Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients
NCT01447368 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2021-10-12
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
- Kidney Failure
- Secondary Hyperparathyroidism
- Vascular Diseases
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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