Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT04750460
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2021-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D012080', 'term': 'Chronic Kidney Disease-Mineral and Bone Disorder'}, {'id': 'D006996', 'term': 'Hypocalcemia'}, {'id': 'D007011', 'term': 'Hypoparathyroidism'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019379', 'term': 'Teriparatide'}], 'ancestors': [{'id': 'D010281', 'term': 'Parathyroid Hormone'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total serum calcium level', 'timeFrame': 'Day 1,2,3,4,5'}], 'secondaryOutcomes': [{'measure': 'Parathyroid hormone level', 'timeFrame': 'Day 1, 2, 3, 4, 5'}, {'measure': 'Serum phosphorus level', 'timeFrame': 'Day 1, 2, 3, 4, 5'}, {'measure': 'Serum total alkaline phosphatase level', 'timeFrame': 'Day 1, 2, 3, 4, 5'}, {'measure': 'Total serum calcium level', 'timeFrame': 'Day 2, 3, 4, 5'}, {'measure': 'Ionized serum calcium level', 'timeFrame': 'Day 1, 2, 3, 4, 5'}, {'measure': 'Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)', 'timeFrame': 'up to 1 week'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parathyroidectomy', 'Teriparatide', 'Parathyroid hormone'], 'conditions': ['Secondary Hyperparathyroidism', 'Chronic Kidney Disease-Mineral and Bone Disorder', 'Dialysis', 'Hypocalcemia', 'Hypoparathyroidism']}, 'descriptionModule': {'briefSummary': 'This is a pilot randomized controlled trial aimed to evaluate the effect of teriparatide on the clinical course of hypocalcemia after parathyroidectomy for secondary hyperparathyroidism in dialysis-dependent patients.', 'detailedDescription': 'Postoperative hypocalcemia is a common complication after parathyroidectomy (PTx) for secondary hyperparathyroidism in dialysis-dependent patients. It is known to be associated with significant drop of parathyroid hormone (iPTH) level after surgery. Thus, in the present study we test the hypothesis that reducing iPTH difference before/after PTx with teriparatide injections immediately after surgery may alleviate clinical course of post-PTx hypocalcemia.\n\nThis is a feasible study aimed to determine the sample size for further large-scale trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years;\n2. Patients with end-stage renal disease (ESRD) receiving hemodialysis or peritoneal dialysis treatment \\> 3 months prior surgery;\n3. Severe secondary hyperparathyroidism defined as iPTH level \\> 800 pg/ml, followed with hypercalcemia and/or hyperphosphatemia; with presence of one or more nodular or diffuse parathyroid hyperplasia confirmed with CT;\n4. Performed total parathyroidectomy with autotransplantation of the parathyroid tissue.\n\nExclusion Criteria:\n\n1. Emergency surgery;\n2. Primary hyperparathyroidism as a cause of ESRD;\n3. Scheduled (before surgery) blood transfusion;\n4. Re-operative surgery;\n5. Known allergy to the study drug.\n6. Malignant neoplasms of bone tissue (primary or metastatic).'}, 'identificationModule': {'nctId': 'NCT04750460', 'acronym': 'TeriCa', 'briefTitle': 'Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).', 'organization': {'class': 'OTHER', 'fullName': 'Saint Petersburg State University, Russia'}, 'officialTitle': 'The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized Trial', 'orgStudyIdInfo': {'id': 'TeriCa'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teriparatide group (11 patients)', 'description': 'Dialysis-dependent patients underwent total parathyroidectomy with autotransplantation of parathyroid tissue, who will receive subcutaneous injections ot recombinant parathyroid hormone (Teriparatide) after surgery in addition to the standard local protocol for hypocalcemia treatment.', 'interventionNames': ['Drug: Teriparatide']}, {'type': 'NO_INTERVENTION', 'label': 'Control group (9 patients)', 'description': 'Dialysis-dependent patients underwent total parathyroidectomy with autotransplantation of parathyroid tissue, receiving standard local protocol for hypocalcemia treatment (2 micrograms of alphacalcidol plus 4 grams of oral calcium daily).'}], 'interventions': [{'name': 'Teriparatide', 'type': 'DRUG', 'otherNames': ['Forsteo'], 'description': 'Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.', 'armGroupLabels': ['Teriparatide group (11 patients)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '190103', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Saint-Petersburg State University Hospital', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Petersburg State University, Russia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PHD', 'investigatorFullName': 'Novokshonov Konstantin', 'investigatorAffiliation': 'Saint Petersburg State University, Russia'}}}}