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Parathyroidectomy in Endstage Renal Disease

Primary Purpose

Endstage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
parathyroidectomy
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endstage Renal Disease focused on measuring parathyroidectomy, cardiovascular, bone, endstage renal disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Mary Hospital, Tung Wah Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

surgical total parathyroidectomy with forearm autografting

Outcomes

Primary Outcome Measures

Change in vascular and valvular calcium scores

Secondary Outcome Measures

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

Full Information

First Posted
September 1, 2008
Last Updated
August 2, 2020
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00745719
Brief Title
Parathyroidectomy in Endstage Renal Disease
Official Title
A Pilot Study to Evaluate the Efficacy of Total Parathyroidectomy in Retarding Cardiovascular Calcification in End-stage Renal Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endstage Renal Disease
Keywords
parathyroidectomy, cardiovascular, bone, endstage renal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Parathyroidectomy group versus natural disease control group
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
surgical total parathyroidectomy with forearm autografting
Intervention Type
Procedure
Intervention Name(s)
parathyroidectomy
Other Intervention Name(s)
total parathyroidectomy with forearm autografting
Intervention Description
total parathyroidectomy with forearm autografting
Primary Outcome Measure Information:
Title
Change in vascular and valvular calcium scores
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in bone mineral density
Time Frame
12 months
Title
change in aortic pulse wave velocity,
Time Frame
12 months
Title
change in left ventricular mass, volume and function
Time Frame
12 months
Title
changes in quality of life scores
Time Frame
12 months
Title
changes in iPTH
Time Frame
6 and 12 months
Title
changes in Serum calcium and phosphate
Time Frame
6 and 12 months
Title
changes in alkaline phosphatase
Time Frame
6 and 12 months
Title
changes in handgrip strength
Time Frame
12 months
Title
changes in subjective global assessment
Time Frame
6 and 12 months
Title
changes in serum albumin
Time Frame
6 and 12 months
Title
changes in inflammatory marker
Time Frame
12 months
Title
changes in HOMA index
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela YM Wang, MD, PhD
Organizational Affiliation
Queen Mary Hospital, University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital, Tung Wah Hospital
City
Hong Kong
ZIP/Postal Code
0000
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Parathyroidectomy in Endstage Renal Disease

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