- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04750460
Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa). (TeriCa)
The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
This is a feasible study aimed to determine the sample size for further large-scale trial.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Saint Petersburg, Russian Federation, 190103
- Saint-Petersburg State University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 18 years;
- Patients with end-stage renal disease (ESRD) receiving hemodialysis or peritoneal dialysis treatment > 3 months prior surgery;
- 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;
- Performed total parathyroidectomy with autotransplantation of the parathyroid tissue.
Exclusion Criteria:
- Emergency surgery;
- Primary hyperparathyroidism as a cause of ESRD;
- Scheduled (before surgery) blood transfusion;
- Re-operative surgery;
- Known allergy to the study drug.
- Malignant neoplasms of bone tissue (primary or metastatic).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Teriparatide group (11 patients)
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.
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Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.
Other Names:
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NO_INTERVENTION: Control group (9 patients)
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total serum calcium level
Time Frame: Day 1,2,3,4,5
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Day 1,2,3,4,5
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Parathyroid hormone level
Time Frame: Day 1, 2, 3, 4, 5
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Day 1, 2, 3, 4, 5
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Serum phosphorus level
Time Frame: Day 1, 2, 3, 4, 5
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Day 1, 2, 3, 4, 5
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Serum total alkaline phosphatase level
Time Frame: Day 1, 2, 3, 4, 5
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Day 1, 2, 3, 4, 5
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Total serum calcium level
Time Frame: Day 2, 3, 4, 5
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Day 2, 3, 4, 5
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Ionized serum calcium level
Time Frame: Day 1, 2, 3, 4, 5
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Day 1, 2, 3, 4, 5
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Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)
Time Frame: up to 1 week
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up to 1 week
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Urologic Diseases
- Endocrine System Diseases
- Renal Insufficiency
- Nutrition Disorders
- Musculoskeletal Diseases
- Parathyroid Diseases
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Bone Diseases, Metabolic
- Calcium Metabolism Disorders
- Water-Electrolyte Imbalance
- Rickets
- Vitamin D Deficiency
- Kidney Diseases
- Renal Insufficiency, Chronic
- Hyperparathyroidism
- Bone Diseases
- Hyperparathyroidism, Secondary
- Hypoparathyroidism
- Chronic Kidney Disease-Mineral and Bone Disorder
- Hypocalcemia
- Physiological Effects of Drugs
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Teriparatide
Other Study ID Numbers
- TeriCa
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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