Endstage Renal DiseaseNCT00745719
Parathyroidectomy in Endstage Renal Disease
A study testing parathyroidectomy in people with Endstage Renal Disease, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
To test the hypothesis that total parathyroidectomy retards cardiovascular calcification, improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in end-stage renal disease patients on maintenance dialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endstage Renal Disease
- What is being tested?
- parathyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteHong Kong
- Study dates
- Mar 2007to Jan 2012
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endstage renal disease patients receiving either long-term hemodialysis or peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 500pg/ml on two or more occasions.
- Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.
- Patients who provide informed consent for the study.
Who cannot join
- Patients with significant background valvular heart disease
- Patients who are unfit for general anaesthesia
- Patients with acute myocardial infarction within recent two months
- Patients with poor general condition
- Patients with plans for living related kidney transplant within 1 year
- Patients with previous history of parathyroidectomy
Show all 9Show fewer
- Patients with calciphylaxis
- Patients with underlying active malignancy
- Patients with contraindication for MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients
To test the hypothesis that total parathyroidectomy retards cardiovascular calcification, improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in end-stage renal disease patients on maintenance dialysis.
Read the detailed description
Secondary hyperparathyroidism (SHPT) in patients with end-stage renal disease contributes to increased cardiovascular morbidity and mortality via different mechanisms. Uncontrolled hyperparathyroidism is associated with left ventricular hypertrophy and has been implicated in the development of cardiac interstitial fibrosis and diastolic dysfunction.
- Conditions
- Endstage Renal Disease
- Being tested
- parathyroidectomy
- Keywords
- parathyroidectomy, cardiovascular, bone, endstage renal disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parathyroidectomyProcedure or surgery
Also called total parathyroidectomy with forearm autografting
total parathyroidectomy with forearm autografting
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | surgical total parathyroidectomy with forearm autografting Receives: Procedure: parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vascular and valvular calcium scores
Measured: 12 months
Secondary outcomes (12)
Change in bone mineral density
Measured: 12 months
change in aortic pulse wave velocity,
Measured: 12 months
change in left ventricular mass, volume and function
Measured: 12 months
changes in quality of life scores
Measured: 12 months
changes in iPTH
Measured: 6 and 12 months
changes in Serum calcium and phosphate
Measured: 6 and 12 months
changes in alkaline phosphatase
Measured: 6 and 12 months
changes in handgrip strength
Measured: 12 months
changes in subjective global assessment
Measured: 6 and 12 months
changes in serum albumin
Measured: 6 and 12 months
changes in inflammatory marker
Measured: 12 months
changes in HOMA index
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startMar 2007
- Primary completionSep 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endstage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Parathyroidectomy group versus natural disease control group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Angela Yee-Moon Wang, The University of Hong Kong
- Investigators
- Angela YM Wang, MD, PhD, Principal investigator, Queen Mary Hospital, University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745719
- Sponsor's protocol ID
- A111-102
- Status last verified
- Aug 2020
- First submitted
- 1 Sep 2008
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT00745719
- Acronym / sponsor ID
- A111-102
- Conditions
- Endstage Renal Disease
- Keywords
- parathyroidectomy, cardiovascular, bone, endstage renal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Sep 2008 (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.
To test the hypothesis that total parathyroidectomy retards cardiovascular calcification, improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in end-stage renal disease patients on maintenance dialysis.
Detailed description
Secondary hyperparathyroidism (SHPT) in patients with end-stage renal disease contributes to increased cardiovascular morbidity and mortality via different mechanisms. Uncontrolled hyperparathyroidism is associated with left ventricular hypertrophy and has been implicated in the development of cardiac interstitial fibrosis and diastolic dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Parathyroidectomy group versus natural disease control group
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: parathyroidectomysurgical total parathyroidectomy with forearm autografting |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Endstage renal disease patients receiving either long-term hemodialysis or peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 500pg/ml on two or more occasions.
- Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.
- Patients who provide informed consent for the study.
Key exclusion criteria (9 listed)
- Patients with significant background valvular heart disease
- Patients who are unfit for general anaesthesia
- Patients with acute myocardial infarction within recent two months
- Patients with poor general condition
- Patients with plans for living related kidney transplant within 1 year
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 |
|---|---|---|
| parathyroidectomyAlso: total parathyroidectomy with forearm autograftingtotal parathyroidectomy with forearm autografting | Procedure or surgery | 1 |
Primary outcome
Change in vascular and valvular calcium scores
Time frame: 12 months
12 secondary outcomes
Change in bone mineral density
Time frame: 12 months
change in aortic pulse wave velocity,
Time frame: 12 months
change in left ventricular mass, volume and function
Time frame: 12 months
changes in quality of life scores
Time frame: 12 months
changes in iPTH
Time frame: 6 and 12 months
changes in Serum calcium and phosphate
Time frame: 6 and 12 months
changes in alkaline phosphatase
Time frame: 6 and 12 months
changes in handgrip strength
Time frame: 12 months
changes in subjective global assessment
Time frame: 6 and 12 months
changes in serum albumin
Time frame: 6 and 12 months
changes in inflammatory marker
Time frame: 12 months
changes in HOMA index
Time frame: 6 and 12 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 5 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Endstage Renal Disease
Recruiting
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Endstage Renal Disease, Direct Oral Anticoagulants (DOACs)
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.
Angela YM Wang, MD, PhD principal investigator
Queen Mary Hospital, University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parathyroidectomy in people with Endstage Renal Disease, run by The University of Hong Kong at 1 site in Hong Kong.
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 9 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 5 Aug 2020. 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 Hong Kong. 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 vascular and valvular calcium scores (time frame: 12 months). 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 5 Aug 2020.