Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

Vascular Diseases Clinical Trial

— PROCEED  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447368
• Other study ID #: CP-2015
• Status: Completed
• Phase: Phase 4
• Start date: May 10, 2010
• Est. completion date: May 22, 2017

Study information

• Verified date: October 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 22, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Failure
• Neoplasm Metastasis
• Renal Insufficiency
• Secondary Hyperparathyroidism
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital and Tung Wah Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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