Enhance Access to Kidney Transplantation and Living Kidney Donation

NCT03329521 | Completed

• 1 other identifier: R-17-088
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Kidney Diseases; Kidney Failure; End Stage Renal Disease

Keywords

Cluster Randomized Controlled Trial; Kidney Transplant; Living Kidney Donation; Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  4.17 years

• A patient receives a living donor kidney transplant

  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).

  4.17 years

Other Outcomes (6)

• Rate of deceased donor kidney transplant

  4.17 years

• Average number of months from the date of dialysis initiation (i.e. trial entry) to the date of referral

  4.17 years

• Rate of living kidney donor transplants

  4.17 years

Study Arms (2)

Multicomponent intervention

EXPERIMENTAL

A multicomponent intervention will be provided at chronic kidney disease (CKD) programs.

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.

Interventions

Multicomponent intervention OTHER

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.

Multicomponent intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None. Including all Ontario CKD programs.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Institute for Clinical Evaluative Sciences (ICES): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Ontario Renal Network (part of Ontario Health): collaborator
• Trillium Gift of Life Network (part of Ontario Health): collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5W9, Canada

Location

Related Publications (7)

• 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 on behalf of the EnAKT LKD investigators. 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:doi:10.1177/2054358121997266.

  BACKGROUND

• Naylor 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.

  PMID: 35467514 BACKGROUND

• Dixon 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.

  PMID: 36438439 BACKGROUND

• Yohanna 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.

  PMID: 35340770 BACKGROUND

• Garg 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.

  PMID: 37922156 BACKGROUND

• Yohanna 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.

  PMID: 40104388 DERIVED

• 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.

  PMID: 33948191 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amit Garg, MD, PhD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: November 6, 2017
• Study Start: November 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)