
- 27 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00807144
- Acronym / sponsor ID
- TAESR / ICKTI08TX02
- Conditions
- End-stage Renal Failure, Graft Rejection
- Keywords
- Kidney transplant, Rejection, Adherence, Quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- Dec 2008 (actual)
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Dec 2008 (estimated)
- Results
- Posted 27 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged-Release Tacrolimus | Experimental | Drug: Kidney transplant maintenance immunosuppressionTransplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy |
| Standard-Release tacrolimus | Active comparator | Drug: Tacrolimus (Kidney transplant maintenance immunosuppression)Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Live donor kidney transplant recipients
- heart-beating-Deceased donor kidney transplant recipients
- Patients suitable for induction therapy with Alemtuzumab
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus (Kidney transplant maintenance immunosuppression)Also: PrografStandard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml | Drug | Standard-Release tacrolimus |
| Kidney transplant maintenance immunosuppressionAlso: AdvagrafProlonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml | Drug | Prolonged-Release Tacrolimus |
Primary outcome
Patient Survival With a Functioning Graft
Time frame: One year post kidney transplantation
2 secondary outcomes
Rejection-free Patient Survival With a Functioning Graft
Time frame: One and two years post kidney transplantation
Patient-reported Quality of Life, and Medication Adherence
Time frame: 3,6,& 12 months post kidney transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Conference abstractLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam G McLean, MA DPhil principal investigator
Imperial College Kidney & Transplant Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus (Kidney transplant maintenance immunosuppression) and Kidney transplant maintenance immunosuppression in people with End-stage Renal Failure and Graft Rejection, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Survival With a Functioning Graft (time frame: One year post kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.