Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT05519150
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2022-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'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': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D059349', 'term': 'Urine Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2022-08-26', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in eGFR and urine protein to urine creatinine ratio', 'timeFrame': '>2 years', 'description': 'To assess the changes in eGFR and urine protein to urine creatinine ratio in kidney donors with history of kidney stones who donated a kidney 2 or more years ago. We will compare these kidney donors with the age, sex, years since donation and body mass index matched standard (non-stone) kidney donors for absolute eGFR and protein/creatinine urine ratio change, using time as a denominator by paired t-test.'}], 'secondaryOutcomes': [{'measure': 'changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies', 'timeFrame': '>2 years', 'description': 'To compare the changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies in kidney donors with history of kidney stones compared to those who were rejected for donation due to abnormal urine studies or CT scan. We will compare pre-post 24-hour urine results for supersaturation of calcium oxalate, calcium phosphate, and uric acid (composite risks), and the individual parameters of urine volume, calcium, citrate, oxalate, uric acid and pH with paired t-test.'}, {'measure': 'assess formation of new kidney stones by imaging', 'timeFrame': '>2 years', 'description': 'To assess formation of new kidney stones by imaging. Kidney donors who consent will undergo a low dose radiation abdominal CT scan to identify new kidney stones in the remaining kidney. We will determine the number of symptomatic, passed, and asymptomatic kidney stones on CT scan post donation as a function of time.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transplant'], 'conditions': ['Kidney Stones']}, 'descriptionModule': {'briefSummary': 'We believe that kidney donors with kidney stones accepted for a donation do not have an increased risk of loss of kidney function and will not be at increased risk of symptomatic kidney stone events compared to donors without a history of kidney stones.', 'detailedDescription': "Indiana University Health center has a large nephrology and transplant service which is well versed in taking care of kidney donors with history of kidney stones. We believe that kidney donors with kidney stones accepted for a donation do not have an increased risk of loss of kidney function and will not be at increased risk of symptomatic kidney stone events compared to donors without a history of kidney stones. In this study we are contacting past kidney donors and participants with kidney stone who were declined as kidney donors. We will use blood tests, 24-hour urine tests, computed tomography (CT) scan, patient reported medical history and medical history in the patient's chart to gather data. This data will help us compare non stone donors, stone donors, and participants with kidney stone who were declined as kidney donors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '90 participants who were evaluated to donate a kidney at Indiana University (IU) School of Medicine /IU Health Transplant \\> 2 years ago.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18,\n* Evaluation for kidney donation \\> 2 years ago, with A) no history of kidney stones, or kidney stones on Imaging and successfully donated a kidney B) either had history of kidney stones or kidney stones on imaging and either i) successfully donated a kidney or ii) were declined for donation due to history of kidney stones, Litholink abnormalities or Imaging findings\n* Willing to participate and sign an informed consent.\n\nExclusion Criteria:\n\n* Subjects who are currently pregnant or breast feeding.'}, 'identificationModule': {'nctId': 'NCT05519150', 'acronym': 'DONATE', 'briefTitle': 'Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Donors With Nephrolithiasis at the Time of Transplant Evaluation (DONATE). Long Term Follow-up.', 'orgStudyIdInfo': {'id': '15048'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stone Donors', 'description': 'Evaluation for kidney donation \\> 2 years ago, had history of kidney stones or kidney stones on imaging and successfully donated a kidney', 'interventionNames': ['Diagnostic Test: low dose radiation abdomen/pelvis CT scan (stone protocol)', 'Procedure: Blood draw', 'Other: 24 hour urine collection']}, {'label': 'Denied donors', 'description': 'Evaluation for kidney donation \\> 2 years ago, had history of kidney stones or kidney stones on imaging and were declined for donation due to history of kidney stones, Litholink abnormalities or Imaging findings', 'interventionNames': ['Diagnostic Test: low dose radiation abdomen/pelvis CT scan (stone protocol)', 'Procedure: Blood draw', 'Other: 24 hour urine collection']}, {'label': 'Non-Stone Donors', 'description': 'Evaluation for kidney donation \\> 2 years ago, with no history of kidney stones, or kidney stones on Imaging and successfully donated a kidney', 'interventionNames': ['Diagnostic Test: low dose radiation abdomen/pelvis CT scan (stone protocol)', 'Procedure: Blood draw', 'Other: 24 hour urine collection']}], 'interventions': [{'name': 'low dose radiation abdomen/pelvis CT scan (stone protocol)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Kidney donors who consent will undergo a low dose radiation abdominal CT scan to identify new kidney stones in the remaining kidney. The will come to an IU Health Hospital for a low dose radiation abdomen/pelvis CT scan (stone protocol).', 'armGroupLabels': ['Denied donors', 'Non-Stone Donors', 'Stone Donors']}, {'name': 'Blood draw', 'type': 'PROCEDURE', 'description': 'To compare the changes changes in eGFR in evaluated kidney donors Blood will be draw by a trained phlebotomist.', 'armGroupLabels': ['Denied donors', 'Non-Stone Donors', 'Stone Donors']}, {'name': '24 hour urine collection', 'type': 'OTHER', 'description': 'To compare the changes in metabolic kidney stone risk parameters in 24-hour urine assessments to pre-donation urine studies in evaluated kidney donors.', 'armGroupLabels': ['Denied donors', 'Non-Stone Donors', 'Stone Donors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Clinical Medicine', 'investigatorFullName': 'Muhammad Yahya Jan', 'investigatorAffiliation': 'Indiana University'}}}}