Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chow Kai Ming, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01143987
First received: June 10, 2010
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

Active parathyroid glands among renal dialysis patients contribute to calcified and hardened blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. The investigators designed an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.


Condition Intervention Phase
Hyperparathyroidism
Arterial Stiffness
Drug: Cinacalcet
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Cinacalcet Treatment on Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Aortic pulse wave velocity after the cinacalcet treatment [ Time Frame: change in aortic pulse wave velocity at 52 weeks from baseline ] [ Designated as safety issue: No ]
    as before


Secondary Outcome Measures:
  • Percent change in the values for parathyroid hormone levels [ Time Frame: within one year of treatment with cinacalcet ] [ Designated as safety issue: No ]
    Blood samples will be stored before and after treatment with cinacalcet for further analysis.

  • Change in calcium levels [ Time Frame: within one year of treatment with cinacalcet ] [ Designated as safety issue: No ]
    as before

  • Aortic pulse wave velocity after the cinacalcet treatment [ Time Frame: change in aortic pulse wave velocity at 26 weeks from baseline ] [ Designated as safety issue: No ]
    as stated in the description of Primary Outcome Measure

  • Change in phosphorus levels [ Time Frame: within one year of cinacalcet treatment ] [ Designated as safety issue: No ]
    as before

  • Change in calcium-phosphorus product [ Time Frame: within one year of cinacalcet treatment ] [ Designated as safety issue: No ]
    as before


Enrollment: 44
Study Start Date: June 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cinacalcet
Oral cinacalcet
Drug: Cinacalcet
starting with 25 mg daily dose with titration, maximum dose 100 mg daily
Other Name: Sensipar

Detailed Description:

Mineral metabolism disturbance and hyperparathyroidism contribute to arterial stiffness and vascular calcification. The vascular damage, in turn, contributes to significant cardiovascular morbidity and mortality of end-stage renal disease patients. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. We design an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • plasma parathyroid hormone level of at least 300 pg/ml (31.8 pmol/L)
  • aged 18 or older on peritoneal dialysis for at least three months
  • willingness to give written consent and comply with the study protocol

Exclusion Criteria:

  • evidence of cancer, active infection or diseases with limited life expectancy
  • diseases known to cause hypercalcaemia
  • adjusted serum calcium level below 2.1 mmol/L (8.4 mg/dL) after correction for albumin
  • participation in another interventional study within last 30 days of randomization
  • history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures
  • patients receiving drugs with a narrow therapeutic index and metabolized by cytochrome P-450 2D6 (which is inhibited by cinacalcet): flecainide, thioridazine and most tricyclic antidepressants
  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: NCT01143987

Locations
Hong Kong
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong, SAR
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Kai Ming Chow, MBChB Chinese University of Hong Kong, Prince of Wales Hospital
  More Information

No publications provided by Chinese University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chow Kai Ming, Associate Consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01143987     History of Changes
Other Study ID Numbers: CRE-2010.084-T
Study First Received: June 10, 2010
Last Updated: November 11, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
hyperparathyroidism
pulse wave velocity
end-stage renal disease
arterial stiffness

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014