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

NCT ID: NCT01143987

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-02-28

Brief Summary

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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

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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.

Conditions

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Hyperparathyroidism Arterial Stiffness

Keywords

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hyperparathyroidism pulse wave velocity end-stage renal disease arterial stiffness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cinacalcet

Oral cinacalcet

Group Type EXPERIMENTAL

Cinacalcet

Intervention Type DRUG

starting with 25 mg daily dose with titration, maximum dose 100 mg daily

Interventions

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Cinacalcet

starting with 25 mg daily dose with titration, maximum dose 100 mg daily

Intervention Type DRUG

Other Intervention Names

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Sensipar

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Chow Kai Ming

Associate Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kai Ming Chow, MBChB

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong, Prince of Wales Hospital

Locations

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Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 24589316 (View on PubMed)

Other Identifiers

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CRE-2010.084-T

Identifier Type: -

Identifier Source: org_study_id