HyperparathyroidismNCT00452049
The Effect of Parathyroidectomy on Renal Function, Endothelial Function, and Blood Pressure
An observational study of Hyperparathyroidism and Hypertension, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Secondary hyperparathyroidism (HPT) is a known complication of chronic renal failure. Elevated concentrations of parathyroid hormone (PTH) play a role not only in the pathogenesis of renal bone disease, but also in the development of cardiovascular risk factors such as disturbed lipid metabolism, glucose intolerance… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hyperparathyroidism, Hypertension
- What is being tested?
- parathyroidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2005to not given
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Renal transplant recipients
Who may be able to join
- Stable renal transplant recipients/CKD stage 5D patients.
- Age between 18 years and 85 years.
- Signed informed consent.
- PTX scheduled because of severe hyperparathyroidism (day 0)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hopsital Leuven
Leuven, 3000
Pieter Evenepoel, MD, PhD, 003216344580, pieter.evenepoel@uz.kuleuven.ac.be
About this study
Official title: Observational Study to Evaluate the Effect of Parathyroidectomy on Renal Function, Endothelial Function and Blood Pressure
Secondary hyperparathyroidism (HPT) is a known complication of chronic renal failure. Elevated concentrations of parathyroid hormone (PTH) play a role not only in the pathogenesis of renal bone disease, but also in the development of cardiovascular risk factors such as disturbed lipid metabolism, glucose intolerance, and hypertension. HPT is also known to play an important role in the development of structural abnormalities of both large arteries and the heart (left ventricular hypertrophy, interstitial fibrosis). In the last couple of years there has been increasing evidence from animal studies that the endothelium is a target organ of PTH.
Hypothesis: PTH has clinically relevant effects on renal hemodynamics, renal function and endothelial function.
Read more
Aims:
- To evaluate the effect of parathyroidectomy (PTX) on renal hemodynamics in stable renal transplant recipients
- To evaluate the effect of PTX on endothelial function in stable renal transplant recipients/chronic kidney disease (CKD) stage 5 patients
- To evaluate the effect of PTX on blood pressure in stable renal transplant recipients/CKD stage 5 patients
- Conditions
- Hyperparathyroidism, Hypertension
- Being tested
- parathyroidectomy
- Keywords
- parathyroidectomy, arterial stiffness, renal function
- Medical subject headings
- Hyperparathyroidism, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parathyroidectomyProcedure or surgery
parathyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2007 (estimated)
- Study startApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evenepoel Pieter, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Pieter Evenepoel, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452049
- Sponsor's protocol ID
- ML3052
- Status last verified
- May 2012
- First submitted
- 23 Mar 2007
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Evenepoel P, Claes K, Viaene L, Bammens B, Meijers B, Naesens M, Sprangers B, Kuypers D. Decreased Circulating Sclerostin Levels in Renal Transplant Recipients With Persistent Hyperparathyroidism. Transplantation. 2016 Oct;100(10):2188-93. doi: 10.1097/TP.0000000000001311.
PubMed 27379556
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate the Effect of Parathyroidectomy on Renal Function, Endothelial Function and Blood Pressure
- ClinicalTrials.gov ID
- NCT00452049
- Acronym / sponsor ID
- ML3052
- Conditions
- Hyperparathyroidism, Hypertension
- Keywords
- parathyroidectomy, arterial stiffness, renal function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Apr 2005
- First posted
- 26 Mar 2007 (estimated)
- 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.
Secondary hyperparathyroidism (HPT) is a known complication of chronic renal failure. Elevated concentrations of parathyroid hormone (PTH) play a role not only in the pathogenesis of renal bone disease, but also in the development of cardiovascular risk factors such as disturbed lipid metabolism, glucose intolerance, and hypertension. HPT is also known to play an important role in the development of structural abnormalities of both large arteries and the heart (left ventricular hypertrophy, interstitial fibrosis). In the last couple of years there has been increasing evidence from animal studies that the endothelium is a target organ of PTH.
Hypothesis: PTH has clinically relevant effects on renal hemodynamics, renal function and endothelial function.
Aims:
- To evaluate the effect of parathyroidectomy (PTX) on renal hemodynamics in stable renal transplant recipients
- To evaluate the effect of PTX on endothelial function in stable renal transplant recipients/chronic kidney disease (CKD) stage 5 patients
- To evaluate the effect of PTX on blood pressure in stable renal transplant recipients/CKD stage 5 patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal transplant recipients
Key inclusion criteria (4 listed)
- Stable renal transplant recipients/CKD stage 5D patients.
- Age between 18 years and 85 years.
- Signed informed consent.
- PTX scheduled because of severe hyperparathyroidism (day 0)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| parathyroidectomyparathyroidectomy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
- Derived from this study: PubMed 27379556Evenepoel P, Claes K, Viaene L, Bammens B, Meijers B, Naesens M, Sprangers B, Kuypers D. Decreased Circulating Sclerostin Levels in Renal Transplant Recipients With Persistent Hyperparathyroidism. Transplantation. 2016 Oct;100(10):2188-93. doi: 10.1097/TP.0000000000001311.
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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.
Pieter Evenepoel, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Hyperparathyroidism and Hypertension, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 0 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: status not confirmed, as of the sponsor's last update on 30 May 2012. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pieter Evenepoel, MD, PhD (003216344580, pieter.evenepoel@uz.kuleuven.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00452049, which also lists 1 linked publication.
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 30 May 2012.