Secondary HyperparathyroidismPhase 3TeriCaNCT04750460
Injection of Teriparatide to Prevent Hypocalcemia After Parathyroidectomy in Dialysis Patients (TeriCa).
A Phase 3 study testing Teriparatide in people with Secondary Hyperparathyroidism and Chronic Kidney Disease-Mineral and Bone Disorder, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, Chronic Kidney Disease-Mineral and Bone Disorder, Dialysis
- What is being tested?
- Teriparatide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2021to 16 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Russia1 site
Saint-Petersburg State University Hospital
Saint Petersburg, 190103
About this study
Official title: The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized Trial
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.
Read the 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.
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease-Mineral and Bone Disorder, Dialysis, Hypocalcemia, Hypoparathyroidism
- Being tested
- Teriparatide
- Keywords
- Parathyroidectomy, Teriparatide, Parathyroid hormone
- Medical subject headings
- Hyperparathyroidism, Secondary, Chronic Kidney Disease-Mineral and Bone Disorder, Hypocalcemia, Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called Forsteo
Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide group (11 patients) | Experimental | 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. Receives: Drug: Teriparatide |
| Control group (9 patients) | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total serum calcium level
Measured: Day 1,2,3,4,5
Secondary outcomes (6)
Parathyroid hormone level
Measured: Day 1, 2, 3, 4, 5
Serum phosphorus level
Measured: Day 1, 2, 3, 4, 5
Serum total alkaline phosphatase level
Measured: Day 1, 2, 3, 4, 5
Total serum calcium level
Measured: Day 2, 3, 4, 5
Ionized serum calcium level
Measured: Day 1, 2, 3, 4, 5
Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Mar 2021
- Primary completion16 Feb 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Novokshonov Konstantin, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750460
- Sponsor's protocol ID
- TeriCa
- Acronym
- TeriCa
- Status last verified
- Nov 2022
- First submitted
- 2 Feb 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Teriparatide on the Early Postoperative Hypocalcemia After Parathyroidectomy in Dialysis Patients: a Pilot, Randomized Trial
- ClinicalTrials.gov ID
- NCT04750460
- Acronym / sponsor ID
- TeriCa / TeriCa
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease-Mineral and Bone Disorder, Dialysis, Hypocalcemia, Hypoparathyroidism
- Keywords
- Parathyroidectomy, Teriparatide, Parathyroid hormone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teriparatide group (11 patients) | Experimental | Drug: TeriparatideDialysis-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. |
| Control group (9 patients) | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Emergency surgery;
- Primary hyperparathyroidism as a cause of ESRD;
- Scheduled (before surgery) blood transfusion;
- Re-operative surgery;
- Known allergy to the study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeriparatideAlso: ForsteoSubcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day. | Drug | Teriparatide group (11 patients) |
Primary outcome
Total serum calcium level
Time frame: Day 1,2,3,4,5
6 secondary outcomes
Parathyroid hormone level
Time frame: Day 1, 2, 3, 4, 5
Serum phosphorus level
Time frame: Day 1, 2, 3, 4, 5
Serum total alkaline phosphatase level
Time frame: Day 1, 2, 3, 4, 5
Total serum calcium level
Time frame: Day 2, 3, 4, 5
Ionized serum calcium level
Time frame: Day 1, 2, 3, 4, 5
Serious adverse events (major cardiovascular events, fractures, arrhythmia episodes, death)
Time frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teriparatide in people with Secondary Hyperparathyroidism and Chronic Kidney Disease-Mineral and Bone Disorder, run by Saint Petersburg State University, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total serum calcium level (time frame: Day 1,2,3,4,5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.