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 |
| Protocol serial number | N0205164619 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Barts and The London NHS Trust (UK), Queen Mary University of London - QMUL, NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | calcimimetics |
| Primary outcome measure(s) |
Progression of disease as determined by multislice CT coronary calcium scores, Dexa scans pulse wave velocity, and carotid intima media thickness. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
Renal Unit
London
E1 1BB
United Kingdom
E1 1BB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
