Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

Phase 4

Completed

• Conditions: Kidney Failure; Secondary Hyperparathyroidism; Vascular Diseases
• Interventions: Procedure: Surgical total parathyroidectomy with forearm autografting; Drug: Cinacalcet

• Registration Number: NCT01447368
• Lead Sponsor: The University of Hong Kong

Brief 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.

Study Timeline

• Study Start: 2010-05-10
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-06
• Primary Completion: 2017-05-22
• Study Completion: 2017-05-22
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

1. ESRD patients on long-term peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels > 800pg/mL.
2. Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
3. Patients with age between 18 - 75 years.

Exclusion Criteria

1. Patients with background valvular heart disease
2. Patients who are unfit for general anaesthesia
3. Patients with acute myocardial infarction within recent two months
4. Patients with poor general condition
5. Patients with plans for living related kidney transplant within 1 year
6. Patients with previous history of parathyroidectomy
7. Patients with underlying malignancy
8. Patients with hepatic dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical total parathyroidectomy	Surgical total parathyroidectomy with forearm autografting	Surgical total parathyroidectomy with forearm autografting will be performed for patients randomized to this arm.
Cinacalcet treatment	Cinacalcet	Oral Cinacalcet treatment arm, 25mg daily to be administered and gradually step up as required to control iPTH between 2 - 9 times lab reference range, Maximum dose to be given is 100mg daily

Primary Outcome Measures

Name	Time	Method
Change in coronary artery calcium score	52 weeks	Change in coronary artery calcium score
change in left ventricular mass index	52 weeks	change in left ventricular mass index

Secondary Outcome Measures

Name	Time	Method
change in left ventricular volume and ejection fraction	52 weeks	change in left ventricular volume and ejection fraction
Change in aortic pulse wave velocity	24 and 52 weeks	Change in aortic pulse wave velocity
Change in aortic valve and mitral valve calcium score	52 weeks	Change in aortic valve and mitral valve calcium score
change in augmentation index and heart rate adjusted augmentation index	over 52 weeks	change in augmentation index and heart rate adjusted augmentation index
change in bone mineral density at forearm, spine and femur	52 weeks	change in bone mineral density at forearm, spine and femur
Quality of Life (QOL) scores	52 weeks	Kidney Disease Outcome Quality Initiatives (KDOQI QOL domain scores)
change in resting energy expenditure	24 and 52 weeks	Change in resting energy expenditure
change in lean muscle mass	52 weeks	Change in lean muscle mass
change in handgrip strength	24 and 52 weeks	Change in handgrip strength
Change in subjective global assessment	24 and 52 weeks	Change in subjective global assessment
Change in serum calcium and phosphorus	over 52 weeks	Change in biochemical parameter Serum calcium and phosphorus
change in intact parathyroid hormone (iPTH) level	52 weeks	Change in biochemical parameter Parathyroid hormone
Change in alkaline phosphatase	over 52 weeks	Change in biochemical parameter alkaline phosphatase
change in serum albumin	over 52 weeks	CHange in biochemical parameter serum albumin
change in lymphocyte count	over 52 weeks	change in lymphocyte count
change in lipid profile	over 52 weeks	change in lipid profile
change in systolic and diastolic blood pressure	over 52 weeks	change in systolic and diastolic blood pressure
change in subendocardial viability ratio	over 52 weeks	change in subendocardial viability ratio

Trial Locations

Locations (1)

Queen Mary Hospital and Tung Wah Hospital; 🇭🇰 Hong Kong, Hong Kong