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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000889-22 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged-Release Tacrolimus | Experimental | Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy |
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| Standard-Release tacrolimus | Active Comparator | Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus (Kidney transplant maintenance immunosuppression) | Drug | Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival With a Functioning Graft | One year post kidney transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Rejection-free Patient Survival With a Functioning Graft | One and two years post kidney transplantation | |
| Patient-reported Quality of Life, and Medication Adherence | 3,6,& 12 months post kidney transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam G McLean, MA DPhil | Imperial College Kidney & Transplant Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West London Renal & Transplant Centre, Hammersmith Hospital | London | W12 0HS | United Kingdom |
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| Conference abstract | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Release Tacrolimus | Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml |
| FG001 | Standard Release Tacrolimus |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Kidney transplant maintenance immunosuppression | Drug | Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml |
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Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Release Tacrolimus | Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml |
| BG001 | Standard Release Tacrolimus | Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Patient Survival With a Functioning Graft | Posted | Number | percent of participants | One year post kidney transplantation |
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| Secondary | Rejection-free Patient Survival With a Functioning Graft | Posted | Number | percent of participants | One and two years post kidney transplantation |
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| Secondary | Patient-reported Quality of Life, and Medication Adherence | Data not collected | Posted | 3,6,& 12 months post kidney transplant |
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2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extended Release Tacrolimus | Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy Kidney transplant maintenance immunosuppression: Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml | 4 | 52 | 0 | 52 | 8 | 52 |
| EG001 | Standard Release Tacrolimus | Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy Tacrolimus (Kidney transplant maintenance immunosuppression): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml | 2 | 50 | 1 | 50 | 9 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver failure | Hepatobiliary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any rejection symptom | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam McLean | Imperial College Healthcare NHS Trust | +44 020 8383 5164 | adammclean@nhs.net |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Male |
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| Asian |
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| Caucasian |
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| Other |
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