Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/04/2008
Date assigned
31/07/2008
Last edited
06/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.srht.nhs.uk

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

Publication citations

Additional files

Editorial Notes

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