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CompletedNCT03937349Updated Apr 17, 2024

Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

An observational study in Secondary Hyperparathyroidism, Chronic Kidney Disease Mineral and Bone Disorder and Vascular Calcification, sponsored by Saint Petersburg State University, Russia. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.

Primary conditionChronic Kidney Disease-Mineral and Bone DisorderRegistry: Hyperparathyroidism, SecondaryReclassifiedWhy we changed it
Registry
Hyperparathyroidism, Secondary — the first condition term the registry derived for this study.
ClinicalTrials.gg
Chronic Kidney Disease-Mineral and Bone Disorder
Why
  1. The study's listed conditions name Chronic Kidney Disease-Mineral and Bone Disorder, a narrower term within Hyperparathyroidism, Secondary.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Saint Petersburg State University, Russia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
63
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Secondary Hyperparathyroidism
  • Chronic Kidney Disease Mineral and Bone Disorder
  • Vascular Calcification
  • Dialysis
03

In context

Chronic Kidney Disease-Mineral and Bone Disorder Reclassified

73 studies on the registry are indexed under Chronic Kidney Disease-Mineral and Bone Disorder; 20 are open to participants now.

This study's enrollment of 63 is below the median of 164 across 36 observational studies indexed under Chronic Kidney Disease-Mineral and Bone Disorder.

Browse Chronic Kidney Disease-Mineral and Bone Disorder studies →

Lead sponsor

Saint Petersburg State University, Russia is the lead sponsor of 34 studies on the registry; 14 are open to participants now.

Compared within Chronic Kidney Disease-Mineral and Bone Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hyperparathyroidism, Secondary. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients receiving long-term dialysis treatment, met the criteria for parathyroidectomy due to severe SHPT

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age > 18 years
  2. ESRD patients receiving long-term hemodialysis or peritoneal dialysis treatment
  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

Exclusion criteria

Exclusion Criteria:

  1. Primary hyperparathyroidosis as a cause of ESRD
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Change in coronary artery calcium score measured with CT

    Time frame: 18 months

  2. Change in vascular calcification score measured with semi-quantitative (Kauppila) test

    Time frame: 18 months

Secondary outcomes

  1. Change in heart valve calcium score

    Time frame: 18 months

  2. Change in intact parathyroid hormone (iPTH) level

    Time frame: 18 months

  3. Change in serum calcium level

    Time frame: 18 months

  4. Change in serum phosphate level

    Time frame: 18weeks

  5. Change in alkaline phosphatase

    Time frame: 18 months

  6. Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period

    Time frame: 18 months

07

Study locations

1 site
  • Saint-Petersburg State University, Clinic of advanced medical technologies n.a. N.I.Pirogov
    Saint Petersburg, 190103, Russian Federation
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2019 to primary completion in Jan 2024, 56 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2019
First posted
May 3, 2019
StartActual
May 14, 2019
Primary completionActual
Jan 18, 2024
CompletionActual
Jan 18, 2024
Last update
Apr 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03937349
Lead sponsor
Saint Petersburg State University, Russia
Responsible party
Ekaterina Parshina (Principal investigator, Saint Petersburg State University, Russia) — Principal investigator
First posted
May 3, 2019
Start date
May 14, 2019
Primary completion
Jan 18, 2024
Completion
Jan 18, 2024
Last update
Apr 17, 2024

Study contacts

Ekaterina Parshina, MD
principal investigator · Saint Petersburg State University, Russia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Saint Petersburg State University, Russia

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