Status:
COMPLETED
Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).
Lead Sponsor:
Saint Petersburg State University, Russia
Conditions:
Secondary Hyperparathyroidism
Chronic Kidney Disease-Mineral and Bone Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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-de...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04750460
Start Date
March 1 2021
End Date
February 16 2022
Last Update
November 10 2022
Active Locations (1)
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1
Saint-Petersburg State University Hospital
Saint Petersburg, Russia, 190103