Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).
NCT ID: NCT04750460
Last Updated: 2022-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2021-03-01
2022-02-16
Brief Summary
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Detailed Description
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This is a feasible study aimed to determine the sample size for further large-scale trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Teriparatide
Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.
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).
No interventions assigned to this group
Interventions
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Teriparatide
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with end-stage renal disease (ESRD) receiving hemodialysis or peritoneal dialysis treatment \> 3 months prior surgery;
3. 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;
4. Performed total parathyroidectomy with autotransplantation of the parathyroid tissue.
Exclusion Criteria
2. Primary hyperparathyroidism as a cause of ESRD;
3. Scheduled (before surgery) blood transfusion;
4. Re-operative surgery;
5. Known allergy to the study drug.
6. Malignant neoplasms of bone tissue (primary or metastatic).
18 Years
ALL
No
Sponsors
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Saint Petersburg State University, Russia
OTHER
Responsible Party
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Novokshonov Konstantin
MD, PHD
Locations
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Saint-Petersburg State University Hospital
Saint Petersburg, , Russia
Countries
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Other Identifiers
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TeriCa
Identifier Type: -
Identifier Source: org_study_id
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