Secondary HyperparathyroidismNCT03937349
Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients
An observational study of 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 prospective cohort study aimed to evaluate change of cardiovascular calcification after parathyroidectomy in patients with end-stage renal disease on dialysis compared with control group on conservative treatment. 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, Vascular Calcification
- How many people
- 63 participants
- Where
- 1 siteRussia
- Study dates
- 14 May 2019to 18 Jan 2024
- Phase
- Observational
- 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
Study population: Patients receiving long-term dialysis treatment, met the criteria for parathyroidectomy due to severe SHPT
Who may be able to join
- Age > 18 years
- ESRD patients receiving long-term hemodialysis or peritoneal dialysis treatment
- 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
Who cannot join
- 1. Primary hyperparathyroidosis as a cause of ESRD
Trial locations and contacts
1 site in 1 country.
Russia1 site
Saint-Petersburg State University, Clinic of advanced medical technologies n.a. N.I.Pirogov
Saint Petersburg, 190103
About this study
Official title: Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients: a Prospective Cohort Study
This is a prospective cohort study aimed to evaluate change of cardiovascular calcification after parathyroidectomy in patients with end-stage renal disease on dialysis compared with control group on conservative treatment.
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease Mineral and Bone Disorder, Vascular Calcification, Dialysis
- Medical subject headings
- Hyperparathyroidism, Secondary, Chronic Kidney Disease-Mineral and Bone Disorder, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sPTx group | Patients underwent subtotal parathyroidectomy due to severe secondary hyperparathyroidism | |
| TPTx+AT group | Patients underwent total parathyroidectomy with immediate autotransplantation of parathyroid tissue due to severe secondary hyperparathyroidism | |
| Control group | Patients with severe SHPT on conservative treatment (calcimimetics, active vitamin D analogues, phosphate-binders) who are likely to undergo surgery in a period of 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in coronary artery calcium score measured with CT
Measured: 18 months
Change in vascular calcification score measured with semi-quantitative (Kauppila) test
Measured: 18 months
Secondary outcomes (6)
Change in heart valve calcium score
Measured: 18 months
Change in intact parathyroid hormone (iPTH) level
Measured: 18 months
Change in serum calcium level
Measured: 18 months
Change in serum phosphate level
Measured: 18weeks
Change in alkaline phosphatase
Measured: 18 months
Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start14 May 2019
- Primary completion18 Jan 2024
- Study completion18 Jan 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekaterina Parshina, Saint Petersburg State University, Russia
- Investigators
- Ekaterina Parshina, MD, Principal investigator, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937349
- Sponsor's protocol ID
- Calcification
- Status last verified
- Apr 2024
- First submitted
- 1 May 2019
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03937349
- Acronym / sponsor ID
- Calcification
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease Mineral and Bone Disorder, Vascular Calcification, Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 3 May 2019 (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 prospective cohort study aimed to evaluate change of cardiovascular calcification after parathyroidectomy in patients with end-stage renal disease on dialysis compared with control group on conservative treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sPTx group | – | –Patients underwent subtotal parathyroidectomy due to severe secondary hyperparathyroidism |
| TPTx+AT group | – | –Patients underwent total parathyroidectomy with immediate autotransplantation of parathyroid tissue due to severe secondary hyperparathyroidism |
| Control group | – | –Patients with severe SHPT on conservative treatment (calcimimetics, active vitamin D analogues, phosphate-binders) who are likely to undergo surgery in a period of 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving long-term dialysis treatment, met the criteria for parathyroidectomy due to severe SHPT
Key inclusion criteria (3 listed)
- Age > 18 years
- ESRD patients receiving long-term hemodialysis or peritoneal dialysis treatment
- 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
Key exclusion criteria (1 listed)
- 1. Primary hyperparathyroidosis as a cause of ESRD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in coronary artery calcium score measured with CT
Time frame: 18 months
Change in vascular calcification score measured with semi-quantitative (Kauppila) test
Time frame: 18 months
6 secondary outcomes
Change in heart valve calcium score
Time frame: 18 months
Change in intact parathyroid hormone (iPTH) level
Time frame: 18 months
Change in serum calcium level
Time frame: 18 months
Change in serum phosphate level
Time frame: 18weeks
Change in alkaline phosphatase
Time frame: 18 months
Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period
Time frame: 18 months
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 17 Apr 2024.
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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.
Ekaterina Parshina, MD principal investigator
Saint Petersburg State University, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 1 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 17 Apr 2024. 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.
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?
Change in coronary artery calcium score measured with CT (time frame: 18 months). The study lists 2 primary outcomes in all. 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 17 Apr 2024.