Cardiovascular effects of medical (ie use of calcimimetics) vs surgical parathyroidectomy in dialysis of patients. A prospective randomised trial
| ISRCTN | ISRCTN71926161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71926161 |
| Secondary identifying numbers | N0205164619 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 13/10/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
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
Prof M M Yaqoob
Scientific
Scientific
Renal Unit
Basement West Wing
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
| Phone | +44 020 7377 7480 |
|---|---|
| m.m.yaqoob@qmul.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 1. In patients undergoing dialysis, do calcimimetics reduce calcium deposition in the arteries and thereby reduce risk of cardiovascular events? 2. Is medical parathyroidectomy superior to surgical parathyroidectomy in reducing cardiovascular risks and improving abnormalities of mineral metabolism? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Renal |
| Intervention | Calcimimetics vs surgical parathyroidectomy. Added June 2008: the trial was stopped due to poor recruitment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | calcimimetics |
| Primary outcome measure | Progression of disease as determined by multislice CT coronary calcium scores, Dexa scans pulse wave velocity, and carotid intima media thickness. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 28/03/2005 |
| Completion date | 30/09/2007 |
| Reason abandoned (if study stopped) | Poor recruitment |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 50 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 28/03/2005 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Renal Unit
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Barts and The London NHS Trust (UK)
No information available
Queen Mary University of London - QMUL
No information available
NHS R&D Support Funding
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 |
