Parathyroidectomy in Endstage Renal Disease

August 2, 2020 updated by: Dr. Angela Yee-Moon Wang, The University of Hong Kong

A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 0000
        • Queen Mary Hospital, Tung Wah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
surgical total parathyroidectomy with forearm autografting
Procedure: parathyroidectomy
total parathyroidectomy with forearm autografting
Other Names:
  • total parathyroidectomy with forearm autografting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in vascular and valvular calcium scores
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in bone mineral density
Time Frame: 12 months
12 months
change in aortic pulse wave velocity,
Time Frame: 12 months
12 months
change in left ventricular mass, volume and function
Time Frame: 12 months
12 months
changes in quality of life scores
Time Frame: 12 months
12 months
changes in iPTH
Time Frame: 6 and 12 months
6 and 12 months
changes in Serum calcium and phosphate
Time Frame: 6 and 12 months
6 and 12 months
changes in alkaline phosphatase
Time Frame: 6 and 12 months
6 and 12 months
changes in handgrip strength
Time Frame: 12 months
12 months
changes in subjective global assessment
Time Frame: 6 and 12 months
6 and 12 months
changes in serum albumin
Time Frame: 6 and 12 months
6 and 12 months
changes in inflammatory marker
Time Frame: 12 months
12 months
changes in HOMA index
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Angela YM Wang, MD, PhD, Queen Mary Hospital, University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

September 1, 2008

First Submitted That Met QC Criteria

September 1, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Actual)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 2, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A111-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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