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

Primary Purpose

Secondary Hyperparathyroidism, Chronic Kidney Disease-Mineral and Bone Disorder, Dialysis

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Teriparatide
Sponsored by
Saint Petersburg State University, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Parathyroidectomy, Teriparatide, Parathyroid hormone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Saint-Petersburg State University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Teriparatide group (11 patients)

Control group (9 patients)

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Total serum calcium level

Secondary Outcome Measures

Parathyroid hormone level
Serum phosphorus level
Serum total alkaline phosphatase level
Total serum calcium level
Ionized serum calcium level
Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)

Full Information

First Posted
February 2, 2021
Last Updated
November 7, 2022
Sponsor
Saint Petersburg State University, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT04750460
Brief Title
Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).
Acronym
TeriCa
Official Title
The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
February 16, 2022 (Actual)
Study Completion Date
February 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Petersburg State University, Russia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism, Chronic Kidney Disease-Mineral and Bone Disorder, Dialysis, Hypocalcemia, Hypoparathyroidism
Keywords
Parathyroidectomy, Teriparatide, Parathyroid hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teriparatide group (11 patients)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (9 patients)
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
Forsteo
Intervention Description
Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.
Primary Outcome Measure Information:
Title
Total serum calcium level
Time Frame
Day 1,2,3,4,5
Secondary Outcome Measure Information:
Title
Parathyroid hormone level
Time Frame
Day 1, 2, 3, 4, 5
Title
Serum phosphorus level
Time Frame
Day 1, 2, 3, 4, 5
Title
Serum total alkaline phosphatase level
Time Frame
Day 1, 2, 3, 4, 5
Title
Total serum calcium level
Time Frame
Day 2, 3, 4, 5
Title
Ionized serum calcium level
Time Frame
Day 1, 2, 3, 4, 5
Title
Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)
Time Frame
up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Saint-Petersburg State University Hospital
City
Saint Petersburg
ZIP/Postal Code
190103
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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