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

November 11, 2013 updated by: Chow Kai Ming, Chinese University of Hong Kong

Effect of Cinacalcet Treatment on Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • New Territories
      • Shatin, New Territories, Hong Kong, SAR
        • Prince of Wales Hospital, Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cinacalcet
Oral cinacalcet
Drug: Cinacalcet
starting with 25 mg daily dose with titration, maximum dose 100 mg daily
Other Names:
  • Sensipar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aortic pulse wave velocity after the cinacalcet treatment
Time Frame: change in aortic pulse wave velocity at 52 weeks from baseline
as before
change in aortic pulse wave velocity at 52 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent change in the values for parathyroid hormone levels
Time Frame: within one year of treatment with cinacalcet
Blood samples will be stored before and after treatment with cinacalcet for further analysis.
within one year of treatment with cinacalcet
Change in calcium levels
Time Frame: within one year of treatment with cinacalcet
as before
within one year of treatment with cinacalcet
Aortic pulse wave velocity after the cinacalcet treatment
Time Frame: change in aortic pulse wave velocity at 26 weeks from baseline
as stated in the description of Primary Outcome Measure
change in aortic pulse wave velocity at 26 weeks from baseline
Change in phosphorus levels
Time Frame: within one year of cinacalcet treatment
as before
within one year of cinacalcet treatment
Change in calcium-phosphorus product
Time Frame: within one year of cinacalcet treatment
as before
within one year of cinacalcet treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Kai Ming Chow, MBChB, Chinese University of Hong Kong, Prince of Wales Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 11, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2010.084-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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