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Trial record 3 of 6 for:    "Hyperthyroidism" | "Calcium"

Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients

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ClinicalTrials.gov Identifier: NCT01640184
Recruitment Status : Completed
First Posted : July 13, 2012
Results First Posted : November 20, 2015
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Dongliang Zhang, MD, Capital Medical University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism Disorders of Parathyroid Gland Procedure: Parathyroidectomy Drug: Active vitamin D Procedure: Ultrasonic ablation Not Applicable

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,.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.
Study Start Date : August 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Active vitamin D
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.
Drug: Active vitamin D
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.
Other Name: Oral medicine

Experimental: Ultrasonic ablation
Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
Procedure: Ultrasonic ablation
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.
Other Name: Ultrasonic intervention

Active Comparator: Parathyroidectomy
Patients in parathyroidectomy group will be treated by parathyroid surgery.
Procedure: Parathyroidectomy
sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Other Name: Parathyroid surgery




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of Injury on the Recurrent Laryngeal Nerve (RLN). [ Time Frame: 12 months ]
    Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.

  2. Changes of the Blood Levels on Calcium During 12 Months. [ Time Frame: Baseline and 12 months ]
    The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.

  3. Changes of Blood Levels on Phosphorus During 12 Months. [ Time Frame: Baseline and 12 months ]
    The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.

  4. Changes of Blood Levels on iPTH During 12 Months. [ Time Frame: Baseline and 12 months ]
    The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.

  5. Changes of Blood Levels on Bone Specific Alkaline Phosphatase. [ Time Frame: Baseline and 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640184


Locations
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China, Beijing
Beijing Chao-Yang Hospital
Beijing, Beijing, China, 100020
Beijing Friendship Hospital
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Dongliang Zhang, MD
Beijing Municipal Science & Technology Commission
Investigators
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Principal Investigator: Linxue Qian, Doctor Beijing Friendship Hospital
Study Director: Dongliang Zhang, Doctor Beijing Friendship Hospital
Study Chair: Wenhu Liu, Doctor Beijing Friendship Hospital

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Responsible Party: Dongliang Zhang, MD, associate professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT01640184    
Other Study ID Numbers: 2012-079
Z121107001012138 ( Other Grant/Funding Number: Beijing Municipal Science and Technology Commission )
2001-2002-02 ( Other Grant/Funding Number: The capital health research and development of special )
First Posted: July 13, 2012    Key Record Dates
Results First Posted: November 20, 2015
Last Update Posted: October 17, 2016
Last Verified: August 2016
Keywords provided by Dongliang Zhang, MD, Capital Medical University:
hyperparathyroidism
vitamin D
ultrasonic ablation
surgery
Additional relevant MeSH terms:
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Calcium-Regulating Hormones and Agents
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Parathyroid Diseases
Urologic Diseases
Renal Insufficiency
Endocrine System Diseases
Vitamin D
Ergocalciferols
Vitamins
Parathyroid Hormone
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents