Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-27 @ 10:14 PM
Study NCT ID:
NCT03676361
Status:
WITHDRAWN
Last Update Posted:
2019-05-20
First Post:
2018-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Renal Tubular Function Pre and Post Nephrectomy in Living Donors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003894', 'term': 'Deamino Arginine Vasopressin'}], 'ancestors': [{'id': 'D001127', 'term': 'Arginine Vasopressin'}, {'id': 'D014667', 'term': 'Vasopressins'}, {'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Not initiated', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-16', 'studyFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change in tubular function (urine osmolality measured in MOSMOL/K) pre and post nephrectomy as assessed through water deprivation and administration of desmopressin.', 'timeFrame': '6 months', 'description': 'Tubular function is measured as maximal urine concentrating capacity reached after water deprivation and administration of desmopressin.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of serum creatinine when compared to change in tubular function, pre and post nephrectomy as measured in MG/DL.', 'timeFrame': '6 months', 'description': "To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used"}, {'measure': 'Sensitivity of urine albumin excretion when compared to change in tubular function, pre and post nephrectomy as measured in MCG/ML.', 'timeFrame': '6 months', 'description': "To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used"}, {'measure': 'Sensitivity of eGFR when compared to change in tubular function, pre and post nephrectomy as measured in mL/min.', 'timeFrame': '6 months', 'description': "To test correlations between biomarkers all variables will be log-normalized and Pearson's regression analysis will be used"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney Damage'], 'conditions': ['Kidney Damage']}, 'descriptionModule': {'briefSummary': 'The overall goals of this study are to demonstrate the change in renal tubular function in living donors pre and post nephrectomy at 6 months.', 'detailedDescription': 'The physiologic sequelae of living kidney donation are still poorly understood. Uni-nephrectomy from donation results in decreased number of glomeruli and research has shown that there is glomerular hyperfiltration and glomerular hypertrophy. Uni-nephrectomy also results in a decreased number of tubules, but there is not much data about possible tubular injury post donation and its long term effects on donors.\n\nOur overall hypothesis is that post uni-nephrectomy tubular function, measured by maximum urine concentration capacity, will be decreased and may be a more sensitive marker of kidney damage than standard tests, such as urine albumin, serum creatinine, estimated glomerular filtration rate (eGFR), or measured urine creatinine clearance (CrCl). The goal of this study is to evaluate the effect of uni-nephrectomy on renal tubular function and its potential in being an early and more sensitive marker in kidney injury when compared to standard tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult ≥18 years of age, who has been evaluated and approved as a potential living donor by the multi-disciplinary committee. All donors undergo a standard medical, social, and psychological pre- donation assessment\n* Only patients who are able to sign their own consent form may be included in this study.\n* Subjects must be able and willing, in the investigator's opinion, to complete all study requirements.\n\nExclusion Criteria:\n\n* Subjects denied for donation for any medical, social or surgical reason to be living donor.\n* Patients who are contraindicated or relatively contraindicated for DDAVP: a. patients with von Willebrand disease; b. Patients with habitual or psychogenic polydipsia; c. Patients with coronary artery insufficiency and/or hypertensive cardiovascular disease; d. Patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure, and renal disorders; e. Patients predisposed to thrombus formation"}, 'identificationModule': {'nctId': 'NCT03676361', 'briefTitle': 'To Evaluate the Renal Tubular Function Pre and Post Nephrectomy in Living Donors', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'To Evaluate the Renal Tubular Function Pre and Post Nephrectomy in Living Donors', 'orgStudyIdInfo': {'id': 'STUDY00142279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desmopressin', 'description': 'All ten subjects will be evaluated pre and post nephrectomy at 6 months.', 'interventionNames': ['Drug: Desmopressin']}], 'interventions': [{'name': 'Desmopressin', 'type': 'DRUG', 'description': 'Subjects will complete a water deprivation test using desmopressin to aid in the determination of maximum tubular concentration capacity before and six months after uni-nephrectomy.', 'armGroupLabels': ['Desmopressin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Pooja Budhiraja, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Pooja Budhiraja, MD', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}