Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-05 @ 10:34 PM
Study NCT ID:
NCT03350269
Status:
TERMINATED
Last Update Posted:
2022-01-03
First Post:
2017-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lost Wage Reimbursement to Kidney Donors on Living Donation Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-11', 'size': 825575, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-06-08T11:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1310}}, 'statusModule': {'whyStopped': 'Study was terminated prior to full enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2017-11-14', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of offering wage reimbursement on rate of living donor kidney transplant', 'timeFrame': 'One year from time zero', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Difference in time to outcome events (living donor transplant, deceased donor transplant, removal from transplant waiting list, death) between control group and intervention arm', 'timeFrame': 'Time zero to one year', 'description': 'Compare the effect of the program on recipient outcomes'}, {'measure': 'Effect of offering donor wage reimbursement on demographic characteristics of living kidney donor pool', 'timeFrame': 'Time zero to one year', 'description': "Compare demographic characteristics of donors in the control and intervention arms 's living kidney donor pool with national living kidney donor characteristics"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Living kidney donation', 'Kidney transplant', 'Lost Wage Reimbursement'], 'conditions': ['Kidney Failure', 'Surgery', 'Renal Failure']}, 'referencesModule': {'references': [{'pmid': '26463844', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '27740731', 'type': 'BACKGROUND', 'citation': 'Larson 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.'}, {'pmid': '16554329', 'type': 'BACKGROUND', 'citation': 'Clarke 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.'}, {'pmid': '15495783', 'type': 'BACKGROUND', 'citation': "Waterman 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."}, {'pmid': '24598569', 'type': 'BACKGROUND', 'citation': 'Warren 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.'}, {'pmid': '26845630', 'type': 'BACKGROUND', 'citation': 'Rodrigue 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.'}, {'pmid': '25943721', 'type': 'BACKGROUND', 'citation': 'Rodrigue 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.'}, {'pmid': '23759882', 'type': 'BACKGROUND', 'citation': 'Rodrigue 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.'}, {'pmid': '19715823', 'type': 'BACKGROUND', 'citation': 'Manyalich 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.'}, {'pmid': '16732173', 'type': 'BACKGROUND', 'citation': 'Pruett 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.'}, {'pmid': '18519896', 'type': 'BACKGROUND', 'citation': 'Collier 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.'}, {'pmid': '19938130', 'type': 'BACKGROUND', 'citation': 'Concejero 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.'}, {'pmid': '19307965', 'type': 'BACKGROUND', 'citation': 'Hippen 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.'}, {'pmid': '10313450', 'type': 'BACKGROUND', 'citation': 'Howell 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.'}, {'pmid': '19100375', 'type': 'BACKGROUND', 'citation': 'Jotkowitz 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.'}, {'pmid': '11271334', 'type': 'BACKGROUND', 'citation': 'Price D. Living kidney donation in Europe: legal and ethical perspectives--the EUROTOLD Project. Transpl Int. 1994;7 Suppl 1:S665-7. doi: 10.1111/j.1432-2277.1994.tb01468.x.'}, {'pmid': '19422754', 'type': 'BACKGROUND', 'citation': 'Rithalia A, McDaid C, Suekarran S, Norman G, Myers L, Sowden A. A systematic review of presumed consent systems for deceased organ donation. Health Technol Assess. 2009 May;13(26):iii, ix-xi, 1-95. doi: 10.3310/hta13260.'}, {'pmid': '19469028', 'type': 'BACKGROUND', 'citation': 'Rizvi AH, Naqvi AS, Zafar NM, Ahmed E. Regulated compensated donation in Pakistan and Iran. Curr Opin Organ Transplant. 2009 Apr;14(2):124-8. doi: 10.1097/mot.0b013e328326f6ef.'}, {'pmid': '19624568', 'type': 'BACKGROUND', 'citation': 'Rodrigue JR, Crist K, Roberts JP, Freeman RB Jr, Merion RM, Reed AI. Stimulus for organ donation: a survey of the American Society of Transplant Surgeons membership. Am J Transplant. 2009 Sep;9(9):2172-6. doi: 10.1111/j.1600-6143.2009.02741.x. Epub 2009 Jul 16.'}, {'pmid': '19039887', 'type': 'BACKGROUND', 'citation': 'Vlaicu S, Klarenbach S, Yang RC, Dempster T, Garg AX. Current Canadian initiatives to reimburse live organ donors for their non-medical expenses. Can J Public Health. 2007 Nov-Dec;98(6):481-3. doi: 10.1007/BF03405443.'}, {'pmid': '15478883', 'type': 'BACKGROUND', 'citation': 'Sells R. Incentives for organ donation: some ethical issues. Ann Transplant. 2004;9(1):23-4.'}, {'pmid': '17711405', 'type': 'BACKGROUND', 'citation': 'Schulz-Baldes A, Delmonico FL. Improving institutional fairness to live kidney donors: donor needs must be addressed by safeguarding donation risks and compensating donation costs. Transpl Int. 2007 Nov;20(11):940-6. doi: 10.1111/j.1432-2277.2007.00542.x. Epub 2007 Aug 17.'}, {'pmid': '14529850', 'type': 'BACKGROUND', 'citation': 'Wolters HH, Heidenreich S, Senninger N. Living donor kidney transplantation: chance for the recipient--financial risk for the donor? Transplant Proc. 2003 Sep;35(6):2091-2. doi: 10.1016/s0041-1345(03)00675-4.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nConsented, 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).\n\nDemographic 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:\n\n* Donors whose recipients are randomized to the treatment arm; AND\n* Donors who will incur lost wages and wish to receive lost wage reimbursement\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 at enrollment\n* Meet participating transplant center standards to initiate an evaluation to receive a kidney transplant\n* Kidney-only or kidney intended to be followed by other organ (e.g. deceased donor pancreas)\n* First-time recipient candidate\n* Capable of providing informed consent\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03350269', 'briefTitle': 'Effect of Lost Wage Reimbursement to Kidney Donors on Living Donation Rates', 'organization': {'class': 'OTHER', 'fullName': 'Arbor Research Collaborative for Health'}, 'officialTitle': 'Randomized Controlled Trial to Evaluate the Effect of Lost Wage Reimbursement to Potential Kidney Donors On Living Donation Rates', 'orgStudyIdInfo': {'id': 'Kidney Donor Lost Wages Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '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', 'interventionNames': ['Other: Information provision']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Kidney transplant recipient candidates who receive standard of care (donors are not offered wage reimbursement)'}], 'interventions': [{'name': 'Information provision', 'type': 'OTHER', 'description': 'Kidney transplant recipients are informed that their donors may be eligible for lost wage reimbursement', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Kidney and Pancreas Transplant Program in collaboration with the Transplant Research and Education Center (TREC)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Medicine - University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Kimberly A. Gifford, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Society of Transplant Surgeons'}, {'name': 'Judd Kessler, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wharton School, University of Pennsylvania'}, {'name': 'Robert M. Merion, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arbor Research Collaborative for Health'}, {'name': 'Amit K. Mathur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Akinlolu O. Ojo, MD, PhD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study was terminated prior to full enrollment so there are no data to be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbor Research Collaborative for Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Laura and John Arnold Foundation', 'class': 'OTHER'}, {'name': 'American Society of Transplant Surgeons', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}