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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 9, 2012
First Posted Date  ICMJE July 13, 2012
Results First Submitted Date  ICMJE October 21, 2015
Results First Posted Date  ICMJE November 20, 2015
Last Update Posted Date October 17, 2016
Study Start Date  ICMJE August 2012
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2012)
Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to 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 ultasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2012)
  • Detection of the vascular and valve calcification. [ Time Frame: 12 months ]
    Chest radiography will be done to calculate the aortic arch calcification score (AoACS) at both baseline and the 12th month. Echocardiogram will aslo be proceeded to detect the valve calcification at two time point.
  • Change in subjective global assessment (SGA). [ Time Frame: Month 0, 6, and 12 ]
    Comparation of the SGA scores among month 6 and month 12 to baseline.
  • Incidence of Injury on the Recurrent Laryngeal Nerve (RLN). [ Time Frame: 12 months ]
    Comparation of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.
  • Changes of the Blood Levels on Calcium During 12 Months. [ Time Frame: 12 months ]
    The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.
  • Changes of Blood Levels on Phosphorus During 12 Months. [ Time Frame: 12 months ]
    The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.
  • Changes of Blood Levels on iPTH During 12 Months. [ Time Frame: 12 months ]
    The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.
  • Changes of Blood Levels on Bone Specific Alkaline Phosphatase. [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients
Official Title  ICMJE Study of the Efficacy and Safety on the Ultrasonic Ablation Treatment for Secondary Hyperthyroidism in Chronic Kidney Disease Patients.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperparathyroidism
  • Disorders of Parathyroid Gland
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Active vitamin D
  • Experimental: Ultrasonic ablation
    Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.
    Intervention: Procedure: Ultrasonic ablation
  • Active Comparator: Parathyroidectomy
    Patients in parathyroidectomy group will be treated by parathyroid surgery.
    Intervention: Procedure: Parathyroidectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2016)
79
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2012)
80
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01640184
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dongliang Zhang, MD, Capital Medical University
Study Sponsor  ICMJE Dongliang Zhang, MD
Collaborators  ICMJE Beijing Municipal Science & Technology Commission
Investigators  ICMJE
Principal Investigator: Linxue Qian, Doctor Beijing Friendship Hospital
Study Director: Dongliang Zhang, Doctor Beijing Friendship Hospital
Study Chair: Wenhu Liu, Doctor Beijing Friendship Hospital
PRS Account Capital Medical University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP