Kidney DiseasesNCT03268850
Living Kidney Donor Lost Wages Trial
A study testing Wage Reimbursement A and Wage Reimbursement B in people with Kidney Diseases, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study aims to evaluate the effectiveness of offering reimbursement for living donor lost wages on the rate of live donor kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Wage Reimbursement A and Wage Reimbursement B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For KT patients:
- Chronic Kidney Disease (CKD) stage 4/5
- Approved for kidney transplant (KT) listing or active on KT waiting list
- For patients listed at multiple centers: primary listing at Beth Israel Deaconess Medical Center (BIDMC)
- For LDs:
- Their KT candidate is enrolled in the trial
Who cannot join
- For KT patients:
- KT candidate has a potential LD approved, with surgery scheduled
- Listed for multi-organ transplantation
- Temporarily unavailable (TU) status on KT waiting list
- Current enrollment in another study to increase LDKT likelihood
- For LDs:
- Not residing in the US
Trial locations and contacts
1 site in 1 country.
United States1 site
BIDMC Transplant Center
Boston, Massachusetts, 02215
About this study
Official title: Living Donor Lost Wages Trial
This study aims to evaluate the effectiveness of offering reimbursement for living donor lost wages on the rate of live donor kidney transplantation.
Read the detailed description
Live donor kidney transplantation (LDKT) accelerates the path to transplantation and yields superior outcomes compared to dialysis and deceased donor kidney transplantation (KT). However, the annual number of LDKTs has declined over the last decade, particularly among minority and low-income patients. The investigators hypothesize, and have preliminary data to support, that the financial impact on living donors (LDs) is a major contributor to the LDKT decline and for persistent racial disparities in LDKT rates. Many LDs have substantial non-reimbursed direct and indirect costs, most notably the loss of income or wages following surgery. In this study, the investigators will: (1) evaluate the effectiveness of offering reimbursement for LD lost wages on the LDKT rate; (2) examine whether offering reimbursement for LD lost wages reduces known racial disparities in LDKT; and (3) determine whether study outcomes differ significantly by maximum reimbursement amount for LD lost wages.
- Conditions
- Kidney Diseases
- Being tested
- Standard of Care, Wage Reimbursement A, Wage Reimbursement B
- Keywords
- LDKT, Live donor transplantation, Kidney transplantation
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
All patients participating in the study will continue to receive usual care. Kidney transplant (KT) candidates are advised that live donor kidney transplantation (LDKT) is their best treatment option and are encouraged to initiate living donor (LD) discussions with family members and friends.
Wage Reimbursement ABehavioural
Enrolled KT candidates will be informed that, in addition to the National Living Donor Assistance Center (NLDAC) program, their LD may be eligible to receive reimbursement for wages lost during the donation recovery period - up to a certain amount, based on randomization. They will be given information describing the LW program, eligibility criteria, and application process to share with potential LDs. At the time of study enrollment, KT candidates will consent to the LD nurse coordinator informing all of their potential LDs about the study and the potential for reimbursement of LD lost wages.
Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria.
Wage Reimbursement BBehavioural
Enrolled KT candidates will be informed that, in addition to the National Living Donor Assistance Center (NLDAC) program, their LD may be eligible to receive reimbursement for wages lost during the donation recovery period - up to a certain amount (different from LW-A), based on randomization. They will be given information describing the LW program, eligibility criteria, and application process to share with potential LDs. At the time of study enrollment, KT candidates will consent to the LD nurse coordinator informing all of their potential LDs about the study and the potential for reimbursement of LD lost wages.
Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria.
| Study group | Role | What they receive |
|---|---|---|
| LW-A | Experimental | The Lost Wages A (LW-A) arm will be composed of kidney transplant patients meeting the inclusion criteria. This arm allows for possible wage reimbursement of living donor lost wages up to a certain amount. This will also include standard of care. Receives: Other: Standard of Care; Behavioral: Wage Reimbursement A |
| LW-B | Experimental | The Lost Wages B (LW-B) arm will be composed of kidney transplant patients meeting the inclusion criteria. This arm allows for possible wage reimbursement of living donor lost wages up to a different amount. This will also include standard of care. Receives: Other: Standard of Care; Behavioral: Wage Reimbursement B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of wage reimbursement on LDKT rate
LDKT rate in KT candidates compared to historical matched control group
Measured: 1 year
Effect of wage reimbursement on racial disparities in LDKT
LDKT rate among minorities
Measured: 1 year
Difference between reimbursement arms
LDKT rate in KT candidates in LW-A arm as compared to LDKT rate in KT candidates in LW-B arm
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start5 Feb 2018
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Candidates will be randomized 1:1 to the LW-A or LW-B arm, with stratification for race. The investigators will prepare the randomization schedule using permuted blocks of randomly varying size to limit predictability and imbalances in arm assignment throughout the study. KT candidates will be informed of group assignment immediately after consenting to the study.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Rodrigue, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268850
- Sponsor's protocol ID
- 2017P000213
- Status last verified
- Mar 2024
- First submitted
- 22 Aug 2017
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Donor Lost Wages Trial
- ClinicalTrials.gov ID
- NCT03268850
- Acronym / sponsor ID
- 2017P000213
- Conditions
- Kidney Diseases
- Keywords
- LDKT, Live donor transplantation, Kidney transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of offering reimbursement for living donor lost wages on the rate of live donor kidney transplantation.
Detailed description
Live donor kidney transplantation (LDKT) accelerates the path to transplantation and yields superior outcomes compared to dialysis and deceased donor kidney transplantation (KT). However, the annual number of LDKTs has declined over the last decade, particularly among minority and low-income patients. The investigators hypothesize, and have preliminary data to support, that the financial impact on living donors (LDs) is a major contributor to the LDKT decline and for persistent racial disparities in LDKT rates. Many LDs have substantial non-reimbursed direct and indirect costs, most notably the loss of income or wages following surgery. In this study, the investigators will: (1) evaluate the effectiveness of offering reimbursement for LD lost wages on the LDKT rate; (2) examine whether offering reimbursement for LD lost wages reduces known racial disparities in LDKT; and (3) determine whether study outcomes differ significantly by maximum reimbursement amount for LD lost wages.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Candidates will be randomized 1:1 to the LW-A or LW-B arm, with stratification for race. The investigators will prepare the randomization schedule using permuted blocks of randomly varying size to limit predictability and imbalances in arm assignment throughout the study. KT candidates will be informed of group assignment immediately after consenting to the study.
| Arm | Type | Receives |
|---|---|---|
| LW-A | Experimental | Other: Standard of Care, Behavioral: Wage Reimbursement AThe Lost Wages A (LW-A) arm will be composed of kidney transplant patients meeting the inclusion criteria. This arm allows for possible wage reimbursement of living donor lost wages up to a certain amount. This will also include standard of care. |
| LW-B | Experimental | Other: Standard of Care, Behavioral: Wage Reimbursement BThe Lost Wages B (LW-B) arm will be composed of kidney transplant patients meeting the inclusion criteria. This arm allows for possible wage reimbursement of living donor lost wages up to a different amount. This will also include standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For KT patients:
- Chronic Kidney Disease (CKD) stage 4/5
- Approved for kidney transplant (KT) listing or active on KT waiting list
- For patients listed at multiple centers: primary listing at Beth Israel Deaconess Medical Center (BIDMC)
- For LDs:
Key exclusion criteria (7 listed)
- For KT patients:
- KT candidate has a potential LD approved, with surgery scheduled
- Listed for multi-organ transplantation
- Temporarily unavailable (TU) status on KT waiting list
- Current enrollment in another study to increase LDKT likelihood
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 |
|---|---|---|
| Standard of CareAll patients participating in the study will continue to receive usual care. Kidney transplant (KT) candidates are advised that live donor kidney transplantation (LDKT) is their best treatment option and are encouraged to initiate living donor (LD) discussions with family members and friends. | Other | LW-A, LW-B |
| Wage Reimbursement AEnrolled KT candidates will be informed that, in addition to the National Living Donor Assistance Center (NLDAC) program, their LD may be eligible to receive reimbursement for wages lost during the donation recovery period - up to a certain amount, based on randomization. They will be given information describing the LW program, eligibility criteria, and application process to share with potential LDs. At the time of study enrollment, KT candidates will consent to the LD nurse coordinator informing all of their potential LDs about the study and the potential for reimbursement of LD lost wages. Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria. | Behavioural | LW-A |
| Wage Reimbursement BEnrolled KT candidates will be informed that, in addition to the National Living Donor Assistance Center (NLDAC) program, their LD may be eligible to receive reimbursement for wages lost during the donation recovery period - up to a certain amount (different from LW-A), based on randomization. They will be given information describing the LW program, eligibility criteria, and application process to share with potential LDs. At the time of study enrollment, KT candidates will consent to the LD nurse coordinator informing all of their potential LDs about the study and the potential for reimbursement of LD lost wages. Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria. | Behavioural | LW-B |
Primary outcome
Effectiveness of wage reimbursement on LDKT rate
Time frame: 1 year
LDKT rate in KT candidates compared to historical matched control group
Effect of wage reimbursement on racial disparities in LDKT
Time frame: 1 year
LDKT rate among minorities
Difference between reimbursement arms
Time frame: 1 year
LDKT rate in KT candidates in LW-A arm as compared to LDKT rate in KT candidates in LW-B arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wage Reimbursement A and Wage Reimbursement B in people with Kidney Diseases, run by Beth Israel Deaconess Medical Center 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 6 inclusion and 7 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 18 Mar 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effectiveness of wage reimbursement on LDKT rate (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2024.