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Parathyroidectomy in Endstage Renal Disease

This study has been completed.
Information provided by (Responsible Party):
The University of Hong Kong Identifier:
First received: September 1, 2008
Last updated: June 19, 2013
Last verified: June 2013
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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 The University of Hong Kong:

Primary Outcome Measures:
  • Change in vascular and valvular calcium scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in bone mineral density, left ventricular mass and volume, left ventricular systolic and diastolic function, augmentation index and pulse wave velocity, inflammatory marker, HOMA, quality of life score, handgrip, Parathyroid hormone level [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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
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)
Genders Eligible for Study:   Both
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
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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: The University of Hong Kong Identifier: NCT00745719     History of Changes
Other Study ID Numbers: A111-102 
Study First Received: September 1, 2008
Last Updated: June 19, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by 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 December 02, 2016