This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Parathyroidectomy in Endstage Renal Disease

This study has been completed.
Information provided by (Responsible Party):
Dr. Angela Yee-Moon Wang, The University of Hong Kong Identifier:
First received: September 1, 2008
Last updated: January 14, 2017
Last verified: January 2017
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.

Condition Intervention Phase
Endstage Renal Disease Procedure: parathyroidectomy Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients

Resource links provided by NLM:

Further study details as provided by Dr. Angela Yee-Moon Wang, The University of Hong Kong:

Primary Outcome Measures:
  • Change in vascular and valvular calcium scores [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 62
Study Start Date: March 2007
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
surgical total parathyroidectomy with forearm autografting
Procedure: parathyroidectomy
total parathyroidectomy with forearm autografting
Other Name: total parathyroidectomy with forearm autografting

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Patients with calciphylaxis
  • Patients with underlying active malignancy
  • Patients with contraindication for MRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00745719

Hong Kong
Queen Mary Hospital, Tung Wah Hospital
Hong Kong, Hong Kong, 0000
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: Angela YM Wang, MD, PhD Queen Mary Hospital, University of Hong Kong
  More Information

Responsible Party: Dr. Angela Yee-Moon Wang, Honorary Associate Professor, The University of Hong Kong Identifier: NCT00745719     History of Changes
Other Study ID Numbers: A111-102
Study First Received: September 1, 2008
Last Updated: January 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Angela Yee-Moon Wang, The University of Hong Kong:
endstage renal disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency processed this record on September 19, 2017