Cinacalcet Versus Parathyroidectomy in Peritoneal Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01447368
Recruitment Status : Recruiting
First Posted : October 6, 2011
Last Update Posted : January 18, 2017
Information provided by (Responsible Party):
Dr. Angela Yee-Moon Wang, The University of Hong Kong

Brief Summary:
This is 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 or disease Intervention/treatment Phase
Kidney Failure Secondary Hyperparathyroidism Vascular Diseases Drug: Cinacalcet Procedure: Surgical total parathyroidectomy with forearm autografting Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : May 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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 total parathyroidectomy
Surgical total parathyroidectomy with forearm autografting will be performed for patients randomized to this arm.
Procedure: Surgical total parathyroidectomy with forearm autografting
Surgical total parathyroidectomy with forearm autografting will be performed

Primary Outcome Measures :
  1. Change in coronary artery calcium score and heart valve calcium score [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Change in aortic pulse wave velocity [ Time Frame: 24 and 52 weeks ]
  2. change in bone mineral density at forearm, spine and femur [ Time Frame: 52 weeks ]
  3. change in left ventricular mass index [ Time Frame: 52 weeks ]
  4. change in left ventricular volume and function [ Time Frame: 52 weeks ]
  5. Quality of Life scores [ Time Frame: 52 weeks ]
  6. change in lean muscle mass [ Time Frame: 52 weeks ]
  7. change in handgrip strength [ Time Frame: 24 and 52 weeks ]
  8. Change in subjective global assessment [ Time Frame: 24 and 52 weeks ]
  9. change in resting energy expenditure [ Time Frame: 24 and 52 weeks ]
  10. change in intact parathyroid hormone (iPTH) level [ Time Frame: 52 weeks ]
  11. Change in parathyroid gland size [ Time Frame: 52 weeks ]
  12. change in serum albumin [ Time Frame: 24 and 52 weeks ]
  13. Change in serum calcium and phosphate [ Time Frame: 24 and 52 weeks ]
  14. Change in alkaline phosphatase [ Time Frame: 24 and 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01447368

Contact: Angela YM Wang, MD, PhD 22554949

Hong Kong
Queen Mary Hospital and Tung Wah Hospital Recruiting
Hong Kong, Hong Kong, 0000
Contact: Angela YM Wang, MD, PhD    852-22554949   
Principal Investigator: Angela YM Wang, MD, PhD         
Sub-Investigator: Wai-Kei Lo, FRCP         
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: Angela YM Wang, MD, PhD University of Hong Kong, Queen Mary Hospital

Responsible Party: Dr. Angela Yee-Moon Wang, Honorary Associate Professor, The University of Hong Kong Identifier: NCT01447368     History of Changes
Other Study ID Numbers: CP-2015
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Angela Yee-Moon Wang, The University of Hong Kong:
chronic kidney disease
peritoneal dialysis
secondary hyperparathyroidism
vascular calcification

Additional relevant MeSH terms:
Neoplasm Metastasis
Vascular Diseases
Renal Insufficiency
Hyperparathyroidism, Secondary
Neoplastic Processes
Pathologic Processes
Cardiovascular Diseases
Parathyroid Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs