Kidney DiseasesEnAKT LKDNCT03329521
Enhance Access to Kidney Transplantation and Living Kidney Donation
A study testing Multicomponent intervention in people with Kidney Diseases and Kidney Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Compared to dialysis, kidney transplantation is associated with improved survival, better quality of life and substantial cost savings to healthcare systems. Despite these advantages, many individuals with kidney failure will never receive a kidney transplant. A multicomponent intervention (vs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Diseases, Kidney Failure, End Stage Renal Disease
- What is being tested?
- Multicomponent intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All 26 chronic kidney disease (CKD) programs in Ontario. These programs provide care for all chronic dialysis patients in the province. Each CKD program also provides a multi-care kidney clinic for patients with advanced CKD who are approaching the need for dialysis.
Who cannot join
- None. Including all Ontario CKD programs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicomponent Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) in Patients With Chronic Kidney Disease: A Pragmatic, Registry-based, Cluster-Randomized Clinical Trial
Compared to dialysis, kidney transplantation is associated with improved survival, better quality of life and substantial cost savings to healthcare systems. Despite these advantages, many individuals with kidney failure will never receive a kidney transplant. A multicomponent intervention (vs. usual care) provided in chronic kidney disease (CKD) programs located in Ontario, Canada was developed to determine if it can enable more patients with no recorded contraindications to kidney transplant to complete more steps towards receiving a kidney transplant. These CKD programs provide care to individuals with CKD (including patients approaching the need for dialysis and patients receiving dialysis). The intervention has four main components: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors (i.e. Transplant Ambassador Program); and (4) program-level performance reports and oversight by program leaders. The Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial will provide high-quality evidence on whether a multicomponent intervention helps patients complete more steps towards receiving a kidney transplant.
Read the detailed description
- Statement of the health problem or issue: Compared with dialysis, a kidney transplant offers patients a better quality of life and many gain 10 or more years of life expectancy. A transplant also costs the healthcare system less-over a five-year period. Living donor transplants offer further advantages, including superior graft and patient survival compared with deceased donor transplants. Unfortunately, many patients with kidney failure who would benefit from a transplant will never receive one. There is a chronic shortage of organs from deceased donors, and in Canada, the rate of living donor kidney transplantation has stagnated. In addition to the shortage of transplantable kidneys, several other barriers impede patient access to transplantation.
- Objective of your project: To determine if a multicomponent intervention provided in chronic kidney disease (CKD) programs (vs. usual care) enables more patients with no recorded contraindications to kidney transplant to complete more steps towards receiving a kidney transplant.
- How will you undertake your work? We will conduct a pragmatic two-arm, parallel-group, open-label, registry-based, cluster-randomized, superiority, clinical trial-the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial. Our study will include the 26 chronic kidney disease (CKD) programs in Ontario, Canada which are expected to care for over 10,000 adult patients with CKD (including patients approaching the need for dialysis and patients receiving dialysis) with no recorded contraindications to a kidney transplant during the trial. Patients in 13 of the 26 CKD programs will receive a multicomponent intervention or usual care. The intervention has four main components: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Patients in the other 13 programs will receive usual care and will continue to receive support in accessing kidney transplantation and living kidney donation as usual.
- What is unique/innovative about your project? An investigator usually needs to study a large number of patients in a clinical trial to reliably understand the effects of an intervention. Normally, a study with 10,000 patients would cost more than $10 million dollars to conduct; however, this study will provide a reliable answer to the question being asked and can be done at a fraction of the cost. This is because we will use data routinely collected by the healthcare system. The investigator will be able to analyze these healthcare data at the end of the study. This means that the study will cost less than a traditional clinical trial. Also unique to this trial, is that that the intervention was embedded and delivered in routine care. This pragmatic trial includes all CKD programs in the province of Ontario. By including patients from a variety of backgrounds, the results of the trial should be broadly generalizable.
- What is the impact of the proposed research? The EnAKT LKD trial will provide high-quality evidence on whether a multicomponent intervention helps patients complete more steps towards receiving a kidney transplant. This is important as compared to dialysis, kidney transplant offers patients a better quality of life and many gain 10 or more years of life expectancy. A transplant also costs the healthcare system less. If our intervention is successful, more transplants may ultimately be performed and result in improved survival and a better quality of life for patients with CKD. Kidney transplantation achieves the triple aim in healthcare: better outcomes, better experience of care, and lower costs.
- Conditions
- Kidney Diseases, Kidney Failure, End Stage Renal Disease
- Being tested
- Multicomponent intervention
- Keywords
- Cluster Randomized Controlled Trial, Kidney Transplant, Living Kidney Donation, Kidney Disease
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent interventionOther
Patients in 13 of the 26 CKD programs will receive a multicomponent intervention or usual care. The intervention has four main components: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent intervention | Experimental | A multicomponent intervention will be provided at chronic kidney disease (CKD) programs. Receives: Other: Multicomponent intervention |
| Usual Care | No intervention | CKD programs will continue to support access to kidney transplantation and living kidney donation as they usually do for CKD patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completing key steps toward receiving a kidney transplant
The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant wait list, and (4) patient receives a kidney transplant from a living or deceased donor.
Measured: 4.17 years
Secondary outcomes (5)
A potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient and/or a patient receives a living donor transplant.
Given that the average wait time for a deceased donor kidney transplant is five years on average in Ontario, our intervention is likely to have only a small impact on the rate of deceased donor kidney transplants. For this reason, we have pre-specified five secondary outcomes to examine the impact of our intervention on living kidney donor transplant activity.
Measured: 4.17 years
Time to first occurrence of a potential living kidney donor beginning their evaluation at a transplant center to donate a kidney to the patient.
Secondary outcome selected to understand living kidney donor transplant activity.
Measured: 4.17 years
A transplant center receives a patient's complete referral package from a chronic kidney disease program and at least one potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient.
Secondary outcome selected to understand living kidney donor transplant activity.
Measured: 4.17 years
A patient receives a living donor kidney transplant
Secondary outcome selected to understand living kidney donor transplant activity.
Measured: 4.17 years
A patient receives a pre-emptive living donor kidney transplant (restricted to patients who were not receiving dialysis when they entered the trial and not on dialysis at the time of transplant).
Secondary outcome selected to understand living kidney donor transplant activity.
Measured: 4.17 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences, Canadian Institutes of Health Research (CIHR), Ontario Renal Network (part of Ontario Health), Trillium Gift of Life Network (part of Ontario Health)
- Responsible party
- Sponsor
- Investigators
- Amit Garg, MD, PhD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329521
- Sponsor's protocol ID
- R-17-088
- Acronym
- EnAKT LKD
- Status last verified
- Nov 2023
- First submitted
- 29 Sep 2017
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: While data sharing agreements prohibit ICES from making the data publicly available, access may be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS. The full dataset creation plan and underlying analytic code are available from the authors upon request, understanding that the programs may rely upon coding templates or macros that are unique to ICES.
Publications
Yohanna S, Naylor KL, Mucsi I, McKenzie S, Belenko D, Blake PG, Coghlan C, Dixon SN, Elliott L, Getchell L, Ki V, Nesrallah G, Patzer RE, Presseau J, Reich M, Sontrop JM, Treleaven D, Waterman AD, Zaltzman J, Garg AX. A Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) in Patients With Chronic Kidney Disease: Clinical Research Protocol of a Cluster-Randomized Clinical Trial. Can J Kidney Health Dis. 2021 Apr 15;8:2054358121997266. doi: 10.1177/2054358121997266. eCollection 2021.
PubMed 33948191Naylor KL, McKenzie SQ, Garg AX, Yohanna S, Sontrop JM. Partnering with Patients to Enhance Access to Kidney Transplantation and Living Kidney Donation. Healthc Q. 2022 Apr;24(SP):69-73. doi: 10.12927/hcq.2022.26771.
PubMed 35467514Dixon SN, Naylor KL, Yohanna S, McKenzie S, Belenko D, Blake PG, Coghlan C, Cooper R, Elliott L, Getchell L, Ki V, Mucsi I, Nesrallah G, Patzer RE, Presseau J, Reich M, Sontrop JM, Treleaven D, Waterman AD, Zaltzman J, Garg AX. Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD): Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial. Can J Kidney Health Dis. 2022 Nov 22;9:20543581221131201. doi: 10.1177/20543581221131201. eCollection 2022.
PubMed 36438439Yohanna S, Wilson M, Naylor KL, Garg AX, Sontrop JM, Belenko D, Elliott L, McKenzie S, Macanovic S, Mucsi I, Patzer R, Voronin I, Lui I, Blake PG, Waterman AD, Treleaven D, Presseau J. Protocol for a Process Evaluation of the Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) Cluster-Randomized Clinical Trial. Can J Kidney Health Dis. 2022 Mar 19;9:20543581221084502. doi: 10.1177/20543581221084502. eCollection 2022.
PubMed 35340770Garg AX, Yohanna S, Naylor KL, McKenzie SQ, Mucsi I, Dixon SN, Luo B, Sontrop JM, Beaucage M, Belenko D, Coghlan C, Cooper R, Elliott L, Getchell L, Heale E, Ki V, Nesrallah G, Patzer RE, Presseau J, Reich M, Treleaven D, Wang C, Waterman AD, Zaltzman J, Blake PG. Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: The EnAKT LKD Cluster Randomized Clinical Trial. JAMA Intern Med. 2023 Dec 1;183(12):1366-1375. doi: 10.1001/jamainternmed.2023.5802.
PubMed 37922156Yohanna S, Wilson M, Naylor KL, Garg AX, Sontrop JM, Mucsi I, Belenko D, Dixon SN, Blake PG, Cooper R, Elliott L, Heale E, Macanovic S, Patzer R, Waterman AD, Treleaven D, Coghlan C, Reich M, McKenzie S, Presseau J. Process Evaluation Alongside a Cluster-Randomized Trial of a Multicomponent Intervention Designed to Improve Patient Access to Kidney Transplantation. Can J Kidney Health Dis. 2025 Mar 17;12:20543581251323959. doi: 10.1177/20543581251323959. eCollection 2025.
PubMed 40104388
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) in Patients With Chronic Kidney Disease: A Pragmatic, Registry-based, Cluster-Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03329521
- Acronym / sponsor ID
- EnAKT LKD / R-17-088
- Conditions
- Kidney Diseases, Kidney Failure, End Stage Renal Disease
- Keywords
- Cluster Randomized Controlled Trial, Kidney Transplant, Living Kidney Donation, Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Institute for Clinical Evaluative Sciences, Canadian Institutes of Health Research (CIHR), Ontario Renal Network (part of Ontario Health), Trillium Gift of Life Network (part of Ontario Health)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compared to dialysis, kidney transplantation is associated with improved survival, better quality of life and substantial cost savings to healthcare systems. Despite these advantages, many individuals with kidney failure will never receive a kidney transplant. A multicomponent intervention (vs. usual care) provided in chronic kidney disease (CKD) programs located in Ontario, Canada was developed to determine if it can enable more patients with no recorded contraindications to kidney transplant to complete more steps towards receiving a kidney transplant. These CKD programs provide care to individuals with CKD (including patients approaching the need for dialysis and patients receiving dialysis). The intervention has four main components: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors (i.e. Transplant Ambassador Program); and (4) program-level performance reports and oversight by program leaders. The Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial will provide high-quality evidence on whether a multicomponent intervention helps patients complete more steps towards receiving a kidney transplant.
Detailed description
- Statement of the health problem or issue: Compared with dialysis, a kidney transplant offers patients a better quality of life and many gain 10 or more years of life expectancy. A transplant also costs the healthcare system less-over a five-year period. Living donor transplants offer further advantages, including superior graft and patient survival compared with deceased donor transplants. Unfortunately, many patients with kidney failure who would benefit from a transplant will never receive one. There is a chronic shortage of organs from deceased donors, and in Canada, the rate of living donor kidney transplantation has stagnated. In addition to the shortage of transplantable kidneys, several other barriers impede patient access to transplantation.
- Objective of your project: To determine if a multicomponent intervention provided in chronic kidney disease (CKD) programs (vs. usual care) enables more patients with no recorded contraindications to kidney transplant to complete more steps towards receiving a kidney transplant.
- How will you undertake your work? We will conduct a pragmatic two-arm, parallel-group, open-label, registry-based, cluster-randomized, superiority, clinical trial-the Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) trial. Our study will include the 26 chronic kidney disease (CKD) programs in Ontario, Canada which are expected to care for over 10,000 adult patients with CKD (including patients approaching the need for dialysis and patients receiving dialysis) with no recorded contraindications to a kidney transplant during the trial. Patients in 13 of the 26 CKD programs will receive a multicomponent intervention or usual care. The intervention has four main components: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. Patients in the other 13 programs will receive usual care and will continue to receive support in accessing kidney transplantation and living kidney donation as usual.
- What is unique/innovative about your project? An investigator usually needs to study a large number of patients in a clinical trial to reliably understand the effects of an intervention. Normally, a study with 10,000 patients would cost more than $10 million dollars to conduct; however, this study will provide a reliable answer to the question being asked and can be done at a fraction of the cost. This is because we will use data routinely collected by the healthcare system. The investigator will be able to analyze these healthcare data at the end of the study. This means that the study will cost less than a traditional clinical trial. Also unique to this trial, is that that the intervention was embedded and delivered in routine care. This pragmatic trial includes all CKD programs in the province of Ontario. By including patients from a variety of backgrounds, the results of the trial should be broadly generalizable.
- What is the impact of the proposed research? The EnAKT LKD trial will provide high-quality evidence on whether a multicomponent intervention helps patients complete more steps towards receiving a kidney transplant. This is important as compared to dialysis, kidney transplant offers patients a better quality of life and many gain 10 or more years of life expectancy. A transplant also costs the healthcare system less. If our intervention is successful, more transplants may ultimately be performed and result in improved survival and a better quality of life for patients with CKD. Kidney transplantation achieves the triple aim in healthcare: better outcomes, better experience of care, and lower costs.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multicomponent intervention | Experimental | Other: Multicomponent interventionA multicomponent intervention will be provided at chronic kidney disease (CKD) programs. |
| Usual Care | No intervention | –CKD programs will continue to support access to kidney transplantation and living kidney donation as they usually do for CKD patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All 26 chronic kidney disease (CKD) programs in Ontario. These programs provide care for all chronic dialysis patients in the province. Each CKD program also provides a multi-care kidney clinic for patients with advanced CKD who are approaching the need for dialysis.
Key exclusion criteria (1 listed)
- None. Including all Ontario CKD programs.
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 |
|---|---|---|
| Multicomponent interventionPatients in 13 of the 26 CKD programs will receive a multicomponent intervention or usual care. The intervention has four main components: (1) support for local quality improvement teams and administrative needs; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders. | Other | Multicomponent intervention |
Primary outcome
Completing key steps toward receiving a kidney transplant
Time frame: 4.17 years
The primary outcome is completing key steps toward receiving a kidney transplant, where up to 4 unique steps per patient will be considered: (1) patient referred to a transplant center for evaluation, (2) a potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient, (3) patient added to the deceased donor transplant wait list, and (4) patient receives a kidney transplant from a living or deceased donor.
5 secondary outcomes
A potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient and/or a patient receives a living donor transplant.
Time frame: 4.17 years
Time to first occurrence of a potential living kidney donor beginning their evaluation at a transplant center to donate a kidney to the patient.
Time frame: 4.17 years
A transplant center receives a patient's complete referral package from a chronic kidney disease program and at least one potential living kidney donor begins their evaluation at a transplant center to donate a kidney to the patient.
Time frame: 4.17 years
A patient receives a living donor kidney transplant
Time frame: 4.17 years
A patient receives a pre-emptive living donor kidney transplant (restricted to patients who were not receiving dialysis when they entered the trial and not on dialysis at the time of transplant).
Time frame: 4.17 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 33948191Yohanna S, Naylor KL, Mucsi I, McKenzie S, Belenko D, Blake PG, Coghlan C, Dixon SN, Elliott L, Getchell L, Ki V, Nesrallah G, Patzer RE, Presseau J, Reich M, Sontrop JM, Treleaven D, Waterman AD, Zaltzman J, Garg AX. A Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) in Patients With Chronic Kidney Disease: Clinical Research Protocol of a Cluster-Randomized Clinical Trial. Can J Kidney Health Dis. 2021 Apr 15;8:2054358121997266. doi: 10.1177/2054358121997266. eCollection 2021.
- Background: PubMed 35467514Naylor KL, McKenzie SQ, Garg AX, Yohanna S, Sontrop JM. Partnering with Patients to Enhance Access to Kidney Transplantation and Living Kidney Donation. Healthc Q. 2022 Apr;24(SP):69-73. doi: 10.12927/hcq.2022.26771.
- Background: PubMed 36438439Dixon SN, Naylor KL, Yohanna S, McKenzie S, Belenko D, Blake PG, Coghlan C, Cooper R, Elliott L, Getchell L, Ki V, Mucsi I, Nesrallah G, Patzer RE, Presseau J, Reich M, Sontrop JM, Treleaven D, Waterman AD, Zaltzman J, Garg AX. Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD): Statistical Analysis Plan of a Registry-Based, Cluster-Randomized Clinical Trial. Can J Kidney Health Dis. 2022 Nov 22;9:20543581221131201. doi: 10.1177/20543581221131201. eCollection 2022.
- Background: PubMed 35340770Yohanna S, Wilson M, Naylor KL, Garg AX, Sontrop JM, Belenko D, Elliott L, McKenzie S, Macanovic S, Mucsi I, Patzer R, Voronin I, Lui I, Blake PG, Waterman AD, Treleaven D, Presseau J. Protocol for a Process Evaluation of the Quality Improvement Intervention to Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD) Cluster-Randomized Clinical Trial. Can J Kidney Health Dis. 2022 Mar 19;9:20543581221084502. doi: 10.1177/20543581221084502. eCollection 2022.
- Background: PubMed 37922156Garg AX, Yohanna S, Naylor KL, McKenzie SQ, Mucsi I, Dixon SN, Luo B, Sontrop JM, Beaucage M, Belenko D, Coghlan C, Cooper R, Elliott L, Getchell L, Heale E, Ki V, Nesrallah G, Patzer RE, Presseau J, Reich M, Treleaven D, Wang C, Waterman AD, Zaltzman J, Blake PG. Effect of a Novel Multicomponent Intervention to Improve Patient Access to Kidney Transplant and Living Kidney Donation: The EnAKT LKD Cluster Randomized Clinical Trial. JAMA Intern Med. 2023 Dec 1;183(12):1366-1375. doi: 10.1001/jamainternmed.2023.5802.
- Derived from this study: PubMed 40104388Yohanna S, Wilson M, Naylor KL, Garg AX, Sontrop JM, Mucsi I, Belenko D, Dixon SN, Blake PG, Cooper R, Elliott L, Heale E, Macanovic S, Patzer R, Waterman AD, Treleaven D, Coghlan C, Reich M, McKenzie S, Presseau J. Process Evaluation Alongside a Cluster-Randomized Trial of a Multicomponent Intervention Designed to Improve Patient Access to Kidney Transplantation. Can J Kidney Health Dis. 2025 Mar 17;12:20543581251323959. doi: 10.1177/20543581251323959. eCollection 2025.
- Individual participant dataSharing planned: No. While data sharing agreements prohibit ICES from making the data publicly available, access may be granted to those who meet prespecified criteria for confidential access, available at www.ices.on.ca/DAS. The full dataset creation plan and underlying analytic code are available from the authors upon request, understanding that the programs may rely upon coding templates or macros that are unique to ICES.
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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.
Amit Garg, MD, PhD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent intervention in people with Kidney Diseases and Kidney Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 1 inclusion and 1 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 9 Nov 2023. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Completing key steps toward receiving a kidney transplant (time frame: 4.17 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03329521, which also lists 6 linked publications.
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 9 Nov 2023.