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

Arterial Stiffness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143987
• Other study ID #: CRE-2010.084-T
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2010
• Last updated: November 11, 2013
• Start date: June 2010
• Est. completion date: February 2013

Study information

• Verified date: November 2013
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Stiffness
• Hyperparathyroidism
• Hyperparathyroidism, Secondary

Intervention

Drug:
• Cinacalcet
starting with 25 mg daily dose with titration, maximum dose 100 mg daily

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital, Chinese University of Hong Kong	Shatin	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic pulse wave velocity after the cinacalcet treatment	as before	change in aortic pulse wave velocity at 52 weeks from baseline	No
Secondary	Percent change in the values for parathyroid hormone levels	Blood samples will be stored before and after treatment with cinacalcet for further analysis.	within one year of treatment with cinacalcet	No
Secondary	Change in calcium levels	as before	within one year of treatment with cinacalcet	No
Secondary	Aortic pulse wave velocity after the cinacalcet treatment	as stated in the description of Primary Outcome Measure	change in aortic pulse wave velocity at 26 weeks from baseline	No
Secondary	Change in phosphorus levels	as before	within one year of cinacalcet treatment	No
Secondary	Change in calcium-phosphorus product	as before	within one year of cinacalcet treatment	No