Clinical trial NCT01447368: Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure
Secondary Hyperparathyroidism
Vascular Diseases
Keywords: chronic kidney disease
peritoneal dialysis
secondary hyperparathyroidism
parathyroidectomy
vascular calcification
cinacalcet
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cinacalcet medical treatment versus total parathyroidectomy with forearm autografting surgical treatment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in coronary artery calcium score
timeFrame: 52 weeks
measure: change in left ventricular mass index
timeFrame: 52 weeks
Secondary outcomes:
measure: change in left ventricular volume and ejection fraction
timeFrame: 52 weeks
measure: Change in aortic pulse wave velocity
timeFrame: 24 and 52 weeks
measure: Change in aortic valve and mitral valve calcium score
timeFrame: 52 weeks
measure: change in augmentation index and heart rate adjusted augmentation index
timeFrame: over 52 weeks
measure: change in bone mineral density at forearm, spine and femur
timeFrame: 52 weeks
measure: Quality of Life (QOL) scores
timeFrame: 52 weeks
measure: change in resting energy expenditure
timeFrame: 24 and 52 weeks
measure: change in lean muscle mass
timeFrame: 52 weeks
measure: change in handgrip strength
timeFrame: 24 and 52 weeks
measure: Change in subjective global assessment
timeFrame: 24 and 52 weeks
measure: Change in serum calcium and phosphorus
timeFrame: over 52 weeks
measure: change in intact parathyroid hormone (iPTH) level
timeFrame: 52 weeks
measure: Change in alkaline phosphatase
timeFrame: over 52 weeks
measure: change in serum albumin
timeFrame: over 52 weeks
measure: change in lymphocyte count
timeFrame: over 52 weeks
measure: change in lipid profile
timeFrame: over 52 weeks
measure: change in systolic and diastolic blood pressure
timeFrame: over 52 weeks
measure: change in subendocardial viability ratio
timeFrame: over 52 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital and Tung Wah Hospital
Study officials:
affiliation: University of Hong Kong, Queen Mary Hospital
name: Angela YM Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: