Working… Menu

Parathyroidectomy in Endstage Renal Disease

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. Identifier: NCT00745719
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : August 5, 2020
Information provided by (Responsible Party):
Dr. Angela Yee-Moon Wang, The University of Hong Kong

Brief Summary:
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 or disease Intervention/treatment Phase
Endstage Renal Disease Procedure: parathyroidectomy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Parathyroidectomy group versus natural disease control group
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
Study Start Date : March 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
surgical total parathyroidectomy with forearm autografting
Procedure: parathyroidectomy
total parathyroidectomy with forearm autografting
Other Name: total parathyroidectomy with forearm autografting

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

Secondary Outcome Measures :
  1. Change in bone mineral density [ Time Frame: 12 months ]
  2. change in aortic pulse wave velocity, [ Time Frame: 12 months ]
  3. change in left ventricular mass, volume and function [ Time Frame: 12 months ]
  4. changes in quality of life scores [ Time Frame: 12 months ]
  5. changes in iPTH [ Time Frame: 6 and 12 months ]
  6. changes in Serum calcium and phosphate [ Time Frame: 6 and 12 months ]
  7. changes in alkaline phosphatase [ Time Frame: 6 and 12 months ]
  8. changes in handgrip strength [ Time Frame: 12 months ]
  9. changes in subjective global assessment [ Time Frame: 6 and 12 months ]
  10. changes in serum albumin [ Time Frame: 6 and 12 months ]
  11. changes in inflammatory marker [ Time Frame: 12 months ]
  12. changes in HOMA index [ Time Frame: 6 and 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT00745719

Layout table for location information
Hong Kong
Queen Mary Hospital, Tung Wah Hospital
Hong Kong, Hong Kong, 0000
Sponsors and Collaborators
The University of Hong Kong
Layout table for investigator information
Principal Investigator: Angela YM Wang, MD, PhD Queen Mary Hospital, University of Hong Kong
Layout table for additonal information
Responsible Party: Dr. Angela Yee-Moon Wang, Honorary Associate Professor, The University of Hong Kong Identifier: NCT00745719    
Other Study ID Numbers: A111-102
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Angela Yee-Moon Wang, The University of Hong Kong:
endstage renal disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency