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NCT00805038 · ClinicalTrials.gov registry record · NA

Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation

A NA study, sponsored by Case Western Reserve University.

Completed
Registry status
NA
Development phase
167
Enrollment target

NCT00805038: Completed NA study, sponsored by Case Western Reserve University.

NCT00805038 is a NA study that has completed, run by Case Western Reserve University. The registered enrollment target is 167 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00805038, a NA study, has completed, sponsored by Case Western Reserve University.

COMPLETED
Registry status
NA
Development phase
167 participants
Enrollment target

Study Summary

Compared with chronic dialysis treatment, kidney transplantation generally offers a longer life span, a better quality of life, and lower health care costs for the over 500,000 Americans with End Stage Renal Disease. Despite Medicare funding of virtually all kidney transplants, minority, female, and poor patients with End Stage Renal Disease have decreased access to kidney transplantation. In prior work, the investigators identified the steps in the transplant process that are responsible for creating these disparities. These include medical suitability, interest in receiving a transplant, referral to a transplant center for a pre-transplant workup, placement on a waiting list or identification of a living donor, and receipt of a kidney from a deceased or living donor. The investigators now propose to train transplant recipients to act as transplant navigators and then test the value of using transplant navigators to help patients and providers complete these steps. The proposed community-based randomized controlled trial will involve approximately 75-100 adult hemodialysis patients at intervention dialysis facilities and approximately 75-100 patients at control facilities to compare a transplant navigator intervention with usual care over a 24 month interval. Baseline evaluation will include sociodemographic and medical characteristics, specific steps completed in the transplant process, and barriers to moving forward in the transplant process. At periodic intervals, the navigator will provide tailored information and assistance to patients and their nephrologists to help them complete the tasks required at each step. The major outcome will be completion of additional steps in the transplant process. Secondary analyses will examine impediments to successful intervention among subjects who fail to move forward in the transplant process despite assistance from a navigator. The proposed project will test a novel intervention that targets patients and nephrologists a

Primary Outcome

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.

Interventions

  • BEHAVIORAL Usual care
  • BEHAVIORAL Transplant navigator

Trial Details

FieldValue
Enrollment Target 167 participants
Start Date 2009-01
Est. Completion 2011-02
Phase NA
Case Western Reserve University

141 total trials

What the finished NCT00805038 record still lists

NCT00805038 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).

The record links to 0 conditions, and to 2 interventions - of which Usual care is the first listed.

NCT00805038 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00805038 about?

NCT00805038 is a clinical study titled "Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation". Compared with chronic dialysis treatment, kidney transplantation generally offers a longer life span, a better quality of life, and lower health care costs for the over 500,000 Americans with End Stage Renal Disease. Despite Medicare funding of virtually all kidney transplants, minority, female, and...

What is the current status of trial NCT00805038?

This trial is currently completed. It is a NA study. The enrollment target is 167 participants. The study started on 2009-01. Estimated completion is 2011-02.

What interventions are being tested in trial NCT00805038?

The interventions under investigation include: Usual care (BEHAVIORAL), Transplant navigator (BEHAVIORAL).

Who is sponsoring clinical trial NCT00805038?

This trial is sponsored by Case Western Reserve University, which has 141 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00805038's enrollment target sits among peer trials

167 622nd of 2000 higher than 1,376 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00805038, the US trial registry maintained by the National Library of Medicine. NCT00805038 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.