End Stage Renal DiseaseNCT00805038
Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation
A study testing Transplant navigator in people with End Stage Renal Disease, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Transplant navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Feb 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old
- English speaking
- Mentally competent
Who cannot join
- Prior pre-transplant workup
- Prior kidney transplant
- Active systemic infection
- Active or recent malignancy
Trial locations and contacts
1 site in 1 country.
About this study
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 as they together make transplant-related decisions. Future work will involve determining the impact of navigators on disparities in transplant rates, examining the cost-effectiveness of transplant navigators, and disseminating the intervention for use across the country. Helping patients complete steps in the transplant process may lead not only to improved access to kidney transplantation but also to better patient survival, decreased health care costs, and increased quality of life.
- Conditions
- End Stage Renal Disease
- Being tested
- Transplant navigator, Usual care
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplant navigatorBehavioural
Also called Control: usual care
Navigator will provide help to patients in completing specific steps in transplant process.
Usual careBehavioural
Nephrologists and dialysis facilities will provide usual care regarding access to transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Usual care Receives: Behavioral: Usual care |
| Intervention | Experimental | Navigator will assist patients in completing steps in transplant process Receives: Behavioral: Transplant navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Steps Completed in Transplant Process
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.
Measured: 18-24 months
Secondary outcomes (1)
Impediments to Successful Intervention
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ash Sehgal, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805038
- Sponsor's protocol ID
- IRB07-00301
- Status last verified
- Sep 2025
- First submitted
- 8 Dec 2008
- Last updated
- 23 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.
PubMed 36472416
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplant Navigator Intervention to Overcome Barriers to Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00805038
- Acronym / sponsor ID
- IRB07-00301
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Posted 15 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 as they together make transplant-related decisions. Future work will involve determining the impact of navigators on disparities in transplant rates, examining the cost-effectiveness of transplant navigators, and disseminating the intervention for use across the country. Helping patients complete steps in the transplant process may lead not only to improved access to kidney transplantation but also to better patient survival, decreased health care costs, and increased quality of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Usual careUsual care |
| Intervention | Experimental | Behavioral: Transplant navigatorNavigator will assist patients in completing steps in transplant process |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70 years old
- English speaking
- Mentally competent
Key exclusion criteria (4 listed)
- Prior pre-transplant workup
- Prior kidney transplant
- Active systemic infection
- Active or recent malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transplant navigatorAlso: Control: usual careNavigator will provide help to patients in completing specific steps in transplant process. | Behavioural | Intervention |
| Usual careNephrologists and dialysis facilities will provide usual care regarding access to transplantation. | Behavioural | Control |
Primary outcome
Number of Steps Completed in Transplant Process
Time frame: 18-24 months
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.
1 secondary outcome
Impediments to Successful Intervention
Time frame: 18-24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36472416Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ash Sehgal, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transplant navigator in people with End Stage Renal Disease, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Steps Completed in Transplant Process (time frame: 18-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00805038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.