Contact information
Type
Scientific
Primary contact
Dr Philip Kalra
ORCID ID
Contact details
H4 Renal Department
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom
+44 (0)161 206 5998
philip.kalra@srft.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2006VAS23
Study information
Scientific title
A randomised controlled trial to examine the effects of calcimimetic therapy on bone and cardiovascular health in end-stage renal disease
Acronym
Study hypothesis
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
Salford and Trafford Local Research Ethics Committee, approved in November 2005 (ref: 05/Q1404/216)
Study design
Multi-centre randomised open-label interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Cinacalcet
Primary outcome measures
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 trial start date
01/08/2006
Overall trial end date
01/07/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/08/2006
Recruitment end date
01/07/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
H4 Renal Department
Salford
M6 8HD
United Kingdom
Sponsor information
Organisation
Salford Royal NHS Foundation Trust (UK)
Sponsor details
c/o Rachel Georgiou
Salford Royal NHS FoundationTrust
Stott Lane
Salford
M6 8HD
United Kingdom
+44 (0)161 206 0475
Rachel.georgiou@manchester.ac.uk
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Amgen, educational grant (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Manchester, Translational Imaging Unit grant (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary