A randomised control trial to identify the effects of cinacalcet on bone and cardiovascular health in end-stage renal disease - cinacalcet study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003871-19-GB

Enrollment

Registered

2005-10-11

Start date

2006-09-19

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary hyperparathyroidism in renal failure

Interventions

Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: on renal replacement therapy Corrected calcium >2.2 mmol/l Parathyroidhormone > 300pg/ml Age 18-75 yrs Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Contraindication to MR or CT scan Atrial fibrillation contraindication to cincalcet moderate to severe liver disease (ALT x3 normal)

Design outcomes

Primary

Measure	Time frame
Main Objective: Cinacalcet is a new calcium sensing receptor agonist already licensed for use in secondary hyperparathyroidism. Our patients have a 20% mortality due to cardiovascular disease. We want to see if this drug affects vascular calcification, cardiac structure and bone density and therefore may help improve the mortality of our patients. We think this may occur as calcium receptors are present throughout the body. As it is too expensive to use in the general renal population we want to randomise our patients to compare this to standard treatment alone. We are going to do this in 40 patients, 20 in each cohort. We are then going to study vascular stiffness and calcification with CT and pulse wave velocity, cardiac structure with cardiac magnetic resonance scans and bone density using DEXA and CT. We will be comparing the change in these factors to serological markers of calcification. The patients will have investigations at the beginning and end of the 1 year study.;Secondary Objective: ;Primary end point(s): Percentage change in vascular calcification score as determined by the CT scan.	—

Measure

Time frame

Main Objective: Cinacalcet is a new calcium sensing receptor agonist already licensed for use in secondary hyperparathyroidism. Our patients have a 20% mortality due to cardiovascular disease. We want to see if this drug affects vascular calcification, cardiac structure and bone density and therefore may help improve the mortality of our patients. We think this may occur as calcium receptors are present throughout the body. As it is too expensive to use in the general renal population we want to randomise our patients to compare this to standard treatment alone. We are going to do this in 40 patients, 20 in each cohort. We are then going to study vascular stiffness and calcification with CT and pulse wave velocity, cardiac structure with cardiac magnetic resonance scans and bone density using DEXA and CT. We will be comparing the change in these factors to serological markers of calcification. The patients will have investigations at the beginning and end of the 1 year study.;Secondary Objective: ;Primary end point(s): Percentage change in vascular calcification score as determined by the CT scan.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026