Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

The University of Hong Kong67 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Kidney Failure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in coronary artery calcium score

Time frame: 52 weeks

change in left ventricular mass index

Time frame: 52 weeks

Secondary Outcomes

change in left ventricular volume and ejection fraction

Time frame: 52 weeks

Change in aortic pulse wave velocity

Time frame: 24 and 52 weeks

Change in aortic valve and mitral valve calcium score

Time frame: 52 weeks

change in augmentation index and heart rate adjusted augmentation index

Time frame: over 52 weeks

change in bone mineral density at forearm, spine and femur

Time frame: 52 weeks

Quality of Life (QOL) scores

Kidney Disease Outcome Quality Initiatives (KDOQI QOL domain scores)

Time frame: 52 weeks

change in resting energy expenditure

Change in resting energy expenditure

Time frame: 24 and 52 weeks

change in lean muscle mass

Change in lean muscle mass

Time frame: 52 weeks

change in handgrip strength

Change in handgrip strength

Time frame: 24 and 52 weeks

Change in subjective global assessment

Time frame: 24 and 52 weeks

Change in serum calcium and phosphorus

Change in biochemical parameter Serum calcium and phosphorus

Time frame: over 52 weeks

change in intact parathyroid hormone (iPTH) level

Change in biochemical parameter Parathyroid hormone

Time frame: 52 weeks

Change in alkaline phosphatase

Change in biochemical parameter alkaline phosphatase

Time frame: over 52 weeks

change in serum albumin

CHange in biochemical parameter serum albumin

Time frame: over 52 weeks

change in lymphocyte count

Time frame: over 52 weeks

change in lipid profile

Time frame: over 52 weeks

change in systolic and diastolic blood pressure

Time frame: over 52 weeks

change in subendocardial viability ratio

Time frame: over 52 weeks

Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes