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Secondary HyperparathyroidismNCT02332135

The Efficacy and Safety of Microwave Ablation for Mild-to-moderate Secondary Hyperparathyroidism Patients Undergoing Hemodialysis

A study testing microwave ablation and active vitamin D in people with Secondary Hyperparathyroidism and Maintenance Hemodialysis, run by Wenhu Liu at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Microwave ablation, as a new method to therapy secondary hyperparathyroidism(SHPT), now is developing rapidly. However, it is still unknown whether it is effective to accept microwave ablation for hemodialysis patients with mild-to-moderate SHPT. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
microwave ablation and active vitamin D
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Jan 2015to Mar 2018
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 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.
  • patients in hemodialysis, whose iPTH is between 300pg/ml and 800pg/ml.

Who cannot join

  • primary or tertiary hyperparathyroidism(hyperparathyroidism after kidney transplantation).
  • patient who underwent total parathyroidectomy.
  • Known history of parathyroid or other neoplasias in the neck region.
  • History of neck trauma.
  • major surgery of neck in the last 3 months or in next 4months.
  • pregnant or lactating woman.
Show all 11Show fewer
  • patients with severe liver disease and abnormal blood clotting mechanism.
  • patients with chronic wasting disease.
  • patients who is taking glucocorticoids.
  • patients who have other disorders affecting calcium and phosphorus metabolism.
  • patients whose concurrent illnesses,disability,or geographical residence would hamper attendance at required study visit.

Trial locations and contacts

1 site in 1 country.

Zongli Diao, master contact

+86-01-63138579

diaoted@163.com

China1 site, 1 recruiting
  • Beijing Friedship Hospital

    Beijing, Beijing Municipality, 100050

    Wenhu Liu, Doctor, +86-01-63139144, liuwh0211@126.com

    Zongli Diao, Master

    Recruiting

Other trials in China

About this study

Microwave ablation, as a new method to therapy secondary hyperparathyroidism(SHPT), now is developing rapidly. However, it is still unknown whether it is effective to accept microwave ablation for hemodialysis patients with mild-to-moderate SHPT. In this prospective, randomised control and paried clinical trial study, the investigators will observe the efficiency and safety of microwave ablation in hemodialysis patients with mild-to-moderate secondary hyperparathyroidism. The patients in age-matched control group will accept active Vitamin D therapy.

Read the detailed description

Secondary hyperparathyroidism(SHPT) is common in hemodialysis(HD) patients. SHPT can damage cardiovascular system , bone system, and so forth. The treatment of SHPT of HD patients includes dietary phosphate restriction, the use of medicines, parathyroidectomy, and microwave ablation, which is a new method booming over the past decade. However, In the mainland of China, medical therapy is not always successful in achieving adequate control of SHPT. Oral medications have limitations as well as side effects. The patients may suffer from the injury of operation, hypoparathyroidism, or recurrence of hyperparathyroidism after parathyroidectomy. Moreover, the fear of operation for patients also limits its development. Thus, microwave ablation may become a valuable alternative treatment to help control SHPT in selected patients presenting with enlarged parathyroid gland(s) visible at ultrasonography. Nevertheless, nowadays there isn't a guideline for doctors to choose when to use microwave ablation to therapy SHPT. Furthermore, different experts have different views. Experts in Japan consider that, for SHPT , the earlier one takes microwave ablation, the better he may be, while others think, Just as parathyroidectomy, microwave ablation is merely used for the patient whose intact parathyroid hormone (iPTH) is more than 800pg/ml, or who has serious symptom. From their perspective, this is no proof that accepting microwave ablation for SHPT in early stage becomes better. However, as we all know, as the disease progresses, the therapy becomes increasingly difficult. Since microwave ablation is minimally invasive, safe,the investigators consider, patients who have parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan would get more benefit if they undergo microwave ablation the instant that SHPT is diagnosed. So, In this prospective, randomised control and paried clinical trial study, the investigators will observe the efficiency and safety of microwave ablation in hemodialysis patients with secondary hyperparathyroidism in early stage. First, the investigators detect the iPTH levels of all the patients in the investigators' blood purification center. The patients whose iPTH are between 300pg/ml and 800pg/ml and who have parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan are chosen to involve in this study. The patients with age-matched and iPTH between 300pg/ml and 800pg/ml were enrolled in this study. In the control group, patients will accept vitamin D to treat SHPT, according to the suggestions in K/DOQI guidelines. Meanwhile, in the microwave ablation group, patients will accept microwave ablation. Then, all of the patients will be followed for 24 months to compare the rate of achieving the target on iPTH level according to K/DOQI guidelines, the change of iPTH level after MWA,the rate of subjects developed into severe SHPT, as well as calcium and phosphorus level, Quality of Life and mortality in each group.

Being tested
microwave ablation, active vitamin D
Keywords
microwave ablation, maintenance hemodialysis, mild-to-moderate Secondary Hyperparathyroidism
Medical subject headings
Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • microwave ablationProcedure or surgery

    First, the investigators detect the iPTH levels of all the patients in the investigators' blood purification center. The patients whose iPTH are between 300pg/ml and 800pg/ml and who have parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan are chosen to involve in this study. Patients are divided into 2 groups at random, the control group and the microwave ablation group. In the microwave ablation group, patients will accept microwave ablation. Oral medicines, if needed, will be taken according to the the suggestions in K/DOQI guideline.

  • active vitamin DDrug

    The control group will be treated by active vitamin D and other general treatment,such as dietary phosphate restriction and phosphate binders,according to the suggestions in K/DOQI guideline.

Study groups in NCT02332135
Study groupRoleWhat they receive
microwave ablation groupExperimentalpatients in ultrasonic ablation will be treated by ultrasound guided percutaneous parathyroid gland microwave ablation
Receives: Procedure: microwave ablation
control groupActive comparatorpatients in control group will be treated by active vitamin D and other general treatments according to the suggestions in K/DOQI guidelines
Receives: Drug: active vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall rate of achieving target for iPTH during the study period.

    The blood level of intact iPTH will be detected every other month for stable patients.

    Measured: 12 months

  2. The change of iPTH level after MWA.

    The blood level of intact iPTH will be detected every other month for stable

    Measured: 12 months

  3. The rate of subjects developed into severe SHPT

    Measured: 12 months

Secondary outcomes (3)
  1. Calcitriol weekly dosage.

    calcification score in every 6 months

    Measured: 12 months

  2. Overall rate of achieving target for serum calcium and phosphorus.

    Measured: 12 months

  3. Changes of serum calcium and phosphorus after MWA.

    The blood level of bone specific alkaline phosphatase will be detected every other months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionMar 2017 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02332135
Sponsor's protocol ID
BJFH-EC/2014-101
Status last verified
May 2016
First submitted
4 Jan 2015
Last updated
24 May 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing microwave ablation and active vitamin D in people with Secondary Hyperparathyroidism and Maintenance Hemodialysis, run by Wenhu Liu at 1 site 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 3 inclusion and 11 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 24 May 2016. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zongli Diao, master (+86-01-63138579, diaoted@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall rate of achieving target for iPTH during the study period. (time frame: 12 months). The study lists 3 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 24 May 2016.

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