Status:
COMPLETED
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients
Lead Sponsor:
The University of Hong Kong
Conditions:
Kidney Failure
Secondary Hyperparathyroidism
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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,...
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 vascu...
Eligibility Criteria
Inclusion
- ESRD patients on long-term peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels \> 800pg/mL.
- Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
- Patients with age between 18 - 75 years.
Exclusion
- Patients with background valvular heart disease
- Patients who are unfit for general anaesthesia
- Patients with acute myocardial infarction within recent two months
- Patients with poor general condition
- Patients with plans for living related kidney transplant within 1 year
- Patients with previous history of parathyroidectomy
- Patients with underlying malignancy
- Patients with hepatic dysfunction
Key Trial Info
Start Date :
May 10 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2017
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01447368
Start Date
May 10 2010
End Date
May 22 2017
Last Update
October 12 2021
Active Locations (1)
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1
Queen Mary Hospital and Tung Wah Hospital
Hong Kong, Hong Kong, 0000