Phosphate binding with sevelamer in stage 3 chronic kidney disease
| ISRCTN | ISRCTN35254279 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35254279 |
| EudraCT/CTIS number | 2008-003727-23 |
| Secondary identifying numbers | 5729 |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 01/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Colin Chue
Scientific
Scientific
Department of Cardiovascular Medicine
Medical School
, Edgbaston
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| 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 | Does phosphate binding with sevelamer carbonate improve cardiovascular structure and function in patients with early chronic kidney disease? |
| Study hypothesis | Does phosphate binding with sevelamer carbonate improve cardiovascular structure and function in patients with early chronic kidney disease? |
| Ethics approval(s) | West Midlands Research Ethics Committee approved on the 1st October 2008 (ref: 08/H1208/37) |
| Condition | Topic: Renal and Urogenital; Subtopic: Renal and Urogenital (all Subtopics); Disease: Renal |
| Intervention | Intervention: placebo or 1600 mg sevelamer carbonate with meals. Open label: 4 - 6 weeks Treatment (blinded) phase: 34 - 36 weeks Total treatment time: 40 weeks Follow up length: 10 months Study entry: single randomisation only |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Sevelamer carbonate |
| Primary outcome measure | Left ventricular mass, measured at baseline and at 40 weeks |
| Secondary outcome measures | 1. Aortic compliance as measured on cardiac magnetic resonance imaging (MRI), measured at baseline and at 40 weeks 2. Arterial stiffness, measured at baseline, week 4 - 6 and at 40 weeks |
| Overall study start date | 01/04/2009 |
| Overall study end date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 120 |
| Participant inclusion criteria | 1. Chronic kidney disease (CKD) patients aged 18 - 80 years, either sex 2. CKD stage 3 (glomerular filtration rate [GFR] 30 - 59 ml/min/1.73 m^2) 3. Office blood pressure (BP) controlled to less than 140/90 mmHg for 12 months before entry 4. Total cholesterol less than 5.5 mmol/L |
| Participant exclusion criteria | 1. Existing or previous treatment within 1 year with a phosphate binder or vitamin D analogue 2. Uncontrolled hyperphosphataemia (serum phosphate greater than 1.8 mmol/L) 3. Hypophosphataemia (serum phosphate less than 0.8 mmol/L) 4. Uncontrolled secondary hyperparathyroidism (parathyroid hormone [PTH] greater than 80 pg/ml) 5. Diabetes mellitus 6. Pregnancy 7. Women of childbearing age not on contraception 8. Bowel obstruction 9. Dysphagia/swallowing disorders 10. Severe gastrointestinal motility disorders including severe constipation 11. Previous major gastrointestinal surgery |
| Recruitment start date | 01/04/2009 |
| Recruitment end date | 01/11/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Cardiovascular Medicine
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University Hospital Birmingham NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Trust Headquarters
PO Box 9551
Main Drive
Queen Elizabeth Medical Centre
Edgbaston
Birmingham
B15 2PR
England
United Kingdom
| Website | http://www.uhb.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/014ja3n03 |
Funders
Funder type
Industry
Genzyme Corporation (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 02/02/2011 | Yes | No | |
| Results article | results | 01/04/2013 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/10/2018: Publication reference added.
