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Parathyroidectomy in Endstage Renal Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00745719
First Posted: September 3, 2008
Last Update Posted: January 18, 2017
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.
Information provided by (Responsible Party):
Dr. Angela Yee-Moon Wang, The University of Hong Kong
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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

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
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): NCT00745719


Locations
Hong Kong
Queen Mary Hospital, Tung Wah Hospital
Hong Kong, Hong Kong, 0000
Sponsors and Collaborators
The University of Hong Kong
Investigators
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
ClinicalTrials.gov Identifier: NCT00745719     History of Changes
Other Study ID Numbers: A111-102
First Submitted: September 1, 2008
First Posted: September 3, 2008
Last Update Posted: January 18, 2017
Last Verified: January 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:
parathyroidectomy
cardiovascular
bone
endstage renal disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency