Rejection; Transplant, KidneyPhase 3TACKLE-ITNCT06474273
A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients
A Phase 3 study testing Methylprednisolone and Prednisone in people with Rejection; Transplant, Kidney and Rejection; Transplant, Pancreas, run by University of Sydney at 30 sites in 3 countries.
Trial summary
After a kidney or a kidney-pancreas transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called rejection. One type of rejection is known as Acute T cell mediated rejection (TCMR). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Rejection; Transplant, Kidney, Rejection; Transplant, Pancreas
- What is being tested?
- Methylprednisolone and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 13 Mar 2026to Jun 2030
- Phase
- Phase 3
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants or their legal guardian must be able to understand and provide written informed consent;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- All ethnic and gender groups will have equal access to the study;
- All children (aged 2+ years) and adults who have received a kidney or SPK transplant with biopsy proven *acute TCMR (≥ Banff borderline (minimum i1 score) whether clinical or subclinical).
- Individuals with the following are eligible for inclusion:
- Concurrent acute TCMR and microvascular inflammation (MVI) defined as g+ptc, but without ABMR diagnosis.
- Concurrent acute TCMR and chronic active TCMR.
Who cannot join
- Individuals meeting any of the following criteria will be excluded from participation:
- Mixed rejection.
- Active or chronic active ABMR.
- Chronic active TCMR.
- Isolated v1 without inflammation.
- Concurrent renal disease, such as recurrent glomerulonephritis or polyomavirus nephropathy.
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- Active malignancies or active infection that preclude immunosuppression augmentation.
- Use of other immunomodulatory agents, including, but not limited to, Rituximab, Anti-TNF monoclonal antibody, Belatacept, Abatacept, Janus kinase inhibitors, Eculizumab, Pegcetacoplan.
- Enrolment in other interventional drug trials.
- Use of other investigational agents.
- Unable to adhere to the study protocol.
Trial locations and contacts
30 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
NHMRC Clinical Trials Centre THE UNIVERSITY OF SYDNEY contact
30 sites in 3 countries
Canada18 sites, 18 recruiting
- Not yet recruiting
Foothills Medical Centre
Calgary, Alberta, T2N 4Z6
Ngan Lam, MD, MSc
- Not yet recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Lorraine Hamiwka, MD
- Not yet recruiting
Stollery Children's Hospital
Edmonton, Alberta, T6G 1C9
Michelle Ruhl, MD, FRCPC
- Not yet recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Emily Christie, MD, FRCPC
- Not yet recruiting
QEII Health Sciences Centre, Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 1V8
Amanda Vinson, MD
- Not yet recruiting
London Health Science Centre
London, Ontario, N6A 5A5
Matthew Weir, MD, FRCPC
- Not yet recruiting
Centre Hospitalier de l'université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9
Daniel Fantus, MD, FRCPC
- Not yet recruiting
Glen Site
Montreal, Quebec, H3J 0A9
Shaifali Sandal, MD
- Not yet recruiting
CHU Ste-Justine
Montreal, Quebec, H3T 1C5
Véronique Phan, MD
- Not yet recruiting
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Beth Foster, MD, MSCE
- Not yet recruiting
CHU de Quebec
Québec, Quebec, G1R 2J6
Sacha De Serres, MD, FRCPC
- Not yet recruiting
St. Paul's Hospital
Saskatoon, Saskatchewan, S7M 0Z9
Rahul Manira, MD, FRCPC
- Not yet recruiting
St Mike's Hospital (Unity Health)
Toronto, Ontario, M5B 1W8
Darren Yuen, MD, PhD
- Not yet recruiting
University of Toronto - Hospital for Sick Kids
Toronto, Ontario, M5G 1E8
Chia Wei Teoh, MB B.Ch., BAO, LRCSI, MRCPI
- Not yet recruiting
Toronto General Hospital Research Institute (UHN)
Toronto, Ontario, M5G 2N2
Joseph Kim, MD, PhD
- Not yet recruiting
BC Children's Hospital
Vancouver, British Columbia, T6G 1C9
Tom Blydt-Hansen, MD
- Not yet recruiting
HSC Winnipeg Children's
Winnipeg, Manitoba, R3A 1R9
Aviva Goldberg, MD
- Not yet recruiting
Health Sciences Center, University of Manitoba
Winnipeg, Manitoba
Julie Ho, FRCPC
Australia11 sites, 11 recruiting
- Not yet recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Michael Collins, FRACP, PhD
- Not yet recruiting
Monash Medical Centre
Clayton, Victoria, 3168
William Mulley, FRACP, PhD
- Not yet recruiting
John Hunter Hospital
Lambton, New South Wales, 2305
Thida Myint, FRACP
- Not yet recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Suda Swaminathan, MBBS, FRACP, MCR
- Not yet recruiting
Royal Perth Children's hospital
Nedlands, Western Australia, 6009
Nick Larkins, FRACP, PhD
- Not yet recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Wai Lim, FRACP, PHD
- Not yet recruiting
Prince of Wales Hospital
Randwick, New South Wales, 2031
Kenneth Yong, FRACP, PhD
- Recruiting
Queensland Children's Hospital
South Brisbane, Queensland, 2014
Anna Francis, PhD, FRACP
- Not yet recruiting
The Sydney Children's Hospital Network
Westmead, New South Wales, 2145
Siah Kim, FRACP, PhD
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Germaine Wong, FRACP, Phd
- Not yet recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Ryan Gately, MBBS, Mbiostat, MClinEpi
New Zealand1 site, 1 recruiting
- Not yet recruiting
Auckland City Hospital
Grafton, Auckland, 1023
Helen Pilmore
About this study
Official title: A Multicenter Randomized Controlled Trial to Treat Acute t Cell Mediated Rejection in Kidney and Kidney-pancreas Transplant Recipients
After a kidney or a kidney-pancreas transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called rejection. One type of rejection is known as Acute T cell mediated rejection (TCMR). This can lead to many problems or even stop the transplant from working.
Doctors give strong steroids to treat this problem, but there are no rules for how much steroid to give. Too much steroids can cause problems like heart and bone problems, bad infections, and weight gain. That is why we need to find the right dose of steroids for each person to treat this.
TACKLE-IT is a study that will try to find the right steroid dose for treating rejection.
Read the detailed description
TACKLE-IT is an international, multi-centre, 2x2 factorial, PROBE-style, registry-embedded randomised controlled trial (RCT) that compares the effectiveness and safety of high vs low dose IV MP, and high vs low dose oral prednisone taper as the first-line therapy for acute TCMR in kidney and SPK transplant recipients. This RCT was conceived and developed through extensive consultation and collaboration with our key stakeholders, including transplant recipients with lived experience and the International TCMR Working Group with sponsorship by 4 international transplant societies (The Transplantation Society (TTS), American Society of Transplantation (AST), European Society of Transplantation (ESOT) and Transplant Society of Australia and New Zealand (TSANZ). TACKLE-IT is led by an international multi-disciplinary team of transplant health professionals, clinical trialists, biostatisticians, health economist, social scientist, consumers.
TACKLE-IT will address the critical unmet need and resolve a decades-long unanswered question, 'What is the minimally acceptable, safe and effective steroid dose for the treatment of acute TCMR in kidney and SPK transplant recipients?'
- Being tested
- Methylprednisolone, Prednisone
- Keywords
- Acute T cell mediated rejection
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called IV MP
IV Methylprednisolone
PrednisoneDrug
Oral prednisone augmentation
| Study group | Role | What they receive |
|---|---|---|
| Lower dose IV methylprednisolone x Lower dose oral prednisone | Experimental | Lower dose IV MP (250 mg daily x 3 days in adults or 150 mg/m² daily x 3, or to a max 250 mg/dose in children (<18 years), with lower dose (25mg daily x 7 days, or 15mg/m² x 7 days, or to a max 25mg/dose for those < 18 years ) oral prednisone augmentation then return to standard prednisone. Receives: Drug: Methylprednisolone; Drug: Prednisone |
| Lower dose IV methylprednisolone x Higher dose oral prednisone | Experimental | Lower dose IV MP (250 mg daily x 3 in adults or 150 mg/m² daily x 3, or to a max 250 mg/dose in children (<18 years), with higher dose (50mg daily x 7, or 30mg/m² daily x 7, or to a max 50mg/dose for those < 18 years) oral prednisone augmentation then return to standard prednisone. Receives: Drug: Methylprednisolone; Drug: Prednisone |
| Higher dose IV methylprednisolone x lower dose oral prednisone | Active comparator | Higher dose IV MP (500mg daily x 3 in adults or 300 mg/m² daily x 3 or to a max 500 mg/dose in children (<18 years), with lower dose (25mg daily x 7 days, or 15mg/m² daily x 7 days, or to a max 25mg/dose for those < 18 years) oral prednisone augmentation then return to standard prednisone. Receives: Drug: Methylprednisolone; Drug: Prednisone |
| Higher dose IV methylprednisolone x higher dose oral prednisone | Active comparator | Higher dose IV MP (500 mg daily x 3 in adults or 300 mg/m² daily x 3 or to a max 500 mg/dose in children (<18 years), with higher dose (50mg daily x 7 days, or 30mg/m² daily x 7 days, or to a max 50mg/dose for those < 18 years) oral prednisone augmentation, then return to standard prednisone. Receives: Drug: Methylprednisolone; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological resolution of biopsy-proven acute rejection
Histological resolution of biopsy-proven acute rejection is defined by the absence of any biopsy proven acute rejection (BPAR) on follow-up biopsy, including Banff Borderline (i1 t1), mixed rejection, ABMR and chronic active TCMR using Banff 2022 criteria.
Measured: 12 weeks post-randomization
Improvement in allograft function for clinical rejection; and defined by an average of at least 2 serum creatinine at baseline and at least 2 serum creatinine from 11-13 weeks
Reduction in serum creatinine ≥20% is defined as the relative reduction in serum creatinine from baseline and at 11-13 weeks after randomisation, in the absence of dialysis or achieving freedom from dialysis. Staff are required to record the serum creatinine at each visit; or dates and modality of dialysis initiation and / or discontinuation.
Measured: 11 to 13 weeks post-randomization
Avoidance of rescue therapies within 12 weeks post-randomization to achieve histological resolution and/or improvement in allograft function
Use of rescue therapy is defined as: the use of any adjunctive T and B cell depleting therapies such as intravenous thymoglobulin, alemtuzumab, bortezomib, or rituximab, or additional doses of IV MP within the first 12 weeks after randomisation.
Measured: 12 weeks post-randomization
Secondary outcomes (9)
All cause death and death-censored graft loss
All cause death and death-censored graft loss have been identified as the core outcomes for kidney transplant recipients. However, death and death-censored graft loss are anticipated to have a very low incidence at the 12 weeks post-randomization primary outcome ascertainment and were therefore not included in the primary composite outcome. They will be reported as principal secondary endpoints.
All-cause death also includes cause-specific death (infections, cancers, cardiovascular-related, and other causes of death) at 12 weeks after randomisation.
Measured: At 12 weeks post-randomization
Estimated glomerular filtration rate (eGFR)
- Absolute eGFR (2021 CKD-EPI eGFR without race modifier for adults, and the CKiD U25 equation to estimate GFR in children <18 years) 12, 24 and 48 weeks.
- Decline in eGFR (slope) from randomization to 48 weeks.
Measured: At 12, 24 and 48 weeks post-randomization
Urine albumin: creatinine ratios
Urine ACR is measured as standard of care. Rationale: ACR screens for graft dysfunction and is a marker for graft outcomes
Measured: At 12, 24 and 48 weeks post-randomization
Trajectories of serum creatinine changes
Measured: From randomization to 48 weeks post-randomization
Development of acute antibody mediated rejection (ABMR) and mixed rejection (concomitant ABMR + TCMR)
Development of acute antibody mediated rejection (ABMR) and mixed rejection (concomitant ABMR + TCMR) within 48 weeks after randomisation. ABMR and mixed rejection are defined according to the Banff 2022 criteria
Measured: 48 weeks post-randomization
Development of chronic fibrosis in the allograft
Development of chronic fibrosis in the allograft. This is defined as the absolute (Banff ci+ctscores) at 12 weeks
Measured: Baseline to 12 weeks post-randomization
Infections (all types and sites)
All types and number of events related to infections that required antimicrobials and hospitalisation for infections will be recorded.
Measured: Anytime from randomization to 48 weeks post-randomization
Quality of life (QoL)
QoL will be assessed using the EuroQol-5 Dimension-5 Level (EQ-5D-5L) for adult participants (aged ≥18 years). For paediatric participants (aged 2-17 years), age-appropriate versions of the EuroQol Youth version (EQ-5D-Y) will be used as follows:
- Ages 2-7: EQ-5D-Y proxy version
- Ages 8-17: EQ-5D-Y self-report version
Both the EQ-5D-5L and EQ-5D-Y report utility scores ranging from -0.281 to 1 (EQ-5D-5L UK value set) and -0.109 to 1 (EQ-5D-Y, proxy or self-report), where 1 represents perfect health, 0 represents a health state equivalent to death, and negative scores represent health states worse than death. Higher scores indicate better health-related quality of life.
Measured: Baseline (at randomization), 12 weeks , 24 weeks , and 48 weeks post-randomization
Cancer
All types and sites
Measured: Anytime from randomization to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start13 Mar 2026
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Rejection; Transplant, KidneyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- International, multicentre, 2x2 factorial, PROBE-style, non-inferiority, registry-embedded RCT of lower vs higher dose IV MP (methylprednisolone), and lower vs higher oral prednisone dose augmentation. The IV methylprednisolone component is open-label. The oral prednisone component remains triple-blinded, and all primary and key secondary endpoints will be assessed using blinded central adjudication.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Sponsor
- Investigators
- Germaine Wong, PhD, FRACP, Principal investigator, University of SydneyJulie Ho, FRCPC, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474273
- Sponsor's protocol ID
- GWCT051274
- Acronym
- TACKLE-IT
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data collected for the study, including individual patient data and a data dictionary that defines each field in the data set, will be made available as deidentified participant data to researchers who propose to use the data for individual patient data meta-analysis. Data will be shared following approval of the proposal by the corresponding author and a signed data access agreement, beginning 2 years following main publication.
Publications
Wiebe C, Gibson IW, Blydt-Hansen TD, Karpinski M, Ho J, Storsley LJ, Goldberg A, Birk PE, Rush DN, Nickerson PW. Evolution and clinical pathologic correlations of de novo donor-specific HLA antibody post kidney transplant. Am J Transplant. 2012 May;12(5):1157-67. doi: 10.1111/j.1600-6143.2012.04013.x. Epub 2012 Mar 19.
PubMed 22429309Wiebe C, Kosmoliaptsis V, Pochinco D, Gibson IW, Ho J, Birk PE, Goldberg A, Karpinski M, Shaw J, Rush DN, Nickerson PW. HLA-DR/DQ molecular mismatch: A prognostic biomarker for primary alloimmunity. Am J Transplant. 2019 Jun;19(6):1708-1719. doi: 10.1111/ajt.15177. Epub 2018 Dec 15.
PubMed 30414349Wiebe C, Rush DN, Gibson IW, Pochinco D, Birk PE, Goldberg A, Blydt-Hansen T, Karpinski M, Shaw J, Ho J, Nickerson PW. Evidence for the alloimmune basis and prognostic significance of Borderline T cell-mediated rejection. Am J Transplant. 2020 Sep;20(9):2499-2508. doi: 10.1111/ajt.15860. Epub 2020 Apr 9.
PubMed 32185878Nickerson PW, Balshaw R, Wiebe C, Ho J, Gibson IW, Bridges ND, Rush DN, Heeger PS. A noninferiority design for a delayed calcineurin inhibitor substitution trial in kidney transplantation. Am J Transplant. 2021 Apr;21(4):1503-1512. doi: 10.1111/ajt.16311. Epub 2020 Oct 6.
PubMed 32956576Rampersad C, Balshaw R, Gibson IW, Ho J, Shaw J, Karpinski M, Goldberg A, Birk P, Rush DN, Nickerson PW, Wiebe C. The negative impact of T cell-mediated rejection on renal allograft survival in the modern era. Am J Transplant. 2022 Mar;22(3):761-771. doi: 10.1111/ajt.16883. Epub 2021 Nov 24.
PubMed 34717048Ho J, Okoli GN, Rabbani R, Lam OLT, Reddy VK, Askin N, Rampersad C, Trachtenberg A, Wiebe C, Nickerson P, Abou-Setta AM. Effectiveness of T cell-mediated rejection therapy: A systematic review and meta-analysis. Am J Transplant. 2022 Mar;22(3):772-785. doi: 10.1111/ajt.16907. Epub 2021 Dec 10.
PubMed 34860468Nankivell BJ, Shingde M, Keung KL, Fung CL, Borrows RJ, O'Connell PJ, Chapman JR. The causes, significance and consequences of inflammatory fibrosis in kidney transplantation: The Banff i-IFTA lesion. Am J Transplant. 2018 Feb;18(2):364-376. doi: 10.1111/ajt.14609. Epub 2018 Jan 3.
PubMed 29194971Tong A, Budde K, Gill J, Josephson MA, Marson L, Pruett TL, Reese PP, Rosenbloom D, Rostaing L, Warrens AN, Wong G, Craig JC, Crowe S, Harris T, Hemmelgarn B, Manns B, Tugwell P, Van Biesen W, Wheeler DC, Winkelmayer WC, Evangelidis N, Sautenet B, Howell M, Chapman JR. Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation. Transplant Direct. 2016 May 19;2(6):e79. doi: 10.1097/TXD.0000000000000593. eCollection 2016 Jun.
PubMed 27500269Sautenet B, Tong A, Chapman JR, Warrens AN, Rosenbloom D, Wong G, Gill J, Budde K, Rostaing L, Marson L, Josephson MA, Reese PP, Pruett TL, Evangelidis N, Craig JC. Range and Consistency of Outcomes Reported in Randomized Trials Conducted in Kidney Transplant Recipients: A Systematic Review. Transplantation. 2018 Dec;102(12):2065-2071. doi: 10.1097/TP.0000000000002278.
PubMed 29781954Sautenet B, Tong A, Manera KE, Chapman JR, Warrens AN, Rosenbloom D, Wong G, Gill J, Budde K, Rostaing L, Marson L, Josephson MA, Reese PP, Pruett TL, Hanson CS, O'Donoghue D, Tam-Tham H, Halimi JM, Shen JI, Kanellis J, Scandling JD, Howard K, Howell M, Cross N, Evangelidis N, Masson P, Oberbauer R, Fung S, Jesudason S, Knight S, Mandayam S, McDonald SP, Chadban S, Rajan T, Craig JC. Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation: A Multinational Delphi Survey With Patients, Caregivers, and Health Professionals. Transplantation. 2017 Aug;101(8):1875-1886. doi: 10.1097/TP.0000000000001776.
PubMed 28738403Tong A, Gill J, Budde K, Marson L, Reese PP, Rosenbloom D, Rostaing L, Wong G, Josephson MA, Pruett TL, Warrens AN, Craig JC, Sautenet B, Evangelidis N, Ralph AF, Hanson CS, Shen JI, Howard K, Meyer K, Perrone RD, Weiner DE, Fung S, Ma MKM, Rose C, Ryan J, Chen LX, Howell M, Larkins N, Kim S, Thangaraju S, Ju A, Chapman JR; SONG-Tx Investigators. Toward Establishing Core Outcome Domains For Trials in Kidney Transplantation: Report of the Standardized Outcomes in Nephrology-Kidney Transplantation Consensus Workshops. Transplantation. 2017 Aug;101(8):1887-1896. doi: 10.1097/TP.0000000000001774.
PubMed 28737661Tong A, Sautenet B, Poggio ED, Lentine KL, Oberbauer R, Mannon R, Murphy B, Padilla B, Chow KM, Marson L, Chadban S, Craig JC, Ju A, Manera KE, Hanson CS, Josephson MA, Knoll G; SONG-Tx Graft Health Workshop Investigators. Establishing a Core Outcome Measure for Graft Health: A Standardized Outcomes in Nephrology-Kidney Transplantation (SONG-Tx) Consensus Workshop Report. Transplantation. 2018 Aug;102(8):1358-1366. doi: 10.1097/TP.0000000000002125.
PubMed 29470347Ju A, Josephson MA, Butt Z, Jowsey-Gregoire S, Tan J, Taylor Q, Fowler K, Dobbels F, Caskey F, Jha V, Locke J, Knoll G, Ahn C, Hanson CS, Sautenet B, Manera K, Craig JC, Howell M, Rutherford C, Tong A, Harden P, Hawley C, Holdaas H, Israni A, Jesse M, Kane B, Kanellis J, Kiberd B, Kim J, Larsen C, Leichtman A, Lentine K, Malone A, Mannon R, Oberbauer R, Patzer R, Peipert JD, Phan HA, Poggio E, Reed R, Scandling J, Tang I, Watson C, Contrares D, Contreras P, Cross D, Juodvalkis E, Koide D, Koide J, Kozarewicz A, Kozarewicz L, Kozarewicz R, Koritala A, Lisiecki E, Lipuma C, Lyman M, Mueller R, Mueller G, Noble L, Nolan N, Nolan S, Thomas J, Urbancyzk L, Zerante J, Zerante S; SONG-Tx Life Participation Workshop Investigators; Health professionals (*includes 2 patients from the SONG-Tx Graft Health Expert Working Group); Patients and family members. Establishing a Core Outcome Measure for Life Participation: A Standardized Outcomes in Nephrology-kidney Transplantation Consensus Workshop Report. Transplantation. 2019 Jun;103(6):1199-1205. doi: 10.1097/TP.0000000000002476.
PubMed 30300284Ju A, Chow BY, Ralph AF, Howell M, Josephson MA, Ahn C, Butt Z, Dobbels F, Fowler K, Jowsey-Gregoire S, Jha V, Locke JE, Tan JC, Taylor Q, Rutherford C, Craig JC, Tong A. Patient-reported outcome measures for life participation in kidney transplantation: A systematic review. Am J Transplant. 2019 Aug;19(8):2306-2317. doi: 10.1111/ajt.15267. Epub 2019 Feb 28.
PubMed 30664327