Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-03 @ 6:45 PM
Study NCT ID:
NCT04798092
Status:
UNKNOWN
Last Update Posted:
2022-12-05
First Post:
2021-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Parathyroidectomy on Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049950', 'term': 'Hyperparathyroidism, Primary'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016105', 'term': 'Parathyroidectomy'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-02', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in renal function', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'glomerular filtration rate (CKD in mL/min)'}], 'secondaryOutcomes': [{'measure': 'Change in calcium', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Blood calcium level (in mg/L)'}, {'measure': 'Change in parathormone', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Blood parathormone level (in ng/dL)'}, {'measure': 'Change in vitamin D', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Blood vitamine D level (in ng/mL)'}, {'measure': 'Change in urinary calcium', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Urine calcium level (in mg/24h)'}, {'measure': 'Change in insulin', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Fasting blood insuline level (in mUI/L)'}, {'measure': 'Change in glycemia', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Fasting blood glucose level (in g/L)'}, {'measure': 'Change in osteocalcin', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Blood osteocalcin level (in ng/mL)'}, {'measure': 'Change in bone alkaline phosphatases', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Blood bone alkaline phosphatases level (in microgr/L)'}, {'measure': 'Change in aldosterone', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Blood aldosterone level (in pg/mL)'}, {'measure': 'Change in renin', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Blood active renin (in pg/mL)'}, {'measure': 'Change in total cholesterol', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Blood total cholesterol (in gr/L)'}, {'measure': 'Change in HDL cholesterol', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Blood HDL Cholesterol (in gr/L)'}, {'measure': 'Change in LDL cholesterol', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Blood LDL Cholesterol (in gr/L)'}, {'measure': 'Change in triglycerides', 'timeFrame': 'preoperative, postoperative at 3, 6, and 12 months', 'description': 'Blood triglycerides (in gr/L)'}, {'measure': 'CAC scoring on CT scan', 'timeFrame': 'preoperative', 'description': 'CAC score (actual value)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Hyperparathyroidism', 'Renal function'], 'conditions': ['Primary Hyperparathyroidism']}, 'descriptionModule': {'briefSummary': 'Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.', 'detailedDescription': 'Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.\n\nCriteria are detailled in "Outcomes measures"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing parathyroidectomy for primary hyperparathyroidism with surgical cure defined as postoperative normocalciemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- patients undergoing parathyroidectomy for primary hyperparathyroidism with surgical cure defined as postoperative normocalciemia\n\nExclusion Criteria:\n\n* patients on dialysis\n* GFR \\< 15 ml/min\n* renal graft'}, 'identificationModule': {'nctId': 'NCT04798092', 'acronym': 'PARA-REIN', 'briefTitle': 'Impact of Parathyroidectomy on Renal Function', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Impact of Parathyroidectomy on Renal Function in Patients With Primary Hyperparathyroidism', 'orgStudyIdInfo': {'id': '2020PI099'}}, 'armsInterventionsModule': {'interventions': [{'name': 'parathyroidectomy', 'type': 'PROCEDURE', 'description': 'surgical removal of parathyroid adenoma(s) with postoperative biological cure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Lorraine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Brunaud', 'role': 'CONTACT', 'email': 'l.brunaud@chru-nancy.fr'}], 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'laurent Brunaud', 'role': 'CONTACT', 'email': 'l.brunaud@chru-nancy.fr'}], 'overallOfficials': [{'name': 'Brunaud', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU NANCY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}