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

Phase 3

Completed

• Conditions: Hypocalcemia; Chronic Kidney Disease-Mineral and Bone Disorder; Hypoparathyroidism; Dialysis; Secondary Hyperparathyroidism
• Interventions: Drug: Teriparatide

• Registration Number: NCT04750460
• Lead Sponsor: Saint Petersburg State University, Russia

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-dependent patients.

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 Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-11
• Study Start: 2021-03-01
• Primary Completion: 2022-02-16
• Study Completion: 2022-02-16
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teriparatide group (11 patients)	Teriparatide	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.

Primary Outcome Measures

Name	Time	Method
Total serum calcium level	Day 1,2,3,4,5

Secondary Outcome Measures

Name	Time	Method
Serum total alkaline phosphatase level	Day 1, 2, 3, 4, 5
Ionized serum calcium level	Day 1, 2, 3, 4, 5
Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)	up to 1 week
Parathyroid hormone level	Day 1, 2, 3, 4, 5
Serum phosphorus level	Day 1, 2, 3, 4, 5
Total serum calcium level	Day 2, 3, 4, 5

Trial Locations

Locations (1)

Saint-Petersburg State University Hospital; 🇷🇺 Saint Petersburg, Russian Federation