HyperparathyroidismNCT01640184
Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients
A study testing Parathyroidectomy, Active vitamin D and Ultrasonic ablation in people with Hyperparathyroidism and Disorders of Parathyroid Gland, run by Dongliang Zhang, MD at 2 sites in China.
Trial summary
It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney disease (CKD) patients who had not succeeded medical therapy and could not get parathyroidectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperparathyroidism, Disorders of Parathyroid Gland
- What is being tested?
- Parathyroidectomy, Active vitamin D and Ultrasonic ablation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2012to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age between 18 - 75 years.
- Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
- CKD patients in stage 5, with elevated intact parathyroid hormone (iPTH) levels > 800pg/mL.
- CKD patients have been followed up more than 6 months.
Who cannot join
- Primary or Tertiary Hyperparathyroidism (hyperparathyroidism after kidney transplantation).
- Patient who underwent total parathyroidectomy and without enlarged parathyroid gland(s).
- Known history of parathyroid or other neoplasias in the neck region.
- History of neck irradiation.
- Major surgery of neck in the last 3 months or other major surgery projected in the subsequent 4 months.
- Pregnant or lactating woman.
Show all 12Show fewer
- Patient receiving drugs such as phenobarbital, phenytoin, rifampicin, sucralfate, steroids, flecainide, thioridazine, or most tricyclic antidepressants which could affect vitamin D metabolism.
- Treatment with vitamin D derivatives, cinacalcet or other calcimimetics within the past 6 months.
- Patients who are currently participating in another clinical trial.
- The expected live time is less than 1 year.
- Patients suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
- Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100020
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
About this study
Official title: Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.
It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney disease (CKD) patients who had not succeeded medical therapy and could not get parathyroidectomy. The investigators suppose that ultrasonic ablation may be a valuable alternative treatment that help control secondary hyperparathyroidism in CKD patients presenting with enlarged parathyroid gland(s) visible at ultrasonography.
Read the detailed description
Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term dialysis treatments. sHPT is damaged for bone system, blood system, cardiovascular system, and so on. The treatment of the sHPT of CKD's patient includes dietary phosphate restriction, the use of medicines, and parathyroidectomy. In the mainland of China, there are not certain useful medicines to treat sHPT, including the derivatives of vitamin D, calcimimetic agent, non calcium aluminum phosphate binders. Furthermore, medical therapy is not always successful in achieving adequate control of sHPT. Oral medications have efficacy limitations as well as side-effects. Otherwise, surgery treatment can only be used for the patients with enlarged parathyroid gland(s). The patients may suffer from the injury of operation, hypoparathyroidism, or recurrence of hyperparathyroidism after parathyroidectomy.
Then ultrasonic ablation may become a valuable alternative treatment that help control sHPT in selected patients presenting with enlarged parathyroid gland(s) visible at ultrasonography,.
- Being tested
- Parathyroidectomy, Active vitamin D, Ultrasonic ablation
- Keywords
- hyperparathyroidism, vitamin D, ultrasonic ablation, surgery
- Medical subject headings
- Hyperparathyroidism, Parathyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParathyroidectomyProcedure or surgery
Also called Parathyroid surgery
sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Active vitamin DDrug
Also called Oral medicine
CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.
Ultrasonic ablationProcedure or surgery
Also called Ultrasonic intervention
CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Active vitamin D | Active comparator | Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in Kidney Developement Improvement Global Outcomes (KDIGO) guidelines. Receives: Drug: Active vitamin D |
| Ultrasonic ablation | Experimental | Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Receives: Procedure: Ultrasonic ablation |
| Parathyroidectomy | Active comparator | Patients in parathyroidectomy group will be treated by parathyroid surgery. Receives: Procedure: Parathyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.
The blood levels of intact parathyroid hormone (iPTH) will be detected every 3 months for stable patients. The blood test will be more frequent, at least once per-month, after the ultrasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.
Measured: 12 months
Secondary outcomes (5)
Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).
Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.
Measured: 12 months
Changes of the Blood Levels on Calcium During 12 Months.
The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.
Measured: Baseline and 12 months
Changes of Blood Levels on Phosphorus During 12 Months.
The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.
Measured: Baseline and 12 months
Changes of Blood Levels on iPTH During 12 Months.
The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.
Measured: Baseline and 12 months
Changes of Blood Levels on Bone Specific Alkaline Phosphatase.
The blood levels of bone specific alkaline phosphatase will be detected at least once every 3 months and will be compared to the baseline levels.
Measured: Baseline 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 posted13 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongliang Zhang, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Sponsor-investigator, Dongliang Zhang, MD, Capital Medical University
- Investigators
- Linxue Qian, Doctor, Principal investigator, Beijing Friendship HospitalDongliang Zhang, Doctor, Study director, Beijing Friendship HospitalWenhu Liu, Doctor, Study chair, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640184
- Sponsor's protocol ID
- 2012-079
- Other IDs
- Z121107001012138, 2001-2002-02
- Status last verified
- Aug 2016
- First submitted
- 9 Jul 2012
- Last updated
- 17 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.
- ClinicalTrials.gov ID
- NCT01640184
- Acronym / sponsor ID
- 2012-079
- Keywords
- hyperparathyroidism, vitamin D, ultrasonic ablation, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Dongliang Zhang, MDUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Aug 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Posted 20 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney disease (CKD) patients who had not succeeded medical therapy and could not get parathyroidectomy. The investigators suppose that ultrasonic ablation may be a valuable alternative treatment that help control secondary hyperparathyroidism in CKD patients presenting with enlarged parathyroid gland(s) visible at ultrasonography.
Detailed description
Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term dialysis treatments. sHPT is damaged for bone system, blood system, cardiovascular system, and so on. The treatment of the sHPT of CKD's patient includes dietary phosphate restriction, the use of medicines, and parathyroidectomy. In the mainland of China, there are not certain useful medicines to treat sHPT, including the derivatives of vitamin D, calcimimetic agent, non calcium aluminum phosphate binders. Furthermore, medical therapy is not always successful in achieving adequate control of sHPT. Oral medications have efficacy limitations as well as side-effects. Otherwise, surgery treatment can only be used for the patients with enlarged parathyroid gland(s). The patients may suffer from the injury of operation, hypoparathyroidism, or recurrence of hyperparathyroidism after parathyroidectomy.
Then ultrasonic ablation may become a valuable alternative treatment that help control sHPT in selected patients presenting with enlarged parathyroid gland(s) visible at ultrasonography,.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active vitamin D | Active comparator | Drug: Active vitamin DPatients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in Kidney Developement Improvement Global Outcomes (KDIGO) guidelines. |
| Ultrasonic ablation | Experimental | Procedure: Ultrasonic ablationPatients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. |
| Parathyroidectomy | Active comparator | Procedure: ParathyroidectomyPatients in parathyroidectomy group will be treated by parathyroid surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with age between 18 - 75 years.
- Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
- CKD patients in stage 5, with elevated intact parathyroid hormone (iPTH) levels > 800pg/mL.
- CKD patients have been followed up more than 6 months.
Key exclusion criteria (12 listed)
- Primary or Tertiary Hyperparathyroidism (hyperparathyroidism after kidney transplantation).
- Patient who underwent total parathyroidectomy and without enlarged parathyroid gland(s).
- Known history of parathyroid or other neoplasias in the neck region.
- History of neck irradiation.
- Major surgery of neck in the last 3 months or other major surgery projected in the subsequent 4 months.
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: Parathyroid surgerysHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery. | Procedure or surgery | Parathyroidectomy |
| Active vitamin DAlso: Oral medicineCKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines. | Drug | Active vitamin D |
| Ultrasonic ablationAlso: Ultrasonic interventionCKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively. | Procedure or surgery | Ultrasonic ablation |
Primary outcome
Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.
Time frame: 12 months
The blood levels of intact parathyroid hormone (iPTH) will be detected every 3 months for stable patients. The blood test will be more frequent, at least once per-month, after the ultrasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.
5 secondary outcomes
Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).
Time frame: 12 months
Changes of the Blood Levels on Calcium During 12 Months.
Time frame: Baseline and 12 months
Changes of Blood Levels on Phosphorus During 12 Months.
Time frame: Baseline and 12 months
Changes of Blood Levels on iPTH During 12 Months.
Time frame: Baseline and 12 months
Changes of Blood Levels on Bone Specific Alkaline Phosphatase.
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Linxue Qian, Doctor principal investigator
Beijing Friendship Hospital
Dongliang Zhang, Doctor study director
Beijing Friendship Hospital
Wenhu Liu, Doctor study chair
Beijing Friendship Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parathyroidectomy, Active vitamin D and Ultrasonic ablation in people with Hyperparathyroidism and Disorders of Parathyroid Gland, run by Dongliang Zhang, MD at 2 sites in China.
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 12 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 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines. (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 17 Oct 2016.