Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT01178450
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2010-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D006934', 'term': 'Hypercalcemia'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016105', 'term': 'Parathyroidectomy'}, {'id': 'D000069449', 'term': 'Cinacalcet'}], 'ancestors': [{'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2010-04-19', 'studyFirstSubmitQcDate': '2010-08-09', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood calcium levels', 'timeFrame': '12 months', 'description': 'Change from baseline in blood calcium levels at 12 months.'}], 'secondaryOutcomes': [{'measure': 'Change in parathyrin blood levels', 'timeFrame': '12 months', 'description': 'Change from baseline in parathyrin blood levels at 12 months.'}, {'measure': 'Patient and graft survival', 'timeFrame': '12 months', 'description': 'Patient and graft survival between inclusion and month 12.'}, {'measure': 'Economic evaluation of interventions measured by money spend in it.', 'timeFrame': '12 months', 'description': 'Comparison of economic evaluations of both interventions between inclusion and month 12.'}, {'measure': 'Estimated glomerular filtration rate.', 'timeFrame': '12 months', 'description': 'Change from baseline in glomerular filtration rate at 12 months.'}, {'measure': 'Change in blood calcium levels', 'timeFrame': '3 months', 'description': 'Change from baseline in blood calcium levels at 3 months.'}, {'measure': 'Change in blood calcium levels', 'timeFrame': '6 months', 'description': 'Change from baseline in blood calcium levels at 6 months.'}, {'measure': 'Change in parathyrin blood levels', 'timeFrame': '3 months', 'description': 'Change from baseline parathyrin blood levels at 3 months.'}, {'measure': 'Change in parathyrin blood levels', 'timeFrame': '6 months', 'description': 'Change from baseline parathyrin blood levels at 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Renal transplant', 'Hypercalcemia'], 'conditions': ['Secondary Hyperparathyroidism']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that subtotal parathyroidectomy using minimally invasive surgery is superior to cinacalcet for the treatment of persistent secondary hyperparathyroidism (HPT) post renal transplant, with minimal morbidity and significantly reduces the cost of treatment post transplant.', 'detailedDescription': 'Persistent hyperparathyroidism (HPT) with hypercalcemia is prevalent after transplant (affects up to 25% of patients) and negatively affects graft and patient outcome. The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet. Several studies guarantee that cinacalcet is effective in controlling hypercalcemia derived of persistent HPT after renal transplantation. However, maintenance treatment is need because hypercalcemia increases quickly after treatment is stopped. This fact makes increase a lot the cost of transplantation in these patients.\n\nThe hypothesis of this study is that subtotal parathyroidectomy by minimally invasive surgery is superior to cinacalcet for treatment of persistent secondary HPT post renal transplant, with minimal morbidity and significantly reduces the cost of treatment after transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Functioning renal transplant, GFR ≥ 30 ml / min\n* Time post-transplant\\> 6 months\n* PTHi\\>15pmol/L\n* Calcium ≥2.63 mmol/L con phosphatemia ≤1.2 mmol/L\n* Cervical scintigraphy\n* Signed informed consent\n\nExclusion Criteria:\n\n* Contraindication to surgery'}, 'identificationModule': {'nctId': 'NCT01178450', 'briefTitle': 'Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari de Bellvitge'}, 'officialTitle': 'A Prospective, Randomized Trial to Compare Subtotal Parathyroidectomy Versus Cinacalcet in the Treatment of Persistent Secondary Hyperparathyroidism Post Renal Transplantation', 'orgStudyIdInfo': {'id': '01PTHi'}, 'secondaryIdInfos': [{'id': '2008-007017-76', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Subtotal parathyroidectomy', 'description': 'The procedure of choice is subtotal parathyroidectomy if the intraoperative biopsy confirms multiglandular disease and at least 3 glands are removed leaving a remanent of one normal gland', 'interventionNames': ['Procedure: Subtotal parathyroidectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Cinacalcet', 'description': 'Cinacalcet is initiated at a dose of 30 mg per day PO, adjusting the dose monthly (up to 90 mg per day PO) to achieve normocalcemia', 'interventionNames': ['Drug: Cinacalcet']}], 'interventions': [{'name': 'Subtotal parathyroidectomy', 'type': 'PROCEDURE', 'otherNames': ['Parathyroidectomy'], 'description': 'The procedure of choice is subtotal parathyroidectomy if the intraoperative biopsy confirms multiglandular disease and at least 3 glands are removed leaving a remanent of one normal gland', 'armGroupLabels': ['Subtotal parathyroidectomy']}, {'name': 'Cinacalcet', 'type': 'DRUG', 'description': 'Cinacalcet is initiated at a dose of 30 mg per day PO, adjusting the dose monthly (up to 90 mg per day PO) to achieve normocalcemia', 'armGroupLabels': ['Cinacalcet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelone', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'overallOfficials': [{'name': 'Josep M Cruzado, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nephrology Department. Hospital Universitari de Bellvitge'}, {'name': 'Pablo Moreno, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Surgery Department. Hospital Universitari de Bellvitge'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Josep M Cruzado', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Nephrologist', 'investigatorFullName': 'Josep M Cruzado', 'investigatorAffiliation': 'Hospital Universitari de Bellvitge'}}}}