NCT01447368

Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

Comparison of Medical Therapy (Oral Cinacalcet) Versus Surgical Therapy (Total Parathyroidectomy) on Vascular/Valvular Calcification in Chronic Peritoneal Dialysis Patients With Secondary Hyperparathyroidism - A Pilot Randomized Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with severe secondary hyperparathyroidism (SHPT) are frequently complicated with vascular calcification. There is some suggestion that subtotal parathyroidectomy may reduce or stabilize vascular calcium scores in dialysis patients. Experimental data suggests that SHPT plays an important role in mediating uraemic arterial disease and that parathyroidectomy largely prevented the development of calcification. Cinacalcet has emerged as a novel therapy for the treatment of SHPT and has been shown to reduce the need for surgical parathyroidectomy. However, their effects on vascular, cardiac, bone and nutrition status have not been evaluated and compared with parathyroidectomy.

Conditions

• Kidney Failure
• Secondary Hyperparathyroidism
• Vascular Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-05-10
• Primary completion: 2017-05-22
• Completion: 2017-05-22
• First posted: 2011-10-06
• Last updated: 2021-10-12

Locations

1 site across 1 country: Hong Kong