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

Primary Purpose

Hyperparathyroidism, Arterial Stiffness

Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Cinacalcet
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperparathyroidism focused on measuring hyperparathyroidism, pulse wave velocity, end-stage renal disease, arterial stiffness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital, Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cinacalcet

Arm Description

Oral cinacalcet

Outcomes

Primary Outcome Measures

Aortic pulse wave velocity after the cinacalcet treatment
as before

Secondary Outcome Measures

Percent change in the values for parathyroid hormone levels
Blood samples will be stored before and after treatment with cinacalcet for further analysis.
Change in calcium levels
as before
Aortic pulse wave velocity after the cinacalcet treatment
as stated in the description of Primary Outcome Measure
Change in phosphorus levels
as before
Change in calcium-phosphorus product
as before

Full Information

First Posted
June 10, 2010
Last Updated
November 11, 2013
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01143987
Brief Title
Cincalcet and Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism
Official Title
Effect of Cinacalcet Treatment on Vascular Arterial Stiffness Among Peritoneal Dialysis Patients With Secondary Hyperparathyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Arterial Stiffness
Keywords
hyperparathyroidism, pulse wave velocity, end-stage renal disease, arterial stiffness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cinacalcet
Arm Type
Experimental
Arm Description
Oral cinacalcet
Intervention Type
Drug
Intervention Name(s)
Cinacalcet
Other Intervention Name(s)
Sensipar
Intervention Description
starting with 25 mg daily dose with titration, maximum dose 100 mg daily
Primary Outcome Measure Information:
Title
Aortic pulse wave velocity after the cinacalcet treatment
Description
as before
Time Frame
change in aortic pulse wave velocity at 52 weeks from baseline
Secondary Outcome Measure Information:
Title
Percent change in the values for parathyroid hormone levels
Description
Blood samples will be stored before and after treatment with cinacalcet for further analysis.
Time Frame
within one year of treatment with cinacalcet
Title
Change in calcium levels
Description
as before
Time Frame
within one year of treatment with cinacalcet
Title
Aortic pulse wave velocity after the cinacalcet treatment
Description
as stated in the description of Primary Outcome Measure
Time Frame
change in aortic pulse wave velocity at 26 weeks from baseline
Title
Change in phosphorus levels
Description
as before
Time Frame
within one year of cinacalcet treatment
Title
Change in calcium-phosphorus product
Description
as before
Time Frame
within one year of cinacalcet treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Ming Chow, MBChB
Organizational Affiliation
Chinese University of Hong Kong, Prince of Wales Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital, Chinese University of Hong Kong
City
Shatin
State/Province
New Territories
ZIP/Postal Code
SAR
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
24589316
Citation
Chow KM, Szeto CC, Kwan BC, Cheng PM, Pang WF, Leung CB, Li PK. Effect of cinacalcet treatment on vascular arterial stiffness among peritoneal dialysis patients with secondary hyperparathyroidism. Nephrology (Carlton). 2014 Jun;19(6):339-44. doi: 10.1111/nep.12223.
Results Reference
derived

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

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