Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

NCT01447368 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2021-10-12

No results posted yet for this study

Summary

This is a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of severe SHPT, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification and left ventricular mass index in endstage renal disease patients receiving peritoneal dialysis over 12 months. The change in arterial stiffening, left ventricular volume, aortic valve calcium score and bone mineral density, nutritional status and biochemical parameters, quality of life measures will be evaluated as secondary objectives of this study.

Conditions

Interventions

DRUG

Cinacalcet

oral cinacalcet 25mg once daily as a start and up titrated by 25mg daily according to response in lowering PTH and maximum oral dose allowed is 100mg daily

PROCEDURE

Surgical total parathyroidectomy with forearm autografting

Surgical total parathyroidectomy with forearm autografting will be performed

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Angela YM Wang, MD, PhD · University of Hong Kong, Queen Mary Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-10
Primary Completion
2017-05-22
Completion
2017-05-22

Countries

  • Hong Kong

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01447368 on ClinicalTrials.gov