NCT01140490

Brief Summary

The aim of this study was to evaluate whether successful sub-total parathyroidectomy retards cardiovascular calcification in patients with hemodialysis and to investigate the mechanism .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 11, 2011

Status Verified

January 1, 2009

Enrollment Period

2 years

First QC Date

June 7, 2010

Last Update Submit

March 10, 2011

Conditions

Hemodialysis

Keywords

HemodialysisSub-total Parathyroidectomy

Outcome Measures

Primary Outcomes (1)

  • Change in vascular calcium scores

    12 months

Secondary Outcomes (1)

  • Change in left ventricular systolic and diastolic function

    12 months

Study Arms (1)

Sub-total Parathyroidectomy

NO INTERVENTION
Procedure: Sub-total Parathyroidectomy

Interventions

Sub-total ParathyroidectomyPROCEDURE

Sub-total Parathyroidectomy

Sub-total Parathyroidectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients receiving hemodialysis treatment, with elevated intact parathyroid hormone (iPTH) levels \> 800pg/ml on two or more occasions.
  • Patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Study Officials

  • Shi wei, MD PHD

    Chinese Nephrology Committee

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shi Wei, MD and PHD

CONTACT

8602083827812shiw_ggh@126.com

Liu shuangxin, MD and PHD

CONTACT

8602083827812mplsxi@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 9, 2010

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

December 1, 2011

Last Updated

March 11, 2011

Record last verified: 2009-01

Locations

CN(1)