NCT05154773: KidneyTIME

Increasing Live Donor Kidney Transplantation Through Video-based Education and Mobile Communication

Active, enrolled NA Results posted Last updated 3 April 2026

What this trial tests

NA trial testing Kidney donation and transplant information made easy in End-stage Renal Disease in 422 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 April 2022

Primary endpoint
30 September 2024

30 March 2026

Quick facts

Lead sponsor	State University of New York at Buffalo
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	422
Start date	1 April 2022
Primary completion	30 September 2024
Estimated completion	30 March 2026
Sites	1 location across United States

Drugs / interventions tested

• Kidney donation and transplant information made easy

Conditions studied

• End-stage Renal Disease — all drugs for End-stage Renal Disease →
• Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →

Sponsor

State University of New York at Buffalo

Who can join

Eligibility, any sex, with End-stage Renal Disease or Chronic Kidney Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Living Donor Inquiry Primary · 12 months

Living donor inquiry to the transplant center on behalf of the participant by telephone, email, or mail within 12 months from enrollment. Each inquiry is captured for all patients as a discrete field in the electronic medical record within 12 months from enrollment. An inquiry includes any request for information or evaluation to be a living kidney donor in which the recipients' name is specified.

Group	Value	95% CI
KidneyTIME	16.0
Usual Care	18.6

Living Donor Kidney Transplant Knowledge Secondary · Immediately post baseline, 1 month, 6 month, and 12 months

Developed specifically for this study as a measure of patients' knowledge about LDKT as delivered in the intervention condition. In this 12-item true-false questionnaire, total scores range from 0-12 with higher scores indicating greater LDKT-related knowledge. The scale captured different dimensions of knowledge including donor eligibility criteria, clinical outcomes, costs of the donation procedure, donor diet and medications, donor priority for transplant, and kidney paired donation.

Immediate

Group	Value	95% CI
KidneyTIME	11.1	± 1.2
Usual Care	10.4	± 1.4

1 Month

Group	Value	95% CI
KidneyTIME	11.1	± 1.3
Usual Care	10.4	± 1.8

6 Months

Group	Value	95% CI
KidneyTIME	11.0	± 1.3
Usual Care	10.6	± 1.4

12 Months

Group	Value	95% CI
KidneyTIME	11.1	± 1.6
Usual Care	10.3	± 2.1

Living Donor Kidney Transplant Concerns Secondary · Immediately post baseline, 1 month, 6 month, and 12 months

Developed specifically for this study as a measure of patients' concerns about LDKT. Questions were drawn from existing measures in the literature. We created a 6-item scale that captured concerns about LDKT including donation costs, evaluation process, function with a single kidney, poor outcome, and surgical risk as well as one question about access to deceased-donor kidney transplantation. Items are rated on a scale of 1 to 4, with the total score range 6 - 24. Higher scores indicate greater concerns about live kidney donation (a worse outcome).

Immediate

Group	Value	95% CI
KidneyTIME	10.7	± 3.0
Usual Care	11.2	± 3.0

1 Month

Group	Value	95% CI
KidneyTIME	11.1	± 1.2
Usual Care	11.6	± 3.1

6 Months

Group	Value	95% CI
KidneyTIME	11.2	± 2.9
Usual Care	11.9	± 2.8

12 Months

Group	Value	95% CI
KidneyTIME	10.9	± 3.3
Usual Care	11.7	± 2.8

Living Donor Kidney Transplant Readiness Secondary · Immediately post baseline, 1 month, 6 month, and 12 months

A measure of one's readiness for living-donor kidney transplantation. This 1-item scale measures the degree to which a person is ready for LDKT and is adapted from existing measures in the literature. Response options correspond to 5 stages of change based on the Transtheoretical Model and Stages of Change and are rated on a scale of 1 to 5 (minimum total value 1 and maximum total value 5) with higher scores indicating greater readiness (a better outcome).

Immediate

Group	Value	95% CI
KidneyTIME	2.7	± 1.1
Usual Care	2.5	± 1.2

1 Month

Group	Value	95% CI
KidneyTIME	2.8	± 1.0
Usual Care	1.7	± 1.1

6 Months

Group	Value	95% CI
KidneyTIME	2.8	± 1.1
Usual Care	2.6	± 1.1

12 Months

Group	Value	95% CI
KidneyTIME	2.8	± 1.3
Usual Care	2.7	± 1.3

Number of Participants With at Least One New Living Donor Kidney Transplant Access Behavior Secondary · Immediately post baseline, 1 month, 6 month, and 12 months

A measure to assess LDKT access behaviors. Patients were asked if they had done any of 5 transplant-related behaviors adapted from existing measures in the literature at baseline and at 1, 6, and 12 months. Statistical comparisons are based on Fisher's exact test. Proportions indicate at least one new behavior enacted after baseline.

Group	Value	95% CI
KidneyTIME	78
Usual Care	54

Active Placement on Kidney Transplant Waiting List Secondary · 12 months

Number of Participants with Active Placement on Kidney Transplant Waiting List

Group	Value	95% CI
KidneyTIME	105
Usual Care	113

Sponsor's own description

The study is a- 2-arm randomized controlled trial among patients presenting for kidney transplant evaluation at a single transplant center to compare the effects of a patient-based self-learning and outreach intervention about living-donor kidney transplantation (KidneyTIME) versus usual care for living-donor kidney transplant knowledge, concerns, readiness, access behaviors, and living-donor inquiries over 12 months follow-up. Following consent and baseline assessment, participants were randomized, stratified by self-reported race, with equal allocation to 2 treatment arms: the KidneyTIME intervention and usual care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Perspectives of a mobile intervention for kidney transplant seekers: Post-intervention qualitative results from the KidneyTIME study.
   Kayler LK, Solbu A, Keller M, Handmacher M, et al · · 2025 · PMID 40445961 · DOI 10.1371/journal.pone.0325313