Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01447368
First received: October 4, 2011
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Kidney Failure
Secondary Hyperparathyroidism
Vascular Diseases
Drug: Cinacalcet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Change in coronary artery calcium score and heart valve calcium score [ Time Frame: wk 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cinacalcet treatment 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
Active Comparator: Surgical parathyroidectomy 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

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 and bone status have not been evaluatedand compared with parathyroidectomy.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447368

Contacts
Contact: Angela YM Wang, MD, PhD 22554949 aymwang@hku.hk

Locations
Hong Kong
Queen Mary Hospital and Tung Wah Hospital Recruiting
Hong Kong, Hong Kong, 0000
Contact: Angela YM Wang, MD, PhD    852-22554949    aymwang@hku.hk   
Principal Investigator: Angela YM Wang, MD, PhD         
Sub-Investigator: Wai-Kei Lo, FRCP         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Angela YM Wang, MD, PhD University of Hong Kong, Queen Mary Hospital
  More Information

No publications provided

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01447368     History of Changes
Other Study ID Numbers: CP-2015
Study First Received: October 4, 2011
Last Updated: June 19, 2013
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
chronic kidney disease
peritoneal dialysis
secondary hyperparathyroidism
parathyroidectomy
vascular calcification
cinacalcet

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Insufficiency
Vascular Diseases
Parathyroid Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014