Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008553-27 | EudraCT Number | ||
| ISRCTN88894088 | Registry Identifier | ISRCTN |
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| Name | Class |
|---|---|
| National Health Service, United Kingdom | OTHER_GOV |
| Pfizer | INDUSTRY |
| Novartis | INDUSTRY |
Not provided
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The 3C study is investigating whether reducing exposure to calcineurin inhibitors (by using more potent antibody induction treatment and/or an elective switch to sirolimus) can improve the function and survival of kidney transplants.
The long-term survival of kidney transplants has not improved over the past decade despite reductions in the rate of acute rejection. The commonest cause of late graft loss is chronic allograft nephropathy which is frequently caused by calcineurin inhibitor toxicity. Therefore, it may be possible to improve long-term graft outcomes by reducing the amount of calcineurin inhibitor exposure.
Two possible strategies to do this were tested. Firstly, Campath-1H (a monoclonal lymphocyte-depleting antibody) was compared to standard basiliximab-based induction. All patients then received tacrolimus-based maintenance therapy for 6-months (using lower doses in the Campath-1H arm).
At six months, patients were re-randomized between remaining on tacrolimus and converting to sirolimus (and therefore no longer taking calcineurin inhibitors). Patients were then followed-up in clinic and through routine NHS registries to collect information on relevant outcomes (including graft function, survival, hospitalisations and death).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alemtuzumab/Sirolimus | Experimental | Induction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Sirolimus |
|
| Alemtuzumab/Tacrolimus | Experimental | Induction therapy allocation: Alemtuzumab (Campath-1H). Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus |
|
| Basiliximab/Tacrolimus | Active Comparator | Induction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Tacrolimus |
|
| Basiliximab/Sirolimus | Active Comparator | Induction therapy allocation: Basiliximab. Maintenance therapy allocation (at 6-months post-transplant): Sirolimus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alemtuzumab | Drug | Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy | Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus)) | 6 months post-transplantation |
| Graft Function (at 18-months After Randomization to Maintenance Therapy) | Estimated glomerular filtration rate (estimated using MDRD formula) at 18-months after maintenance therapy randomization to either Sirolimus or Tacrolimus. | 2 years post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy) | Return to dialysis or re-transplantation by 6-months after randomization to induction therapy. | 6 months post-transplantation |
| Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Friend | University of Oxford | Study Director |
| Colin Baigent | University of Oxford | Principal Investigator |
| Martin J Landray | University of Oxford | Principal Investigator |
| Paul Harden | University of Oxford | Principal Investigator |
| Richard Haynes | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Radcliffe Hospitals NHS Trust | Oxford | Oxon | OX3 7LJ | United Kingdom | ||
| University Hospitals Birmingham NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25078310 | Result | 3C Study Collaborative Group; Haynes R, Harden P, Judge P, Blackwell L, Emberson J, Landray MJ, Baigent C, Friend PJ. Alemtuzumab-based induction treatment versus basiliximab-based induction treatment in kidney transplantation (the 3C Study): a randomised trial. Lancet. 2014 Nov 8;384(9955):1684-90. doi: 10.1016/S0140-6736(14)61095-3. Epub 2014 Jul 28. | |
| 29226570 |
| Label | URL |
|---|---|
| 3C study website | View source |
Not provided
Proposals for substudies must be approved by the Steering Committee. Procedure for accessing the data for this study are available on https://www.ndph.ox.ac.uk/data-access
Not provided
See URL
852 participants were randomized for a comparison of Alemtuzumab (426) and Basiliximab (426) based induction therapies. After 6-months, 394 of those participants were re-randomized to either Sirolimus (197) or Tacrolimus (197) based maintenance therapies.
3C was conducted in 18 transplant centres in the UK. Recruitment took place between October 2010 and July 2013.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Period 1: Alemtuzumab/Tacrolimus | Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab. |
| FG001 | Period 1: Basiliximab/Tacrolimus |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: Alemtuzumab or Basiliximab |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan: Induction Therapy Data Analysis Plan | Feb 14, 2014 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Basiliximab | Drug | 20 mg intravenously, two doses 96 hours apart |
|
|
| Sirolimus | Drug | Sirolimus: target trough levels 6-12 ng/mL for first 6-months after maintenance therapy randomization, then 5-10 ng/mL |
|
|
| Tacrolimus | Drug | Tacrolimus: target trough levels 5-7 ng/mL after maintenance therapy randomization. |
|
|
Return to dialysis or re-transplantation by 18-months after randomization to maintenance therapy. |
| 2 years post-transplantation |
| Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy) | Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported within Period 1 (randomization to induction therapy of either Alemtuzumab (Campath-1H) and Tacrolimus, or Basiliximab and Tacrolimus). | 6-months post-transplantation |
| Number of Participants With Serious Infection (at 18-months After Randomization to Maintenance Therapy) | Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus). | 2 years post-transplantation |
| Number of Participants With Cancer (at 18-months After Randomization to Maintenance Therapy) | Occurrence of any cancer reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus). | 2 years post-transplantation |
| Number of Participants With Major Vascular Event (at 18-months After Randomization to Maintenance Therapy) | Composite of non-fatal myocardial infarction, non-fatal stroke, cardiovascular death or arterial revascularization | 2 years post-transplantation |
| Birmingham |
| United Kingdom |
| Addenbrooke's Hospital NHS Trust | Cambridge | United Kingdom |
| University Hospital of Wales | Cardiff | United Kingdom |
| University Hospitals Coventry & Warwickshire | Coventry | United Kingdom |
| Royal Infirmary | Edinburgh | United Kingdom |
| Western Infirmary | Glasgow | United Kingdom |
| Hull and East Yorkshire Hospitals NHS Trust | Hull | United Kingdom |
| Leeds Teaching Hospitals NHS Trust | Leeds | United Kingdom |
| Royal Liverpool and Broadgreen University Hospitals NHS Trust | Liverpool | United Kingdom |
| Bart's and the London NHS Trust | London | United Kingdom |
| Guy's and St Thomas's NHS Trust | London | United Kingdom |
| Kings College Hospital NHS Trust | London | United Kingdom |
| Royal Free Hampstead NHS Trust | London | United Kingdom |
| Central Manchester NHS Trust | Manchester | United Kingdom |
| Newcastle-upon-Tyne Hospitals NHS Trust | Newcastle | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | United Kingdom |
| Plymouth Teaching Hospitals NHS Trust | Plymouth | United Kingdom |
| Portsmouth Hospitals NHS Trust | Portsmouth | United Kingdom |
| Sheffield Teaching Hospitals NHS Trust | Sheffield | United Kingdom |
| 3C Study Collaborative Group. Campath, calcineurin inhibitor reduction, and chronic allograft nephropathy (the 3C Study) - results of a randomized controlled clinical trial. Am J Transplant. 2018 Jun;18(6):1424-1434. doi: 10.1111/ajt.14619. Epub 2018 Jan 9. |
| 23641902 | Derived | Haynes R, Baigent C, Harden P, Landray M, Akyol M, Asderakis A, Baxter A, Bhandari S, Chowdhury P, Clancy M, Emberson J, Gibbs P, Hammad A, Herrington W, Jayne K, Jones G, Krishnan N, Lay M, Lewis D, Macdougall I, Nathan C, Neuberger J, Newstead C, Pararajasingam R, Puliatti C, Rigg K, Rowe P, Sharif A, Sheerin N, Sinha S, Watson C, Friend P; 3C Study Collaborative Group. Campath, calcineurin inhibitor reduction and chronic allograft nephropathy (3C) study: background, rationale, and study protocol. Transplant Res. 2013 May 6;2(1):7. doi: 10.1186/2047-1440-2-7. |
Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab |
| FG002 | Period 2: Sirolimus | Sirolimus maintenance therapy: target trough level of 6-12 ng/mL for the first 6-months, then reducing to 5-10 ng/mL. |
| FG003 | Period 2: Tacrolimus | Tacrolimus maintenance therapy: target trough level of 5-7 ng/mL |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2: Tacrolimus or Sirolimus |
|
Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab).
Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Period 1: Alemtuzumab/Tacrolimus | Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart. Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab. |
| BG001 | Period 1: Basiliximab/Tacrolimus | Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart. Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab. |
| BG002 | Period 2: Sirolimus | Sirolimus maintenance therapy: target trough level of 6-12 ng/mL for the first 6-months, then reducing to 5-10 ng/mL. |
| BG003 | Period 2: Tacrolimus | Tacrolimus maintenance therapy: target trough level of 5-7 ng/mL. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Count of Participants | Participants |
| ||||||||||
| Age, Continuous | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Count of Participants | Participants |
| ||||||||||
| Race/Ethnicity, Customized | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | All 852 participants were recruited in the UK. | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Count of Participants | Participants |
| |||||||||
| Primary Renal Disease | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Count of Participants | Participants |
| ||||||||||
| Other Previous Disease | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Number | participants |
| ||||||||||
| Previous renal replacement | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Count of Participants | Participants |
| ||||||||||
| HLA mismatch level | HLA = human leucocyte antigen. Level 1: 0-0-0; Level 2: 0 HLA-DR and 0/1 HLA-B mismatches; Level 3: (0 HLA-DR and 2 HLA-B) or (1 HLA-DR and 0/1 HLA-B); Level 4: (1 HLA-DR and 2 HLA-B) or (2 HLA-DR). Level 1 being most favourable, Level 4 being least favourable. | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Count of Participants | Participants |
| |||||||||
| Previous transplant | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Count of Participants | Participants |
| ||||||||||
| Highly sensitised | Highly sensitised is defined as calculated reaction frequency >85% where the calculated reaction frequency is the proportion of the general UK population that the participant is predicted to be sensitised against. | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Count of Participants | Participants |
| |||||||||
| Virology serology | CMV=cytomegalovirus; EBV=Epstein-Barr virus. | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Number | Participants |
| |||||||||
| Type of donor | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Count of Participants | Participants |
| ||||||||||
| Donor sex | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Count of Participants | Participants |
| ||||||||||
| Cold ischaemia time (h) | For deceased donor transplants only. | Period 1: Baseline data (852 participants) at randomization to induction therapy (Alemtuzumab or Basiliximab). Period 2: 6-months post-transplantation, baseline data (394 of the original participants) at re-randomization to maintanence therapy (Sirolimus or Tacrolimus). | Mean | Standard Deviation | Hours |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Biopsy-proven Acute Rejection at 6-months After Randomization to Induction Therapy | Occurence of biopsy-proven acute rejection events at 6-months after transplantation during Period 1 (randomization to induction therapy (Campath-1H and Tacrolimus, or Basiliximab and Tacrolimus)) | Posted | Count of Participants | Participants | 6 months post-transplantation |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Graft Function (at 18-months After Randomization to Maintenance Therapy) | Estimated glomerular filtration rate (estimated using MDRD formula) at 18-months after maintenance therapy randomization to either Sirolimus or Tacrolimus. | Posted | Mean | Standard Error | mL/min/1.73m² | 2 years post-transplantation |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Graft Failure (at 6-months After Randomization to Induction Therapy) | Return to dialysis or re-transplantation by 6-months after randomization to induction therapy. | Posted | Count of Participants | Participants | 6 months post-transplantation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Graft Failure (at 18-Months After Randomization to Maintenance Therapy) | Return to dialysis or re-transplantation by 18-months after randomization to maintenance therapy. | Posted | Count of Participants | Participants | 2 years post-transplantation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Infection (at 6-months After Randomization to Induction Therapy) | Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported within Period 1 (randomization to induction therapy of either Alemtuzumab (Campath-1H) and Tacrolimus, or Basiliximab and Tacrolimus). | Posted | Count of Participants | Participants | 6-months post-transplantation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Infection (at 18-months After Randomization to Maintenance Therapy) | Occurrence of any serious infection (opportunistic or requiring admission to hospital) reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus). | Posted | Count of Participants | Participants | 2 years post-transplantation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cancer (at 18-months After Randomization to Maintenance Therapy) | Occurrence of any cancer reported during Period 2 (maintenance therapy randomization to either Sirolimus or Tacrolimus). | Posted | Count of Participants | Participants | 2 years post-transplantation |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Vascular Event (at 18-months After Randomization to Maintenance Therapy) | Composite of non-fatal myocardial infarction, non-fatal stroke, cardiovascular death or arterial revascularization | Posted | Count of Participants | Participants | 2 years post-transplantation |
|
|
Period 1: SAEs collected during the 6-months post-transplantation Period 2: SAEs collected between 6-months and 24-months post-transplantation
Information about the occurrence of serious adverse events was recorded at scheduled visits
Other (not including Serious) Adverse Events were not recorded or assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Period 1: Alemtuzumab/Tacrolimus | Induction therapy allocation: Alemtuzumab (Campath-1H) and Tacrolimus Alemtuzumab: Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart Tacrolimus: Target trough level 5-7 ng/mL for 6-months after alemtuzumab. | 11 | 426 | 341 | 426 | 0 | 0 |
| EG001 | Period 1: Basiliximab/Tacrolimus | Induction therapy allocation: Basiliximab and Tacrolimus Basiliximab: 20 mg intravenously, two doses 96 hours apart Tacrolimus: Target trough level 5-12 ng/mL for 6-months after basiliximab | 6 | 426 | 354 | 426 | 0 | 0 |
| EG002 | Period 2: Sirolimus | Maintenance therapy allocation: Sirolimus Target trough level of 6-12 ng/mL for the first 6-months then reducing to 5-10 ng/nL | 11 | 197 | 140 | 197 | 0 | 0 |
| EG003 | Period 2: Tacrolimus | Maintenancy therapy allocation: Tacrolimus Target trough level of 5-7 ng/mL | 9 | 197 | 134 | 197 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Ear and labyrinth disorders | Ear and labyrinth disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Endocrine disorders | Endocrine disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Eye disorders | Eye disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| General disorders and administration site conditions | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hepatobiliary disorders | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Immune system disorders | Immune system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Infections and infestations | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Investigations | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pregnancy, puerperium and perinatal conditions | Pregnancy, puerperium and perinatal conditions | MedDRA (14.0) | Systematic Assessment |
| |
| Psychiatric disorders | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Social circumstances | Social circumstances | MedDRA (14.0) | Systematic Assessment |
| |
| Surgical and medical procedures | Surgical and medical procedures | MedDRA (14.0) | Systematic Assessment |
| |
| Vascular disorders | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Peter Friend | University of Oxford | 01865223872 | ccc@ctsu.ox.ac.uk |
| Jan 16, 2019 |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 19, 2011 | Apr 23, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Maintenance Therapy Data Analysis Plan | Jul 20, 2016 | Aug 8, 2019 | SAP_002.pdf |
| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| D000077552 | Basiliximab |
| D020123 | Sirolimus |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
|
| Age, Period 2 |
|
|
|
| Age, Continuous, Period 2 |
|
|
|
| Sex, Period 2 |
|
|
|
| Ethnic origin, Period 2 |
|
|
|
|
| Primary renal disease, Period 2 |
|
|
|
| Vascular Disease |
|
|
| Cancer |
|
|
|
|
| HLA mismatch level, Period 2 |
|
|
|
| Previous transplant, Period 2 |
|
|
|
| Highly sensitized, Period 2 |
|
|
|
| EBV-positive donor to negative recipient |
|
|
|
| Type of donor, Period 2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
| Glomerulonephritis |
|
| Polycystic kidney disease |
|
| Chronic pyelonephritis |
|
| Hypertension |
|
| Renovascular disease |
|
| Other |
|
| Level 2 |
|
| Level 3 |
|
| Level 4 |
|
| ≥1 |
|
| No |
|
| Donation after circulatory death |
|
| Donation from living (related or unrelated) person |
|