Enhance Access to Kidney Transplantation and Living Kidney Donation (EnAKT LKD)

November 7, 2023 updated by: Lawson Health Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. 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.
  2. 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.
  3. 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.

  4. 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.

  5. 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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5W9
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

This is a pragmatic, two-arm, parallel-group, open-label, registry-based cluster randomized, superiority, clinical trial with eligibility criteria detailed below.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • None. Including all Ontario CKD programs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
CKD programs will continue to support access to kidney transplantation and living kidney donation as they usually do for CKD patients.
Experimental: Multicomponent intervention
A multicomponent intervention will be provided at chronic kidney disease (CKD) programs.
Other: Multicomponent intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4.17 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A patient receives a living donor kidney transplant
Time Frame: 4.17 years
Secondary outcome selected to understand living kidney donor transplant activity.
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
Secondary outcome selected to understand living kidney donor transplant activity.
4.17 years
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
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.
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
Secondary outcome selected to understand living kidney donor transplant activity.
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
Secondary outcome selected to understand living kidney donor transplant activity.
4.17 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of deceased donor kidney transplant
Time Frame: 4.17 years
Rate of deceased donor kidney transplant censoring at receipt of a living donor kidney transplant and at the censoring events included in the main trial analysis (i.e., emigration, trial end date [December 31, 2021], death, evidence of recovered kidney function, or on the date a recorded contraindication to transplant occurs [with the exception of age >75]).
4.17 years
Average number of months from the date of dialysis initiation (i.e. trial entry) to the date of referral
Time Frame: 4.17 years
This outcome is assessed in patients receiving maintenance dialysis who were referred to a transplant centre.
4.17 years
Rate of living kidney donor transplants
Time Frame: 4.17 years
This outcome is assessed in patients waitlisted for a deceased donor kidney transplant and censored at receipt of a deceased donor kidney transplant and at the censoring events included in the main trial analysis (i.e., emigration, trial end date [December 31, 2021], death, evidence of recovered kidney function, or on the date a recorded contraindication to transplant occurs [with the exception of age >75]).
4.17 years
Proportion of pre-emptive transplants
Time Frame: 4.17 years
This outcome is assessed in recipients of a living kidney donor transplant and restricted to patients who were not receiving dialysis when they entered the trial and not on dialysis at the time of transplant.
4.17 years
Average number of months from the date of referral to a transplant center to the date the first living donor candidate contacts the transplant centre for the intended recipient
Time Frame: 4.17 years
This outcome is assessed in recipients of a living kidney donor transplant.
4.17 years
Average number of months from the date of referral to a transplant center to date of the transplant surgery
Time Frame: 4.17 years
This outcome is assessed in recipients of a living or deceased donor kidney transplant.
4.17 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)
Institute for Clinical Evaluative Sciences (ICES)
Ontario Renal Network (part of Ontario Health)
Trillium Gift of Life Network (part of Ontario Health)

Investigators

  • Principal Investigator: Amit Garg, MD, PhD, London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

September 29, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-17-088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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