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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT01143987

Collaborator

(none)

Enrollment

Location

Arm

32.1

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperparathyroidism Arterial Stiffness	Drug: Cinacalcet	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Aortic pulse wave velocity after the cinacalcet treatment [change in aortic pulse wave velocity at 52 weeks from baseline]
as before

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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