Cinacalcet, effects on cardiovascular and bone health in chronic kidney disease (CKD)

ISRCTN	ISRCTN81718275
DOI	https://doi.org/10.1186/ISRCTN81718275
Secondary identifying numbers	2006VAS23

Submission date: 24/04/2008
Registration date: 31/07/2008
Last edited: 06/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Philip Kalra
Scientific

H4 Renal Department
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom

Phone	+44 (0)161 206 5998
Email	philip.kalra@srft.nhs.uk

Study information

Study design	Multi-centre randomised open-label interventional study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial to examine the effects of calcimimetic therapy on bone and cardiovascular health in end-stage renal disease
Study objectives	Null hypothesis: Cinacalcet will have no effect on the change of bone and cardiovascular parameters, compared to standard therapy, in haemodialysis patients over a 12 month period.
Ethics approval(s)	Salford and Trafford Local Research Ethics Committee, approved in November 2005 (ref: 05/Q1404/216)
Health condition(s) or problem(s) studied	Patients with uncontrolled secondary hyperparathyroidism and who are on haemodialysis
Intervention	Intervention arm: Cinacalcet (oral) alongside standard therapy. Dose of cinacalcet will be adjusted according to PTH and calcium, within the range of 30-180 mg daily. Control arm: Standard therapy alone. Standard therapy includes vitamin D analogues and all available phosphate binders. Duration of interventions: 12 months
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Cinacalcet
Primary outcome measure	The change of calcification score between the 2 cohorts at baseline and 12 months
Secondary outcome measures	The change in the following will be compared between the 2 arms at baseline and 12 months: 1. Vascular stiffness 2. Cardiac morphology 3. Cardiac function 4. Bone mineral density 5. Carotid Intima Media Thickness (CIMT) 6. Serum markers
Overall study start date	01/08/2006
Completion date	01/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	Both
Target number of participants	40
Key inclusion criteria	1. Age 18-75 at recruitment, both male and female 2. On haemodialysis for >90 days 3. Parathyroid hormone (PTH) >=300 pg/ml 4. Corrected calcium >=2.1 mmol/l
Key exclusion criteria	1. Atrial fibrillation 2. Any contra-indications to magnetic resonance (MR) scan or ability to cooperate with scan 3. Any factors which will influence computed tomography (CT) scan e.g. artificial heart valves, previous sternotomy wires, stents 4. Contra-indication to cinacalcet e.g., pregnant, breast feeding, known reaction 5. Moderate to severe liver disease (alanine transaminase [ALT] >3x normal) 6. Have a poor record of compliance with medication 7. Have participated in a study involving an investigational drug during the 30 days prior to the first visit 8. Be involved in any other research study which exposes the patient to radiation above that of normal clinical practice
Date of first enrolment	01/08/2006
Date of final enrolment	01/07/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

H4 Renal Department

Salford
M6 8HD
United Kingdom

Sponsor information

Salford Royal NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Rachel Georgiou
Salford Royal NHS FoundationTrust
Stott Lane
Salford
M6 8HD
England
United Kingdom

Phone	+44 (0)161 206 0475
Email	Rachel.georgiou@manchester.ac.uk
Website	http://www.srht.nhs.uk
"ROR"	https://ror.org/019j78370

Funders

Funder type

Industry

Amgen, educational grant (USA)

No information available

University of Manchester, Translational Imaging Unit grant (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

06/05/2016: No publications found, verifying study status with principal investigator.