Kidney FailureNCT03350269
Effect of Lost Wage Reimbursement to Kidney Donors on Living Donation Rates
A study testing Information provision in people with Kidney Failure and Surgery, run by Arbor Research Collaborative for Health at 6 sites in United States.
Trial summary
The study is designed as a randomized controlled trial. The investigators hypothesize that kidney transplant recipient candidates whose donors are offered reimbursement of lost wages (treatment arm) will have a higher probability of receiving a living donor kidney transplant than those randomized to no offer of lost… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Surgery, Renal Failure
- What is being tested?
- Information provision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,310 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Nov 2017to 20 Oct 2020
- 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
- Age ≥18 at enrollment
- Meet participating transplant center standards to initiate an evaluation to receive a kidney transplant
- Kidney-only or kidney intended to be followed by other organ (e.g. deceased donor pancreas)
- First-time recipient candidate
- Capable of providing informed consent
Who cannot join
- None
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Michigan Medicine - University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Denver, Colorado, 80045
UCLA Kidney and Pancreas Transplant Program in collaboration with the Transplant Research and Education Center (TREC)
Los Angeles, California, 90024
University of Minnesota
Minneapolis, Minnesota, 55455
Mt. Sinai Medical Center
New York, New York, 10029
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Randomized Controlled Trial to Evaluate the Effect of Lost Wage Reimbursement to Potential Kidney Donors On Living Donation Rates
The study is designed as a randomized controlled trial. The investigators hypothesize that kidney transplant recipient candidates whose donors are offered reimbursement of lost wages (treatment arm) will have a higher probability of receiving a living donor kidney transplant than those randomized to no offer of lost wage reimbursement (control arm). The study expects to demonstrate incremental living donor kidney transplants by assisting individuals who wish to be living organ donors but would be otherwise unable to do so due to the obligatory forfeit of income during the evaluation, donation surgery, and post-operative recuperation periods.
Read the detailed description
Following confirmation of eligibility and written informed consent to participate in the study, kidney recipient candidates will be randomized at the time of their evaluation appointment to the treatment arm (donor eligible for reimbursement of lost wages) or the control arm (donor not eligible for reimbursement of lost wages).
Consented, randomized recipients will be followed for up to one year from the baseline visit, with no required in-person visits beyond baseline. Data will be collected at baseline, six months after baseline, and one year after baseline. Demographic data (e.g. age, sex, race, ethnicity) will be collected on all recipients during screening and eligibility assessment. At baseline only, we will collect recipient household size, household income, and limited clinical data (on dialysis or not; date of dialysis initiation (if on dialysis); on deceased donor waiting list or not; date of wait-listing if on waiting list). At six months after baseline (and at one year after baseline, if applicable), we will collect recipient outcome data (date of receipt of living donor or deceased donor kidney transplant, if applicable; date of death, if applicable).
Demographic data (e.g. age, sex, race, ethnicity), household size, and household income will be collected on all potential donors that come forward for participating recipients, ideally as soon as they are known to the participating transplant center, and no later than six months after baseline and one year after baseline, if applicable). Administrative and financial data will be required only from the subset of donors meeting all of the following criteria:
- Donors whose recipients are randomized to the treatment arm; AND
- Donors who will incur lost wages and wish to receive lost wage reimbursement
A randomized controlled trial is the gold standard for program evaluation, since it allows for a statistical comparison of otherwise similar patients, and determination of a causal relationship between the intervention and the measured outcome. By comparing the outcomes of the control and treatment arms, we can determine whether the availability of reimbursement of lost wages for living donors increases the likelihood that the potential recipient will receive a living donor kidney within a year of their initial evaluation visit to a participating transplant center. We will also conduct secondary analyses of the timing of transplants and the demographics of the living donors.
- Conditions
- Kidney Failure, Surgery, Renal Failure
- Being tested
- Information provision
- Keywords
- Living kidney donation, Kidney transplant, Lost Wage Reimbursement
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information provisionOther
Kidney transplant recipients are informed that their donors may be eligible for lost wage reimbursement
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Kidney transplant recipient candidates who are informed that their living donor candidates can receive reimbursement for lost wages incurred during the evaluation, donation surgery and recuperation Receives: Other: Information provision |
| Control | No intervention | Kidney transplant recipient candidates who receive standard of care (donors are not offered wage reimbursement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of offering wage reimbursement on rate of living donor kidney transplant
Number of kidney transplant recipient candidates in intervention vs. control group who receive a living door transplant within one year of their first visit to the participating transplant center for evaluation as a potential kidney transplant recipient (time zero)
Measured: One year from time zero
Secondary outcomes (2)
Difference in time to outcome events (living donor transplant, deceased donor transplant, removal from transplant waiting list, death) between control group and intervention arm
Compare the effect of the program on recipient outcomes
Measured: Time zero to one year
Effect of offering donor wage reimbursement on demographic characteristics of living kidney donor pool
Compare demographic characteristics of donors in the control and intervention arms 's living kidney donor pool with national living kidney donor characteristics
Measured: Time zero to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start15 Nov 2017
- Primary completion17 Jun 2020
- Study completion20 Oct 2020
Why it stopped: Study was terminated prior to full enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Kidney FailureStudies 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
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 1,310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arbor Research Collaborative for Health
- Sponsor type
- University, hospital or other
- Collaborators
- Laura and John Arnold Foundation, American Society of Transplant Surgeons
- Responsible party
- Sponsor
- Investigators
- Kimberly A. Gifford, MBA, Principal investigator, American Society of Transplant SurgeonsJudd Kessler, PhD, Principal investigator, Wharton School, University of PennsylvaniaRobert M. Merion, MD, FACS, Principal investigator, Arbor Research Collaborative for HealthAmit K. Mathur, MD, Principal investigator, Mayo ClinicAkinlolu O. Ojo, MD, PhD, MBA, Principal investigator, University of Arizona Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350269
- Sponsor's protocol ID
- Kidney Donor Lost Wages Study
- Status last verified
- Jan 2020
- First submitted
- 14 Nov 2017
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study was terminated prior to full enrollment so there are no data to be shared
Publications
Agerskov H, Ludvigsen MS, Bistrup C, Pedersen BD. From donation to everyday life: Living kidney donors' experiences three months after donation. J Ren Care. 2016 Mar;42(1):43-52. doi: 10.1111/jorc.12137. Epub 2015 Oct 14.
PubMed 26463844Larson DB, Jacobs C, Berglund D, Wiseman J, Garvey C, Gillingham K, Ibrahim HN, Matas AJ. Return to normal activities and work after living donor laparoscopic nephrectomy. Clin Transplant. 2017 Jan;31(1). doi: 10.1111/ctr.12862. Epub 2016 Dec 22.
PubMed 27740731Clarke KS, Klarenbach S, Vlaicu S, Yang RC, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. The direct and indirect economic costs incurred by living kidney donors-a systematic review. Nephrol Dial Transplant. 2006 Jul;21(7):1952-60. doi: 10.1093/ndt/gfl069. Epub 2006 Mar 22.
PubMed 16554329Waterman AD, Covelli T, Caisley L, Zerega W, Schnitzler M, Adams D, Hong BA. Potential living kidney donors' health education use and comfort with donation. Prog Transplant. 2004 Sep;14(3):233-40. doi: 10.1177/152692480401400309.
PubMed 15495783Warren PH, Gifford KA, Hong BA, Merion RM, Ojo AO. Development of the National Living Donor Assistance Center: reducing financial disincentives to living organ donation. Prog Transplant. 2014 Mar;24(1):76-81. doi: 10.7182/pit2014593.
PubMed 24598569Rodrigue JR, Schold JD, Morrissey P, Whiting J, Vella J, Kayler LK, Katz D, Jones J, Kaplan B, Fleishman A, Pavlakis M, Mandelbrot DA; KDOC Study Group. Direct and Indirect Costs Following Living Kidney Donation: Findings From the KDOC Study. Am J Transplant. 2016 Mar;16(3):869-76. doi: 10.1111/ajt.13591. Epub 2016 Feb 4.
PubMed 26845630Rodrigue JR, Schold JD, Morrissey P, Whiting J, Vella J, Kayler LK, Katz D, Jones J, Kaplan B, Fleishman A, Pavlakis M, Mandelbrot DA; KDOC Study Group. Predonation Direct and Indirect Costs Incurred by Adults Who Donated a Kidney: Findings From the KDOC Study. Am J Transplant. 2015 Sep;15(9):2387-93. doi: 10.1111/ajt.13286. Epub 2015 May 5.
PubMed 25943721Rodrigue JR, Schold JD, Mandelbrot DA. The decline in living kidney donation in the United States: random variation or cause for concern? Transplantation. 2013 Nov 15;96(9):767-73. doi: 10.1097/TP.0b013e318298fa61.
PubMed 23759882Manyalich M, Ricart A, Martinez I, Balleste C, Paredes D, Vilardell J, Avsec D, Dias L, Fehrman-Eckholm I, Hiesse C, Kyriakides G, Line PD, Maxwell A, Nanni Costa A, Paez G, Turcu R, Walaszewski J. EULID project: European living donation and public health. Transplant Proc. 2009 Jul-Aug;41(6):2021-4. doi: 10.1016/j.transproceed.2009.05.021.
PubMed 19715823Pruett TL, Tibell A, Alabdulkareem A, Bhandari M, Cronin DC, Dew MA, Dib-Kuri A, Gutmann T, Matas A, McMurdo L, Rahmel A, Rizvi SA, Wright L, Delmonico FL. The ethics statement of the Vancouver Forum on the live lung, liver, pancreas, and intestine donor. Transplantation. 2006 May 27;81(10):1386-7. doi: 10.1097/01.tp.0000214976.36526.e3. No abstract available.
PubMed 16732173Collier R. Ontario and Manitoba to reimburse expenses for living organ donors. CMAJ. 2008 Jun 3;178(12):1535. doi: 10.1503/cmaj.080704. No abstract available.
PubMed 18519896Concejero AM, Chen CL. Ethical perspectives on living donor organ transplantation in Asia. Liver Transpl. 2009 Dec;15(12):1658-61. doi: 10.1002/lt.21930.
PubMed 19938130Hippen B, Matas A. Incentives for organ donation in the United States: feasible alternative or forthcoming apocalypse? Curr Opin Organ Transplant. 2009 Apr;14(2):140-6. doi: 10.1097/MOT.0b013e3283295e0d.
PubMed 19307965Howell E, Corder L, Dobson A. Out-of-pocket health expenses for Medicaid and other poor and near-poor persons in 1980. Natl Med Care Util Expend Surv B. 1985 Aug;(4):1-52.
PubMed 10313450Jotkowitz A. Notes on the new Israeli organ donation law-2008. Transplant Proc. 2008 Dec;40(10):3297-8. doi: 10.1016/j.transproceed.2008.08.128.
PubMed 19100375
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Effect of Lost Wage Reimbursement to Potential Kidney Donors On Living Donation Rates
- ClinicalTrials.gov ID
- NCT03350269
- Acronym / sponsor ID
- Kidney Donor Lost Wages Study
- Conditions
- Kidney Failure, Surgery, Renal Failure
- Keywords
- Living kidney donation, Kidney transplant, Lost Wage Reimbursement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated prior to full enrollment
- Enrolment
- 1,310 participants (actual)
- Lead sponsor
- Arbor Research Collaborative for HealthUniversity, hospital or other
- Collaborators
- Laura and John Arnold Foundation, American Society of Transplant Surgeons
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 17 Jun 2020 (actual)
- Study completion
- 20 Oct 2020 (actual)
- First posted
- 22 Nov 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.
The study is designed as a randomized controlled trial. The investigators hypothesize that kidney transplant recipient candidates whose donors are offered reimbursement of lost wages (treatment arm) will have a higher probability of receiving a living donor kidney transplant than those randomized to no offer of lost wage reimbursement (control arm). The study expects to demonstrate incremental living donor kidney transplants by assisting individuals who wish to be living organ donors but would be otherwise unable to do so due to the obligatory forfeit of income during the evaluation, donation surgery, and post-operative recuperation periods.
Detailed description
Following confirmation of eligibility and written informed consent to participate in the study, kidney recipient candidates will be randomized at the time of their evaluation appointment to the treatment arm (donor eligible for reimbursement of lost wages) or the control arm (donor not eligible for reimbursement of lost wages).
Consented, randomized recipients will be followed for up to one year from the baseline visit, with no required in-person visits beyond baseline. Data will be collected at baseline, six months after baseline, and one year after baseline. Demographic data (e.g. age, sex, race, ethnicity) will be collected on all recipients during screening and eligibility assessment. At baseline only, we will collect recipient household size, household income, and limited clinical data (on dialysis or not; date of dialysis initiation (if on dialysis); on deceased donor waiting list or not; date of wait-listing if on waiting list). At six months after baseline (and at one year after baseline, if applicable), we will collect recipient outcome data (date of receipt of living donor or deceased donor kidney transplant, if applicable; date of death, if applicable).
Demographic data (e.g. age, sex, race, ethnicity), household size, and household income will be collected on all potential donors that come forward for participating recipients, ideally as soon as they are known to the participating transplant center, and no later than six months after baseline and one year after baseline, if applicable). Administrative and financial data will be required only from the subset of donors meeting all of the following criteria:
- Donors whose recipients are randomized to the treatment arm; AND
- Donors who will incur lost wages and wish to receive lost wage reimbursement
A randomized controlled trial is the gold standard for program evaluation, since it allows for a statistical comparison of otherwise similar patients, and determination of a causal relationship between the intervention and the measured outcome. By comparing the outcomes of the control and treatment arms, we can determine whether the availability of reimbursement of lost wages for living donors increases the likelihood that the potential recipient will receive a living donor kidney within a year of their initial evaluation visit to a participating transplant center. We will also conduct secondary analyses of the timing of transplants and the demographics of the living donors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Information provisionKidney transplant recipient candidates who are informed that their living donor candidates can receive reimbursement for lost wages incurred during the evaluation, donation surgery and recuperation |
| Control | No intervention | –Kidney transplant recipient candidates who receive standard of care (donors are not offered wage reimbursement) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 at enrollment
- Meet participating transplant center standards to initiate an evaluation to receive a kidney transplant
- Kidney-only or kidney intended to be followed by other organ (e.g. deceased donor pancreas)
- First-time recipient candidate
- Capable of providing informed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Information provisionKidney transplant recipients are informed that their donors may be eligible for lost wage reimbursement | Other | Intervention |
Primary outcome
Effect of offering wage reimbursement on rate of living donor kidney transplant
Time frame: One year from time zero
Number of kidney transplant recipient candidates in intervention vs. control group who receive a living door transplant within one year of their first visit to the participating transplant center for evaluation as a potential kidney transplant recipient (time zero)
2 secondary outcomes
Difference in time to outcome events (living donor transplant, deceased donor transplant, removal from transplant waiting list, death) between control group and intervention arm
Time frame: Time zero to one year
Effect of offering donor wage reimbursement on demographic characteristics of living kidney donor pool
Time frame: Time zero to one year
Results and safety
The study was stopped early (reason given: Study was terminated prior to full enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Background: PubMed 26463844Agerskov H, Ludvigsen MS, Bistrup C, Pedersen BD. From donation to everyday life: Living kidney donors' experiences three months after donation. J Ren Care. 2016 Mar;42(1):43-52. doi: 10.1111/jorc.12137. Epub 2015 Oct 14.
- Background: PubMed 27740731Larson DB, Jacobs C, Berglund D, Wiseman J, Garvey C, Gillingham K, Ibrahim HN, Matas AJ. Return to normal activities and work after living donor laparoscopic nephrectomy. Clin Transplant. 2017 Jan;31(1). doi: 10.1111/ctr.12862. Epub 2016 Dec 22.
- Background: PubMed 16554329Clarke KS, Klarenbach S, Vlaicu S, Yang RC, Garg AX; Donor Nephrectomy Outcomes Research (DONOR) Network. The direct and indirect economic costs incurred by living kidney donors-a systematic review. Nephrol Dial Transplant. 2006 Jul;21(7):1952-60. doi: 10.1093/ndt/gfl069. Epub 2006 Mar 22.
- Background: PubMed 15495783Waterman AD, Covelli T, Caisley L, Zerega W, Schnitzler M, Adams D, Hong BA. Potential living kidney donors' health education use and comfort with donation. Prog Transplant. 2004 Sep;14(3):233-40. doi: 10.1177/152692480401400309.
- Background: PubMed 24598569Warren PH, Gifford KA, Hong BA, Merion RM, Ojo AO. Development of the National Living Donor Assistance Center: reducing financial disincentives to living organ donation. Prog Transplant. 2014 Mar;24(1):76-81. doi: 10.7182/pit2014593.
- Background: PubMed 26845630Rodrigue JR, Schold JD, Morrissey P, Whiting J, Vella J, Kayler LK, Katz D, Jones J, Kaplan B, Fleishman A, Pavlakis M, Mandelbrot DA; KDOC Study Group. Direct and Indirect Costs Following Living Kidney Donation: Findings From the KDOC Study. Am J Transplant. 2016 Mar;16(3):869-76. doi: 10.1111/ajt.13591. Epub 2016 Feb 4.
- Background: PubMed 25943721Rodrigue JR, Schold JD, Morrissey P, Whiting J, Vella J, Kayler LK, Katz D, Jones J, Kaplan B, Fleishman A, Pavlakis M, Mandelbrot DA; KDOC Study Group. Predonation Direct and Indirect Costs Incurred by Adults Who Donated a Kidney: Findings From the KDOC Study. Am J Transplant. 2015 Sep;15(9):2387-93. doi: 10.1111/ajt.13286. Epub 2015 May 5.
- Background: PubMed 23759882Rodrigue JR, Schold JD, Mandelbrot DA. The decline in living kidney donation in the United States: random variation or cause for concern? Transplantation. 2013 Nov 15;96(9):767-73. doi: 10.1097/TP.0b013e318298fa61.
- Background: PubMed 19715823Manyalich M, Ricart A, Martinez I, Balleste C, Paredes D, Vilardell J, Avsec D, Dias L, Fehrman-Eckholm I, Hiesse C, Kyriakides G, Line PD, Maxwell A, Nanni Costa A, Paez G, Turcu R, Walaszewski J. EULID project: European living donation and public health. Transplant Proc. 2009 Jul-Aug;41(6):2021-4. doi: 10.1016/j.transproceed.2009.05.021.
- Background: PubMed 16732173Pruett TL, Tibell A, Alabdulkareem A, Bhandari M, Cronin DC, Dew MA, Dib-Kuri A, Gutmann T, Matas A, McMurdo L, Rahmel A, Rizvi SA, Wright L, Delmonico FL. The ethics statement of the Vancouver Forum on the live lung, liver, pancreas, and intestine donor. Transplantation. 2006 May 27;81(10):1386-7. doi: 10.1097/01.tp.0000214976.36526.e3. No abstract available.
- Background: PubMed 18519896Collier R. Ontario and Manitoba to reimburse expenses for living organ donors. CMAJ. 2008 Jun 3;178(12):1535. doi: 10.1503/cmaj.080704. No abstract available.
- Background: PubMed 19938130Concejero AM, Chen CL. Ethical perspectives on living donor organ transplantation in Asia. Liver Transpl. 2009 Dec;15(12):1658-61. doi: 10.1002/lt.21930.
- Individual participant dataSharing planned: No. The study was terminated prior to full enrollment so there are no data to be shared
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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.
Kimberly A. Gifford, MBA principal investigator
American Society of Transplant Surgeons
Judd Kessler, PhD principal investigator
Wharton School, University of Pennsylvania
Robert M. Merion, MD, FACS principal investigator
Arbor Research Collaborative for Health
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information provision in people with Kidney Failure and Surgery, run by Arbor Research Collaborative for Health at 6 sites 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 5 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 was stopped early (reason given: Study was terminated prior to full enrollment). Results are not available in the source record.
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?
Effect of offering wage reimbursement on rate of living donor kidney transplant (time frame: One year from time zero). 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 NCT03350269, which also lists 23 linked publications.
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 3 Jan 2022.