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Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Dr. Angela Yee-Moon Wang, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01447368
First received: October 4, 2011
Last updated: January 7, 2017
Last verified: January 2017

October 4, 2011
January 7, 2017
May 2010
December 2017   (final data collection date for primary outcome measure)
Change in coronary artery calcium score and heart valve calcium score [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
Change in coronary artery calcium score and heart valve calcium score [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01447368 on ClinicalTrials.gov Archive Site
  • Change in aortic pulse wave velocity [ Time Frame: over 24 and 52 weeks ] [ Designated as safety issue: No ]
  • change in bone mineral density at forearm, spine and femur [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
  • change in left ventricular mass index [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
  • change in left ventricular volume and function [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
  • Quality of Life scores [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
  • change in lean muscle mass [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
  • change in handgrip strength [ Time Frame: over 24 and 52 weeks ] [ Designated as safety issue: No ]
  • Change in subjective global assessment and serum albumin [ Time Frame: over 24 and 52 weeks ] [ Designated as safety issue: No ]
  • change in resting energy expenditure [ Time Frame: over 24 and 52 weeks ] [ Designated as safety issue: No ]
  • change in intact parathyroid hormone (iPTH) level, calcium, phosphate, ALP [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
  • Change in parathyroid gland size [ Time Frame: over 52 weeks ] [ Designated as safety issue: No ]
  • Change in aortic pulse wave velocity [ Time Frame: week 24 and wk 52 ] [ Designated as safety issue: No ]
  • change in parathyroid gland size (cinacalcet treatment arm only) [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
  • change in left ventricular mass index [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
  • change in left ventricular volume and function [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
  • change in bone mineral density at forearm, spine and femur [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
  • change in insulin resistance index [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
  • Change in subjective global assessment [ Time Frame: wk 24 and 52 ] [ Designated as safety issue: No ]
  • change in lean muscle mass [ Time Frame: wk 52 ] [ Designated as safety issue: No ]
  • change in resting energy expenditure [ Time Frame: wk 24 and wk 52 ] [ Designated as safety issue: No ]
  • change in intact parathyroid hormone (iPTH) level [ Time Frame: Wk 12, 24, 36 and 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients
Comparison of Medical (Oral Cinacalcet) Therapy Versus Surgical Therapy (Total Parathyroidectomy) on Vascular/Valvular Calcification in Chronic Peritoneal Dialysis Patients With Secondary Hyperparathyroidism - A Pilot Study
We propose a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of SHPT, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification in endstage renal disease patients over 12 months. The change in arterial stiffening and bone mineral density as well as nutritional status 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 and bone status have not been evaluatedand compared with parathyroidectomy.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Kidney Failure
  • Secondary Hyperparathyroidism
  • Vascular Diseases
  • 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
    Other Name: Regpara
  • Procedure: Surgical total parathyroidectomy with forearm autografting
    Surgical total parathyroidectomy with forearm autografting will be performed
  • Experimental: Cinacalcet treatment
    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
    Intervention: Drug: Cinacalcet
  • Active Comparator: Surgical total parathyroidectomy
    Surgical total parathyroidectomy with forearm autografting will be performed for patients randomized to this arm.
    Intervention: Procedure: Surgical total parathyroidectomy with forearm autografting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
December 2017
December 2017   (final data collection date for primary outcome measure)

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
All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Angela YM Wang, MD, PhD 22554949 aymwang@hku.hk
Hong Kong
 
NCT01447368
CP-2015
No
No
Not Provided
Dr. Angela Yee-Moon Wang, The University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: Angela YM Wang, MD, PhD University of Hong Kong, Queen Mary Hospital
The University of Hong Kong
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP