Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).

• Status: Enrolling by invitation
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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-dependent patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saint Petersburg State University, Russia
• Treatments: Teriparatide

Criteria

Inclusion Criteria:

1. Age > 18 years;

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:

1. Emergency surgery;

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).