Trial Outcomes & Findings for Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation (NCT NCT00805038)

Results Overview

Many kidney failure patients, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These sequential steps include: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. We calculated the number of transplant process steps completed by both groups.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

167 participants

Primary outcome timeframe

18-24 months

Results posted on

2025-09-23

Participant Flow

Participant milestones

Participant milestones
Measure	Usual Care Usual care received by participants	Transplant Navigator Navigator will assist patients in completing steps in transplant process
Overall Study STARTED	75	92
Overall Study COMPLETED	75	92
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care n=75 Participants Usual care received by participants	Transplant Navigator n=92 Participants Navigator will assist patients in completing steps in transplant process	Total n=167 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	57 Participants n=93 Participants	84 Participants n=4 Participants	141 Participants n=27 Participants
Age, Categorical >=65 years	18 Participants n=93 Participants	8 Participants n=4 Participants	26 Participants n=27 Participants
Age, Continuous	57 years STANDARD_DEVIATION 9 • n=93 Participants	54 years STANDARD_DEVIATION 10 • n=4 Participants	56 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	28 Participants n=93 Participants	45 Participants n=4 Participants	73 Participants n=27 Participants
Sex: Female, Male Male	47 Participants n=93 Participants	47 Participants n=4 Participants	94 Participants n=27 Participants
Region of Enrollment United States	75 participants n=93 Participants	92 participants n=4 Participants	167 participants n=27 Participants

PRIMARY outcome

Timeframe: 18-24 months

Population: ITT analysis. Last observation carried forward for preliminary analyses.

Many kidney failure patients, particularly minorities and women, face barriers in completing the steps required to obtain a transplant. These sequential steps include: medical suitability, interest in transplant, referral to a transplant center, first visit to center, transplant workup, successful candidate, waiting list or identify living donor, and receive transplant. We calculated the number of transplant process steps completed by both groups.

Outcome measures

Outcome measures
Measure	Usual Care n=75 Participants Usual care received by participants	Transplant Navigator n=92 Participants Navigator will assist patients in completing steps in transplant process
Number of Steps Completed in Transplant Process	1.0 steps per participant Interval 0.6 to 1.4	2.8 steps per participant Interval 2.4 to 3.2

SECONDARY outcome

Timeframe: 18-24 months

Outcome measures

Outcome data not reported

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Transplant Navigator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ash Sehgal

Case Western Reserve University

Phone: 216-778-7728

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place