Condition category
Urological and Genital Diseases
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
29/07/2013
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 Colin Chue

ORCID ID

Contact details

Department of Cardiovascular Medicine
Medical School

Edgbaston
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

2008-003727-23

ClinicalTrials.gov number

Protocol/serial number

5729

Study information

Scientific title

Does phosphate binding with sevelamer carbonate improve cardiovascular structure and function in patients with early chronic kidney disease?

Acronym

Study hypothesis

Does phosphate binding with sevelamer carbonate improve cardiovascular structure and function in patients with early chronic kidney disease?

Ethics approval

West Midlands Research Ethics Committee approved on the 1st October 2008 (ref: 08/H1208/37)

Study design

Randomised interventional treatment trial

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

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

Phase

Not Specified

Drug names

Sevelamer carbonate

Primary outcome measures

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 trial start date

01/04/2009

Overall trial end date

01/11/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

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

United Kingdom

Trial participating centre

Department of Cardiovascular Medicine
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University Hospital Birmingham NHS Foundation Trust (UK)

Sponsor details

Trust Headquarters
PO Box 9551
Main Drive
Queen Elizabeth Medical Centre
Edgbaston
Birmingham
B15 2PR
United Kingdom

Sponsor type

Government

Website

http://www.uhb.nhs.uk/

Funders

Funder type

Industry

Funder name

Genzyme Corporation (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

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21288351

Publication citations

  1. Protocol

    Chue CD, Townend JN, Steeds RP, Ferro CJ, Evaluating the effects of sevelamer carbonate on cardiovascular structure and function in chronic renal impairment in Birmingham: the CRIB-PHOS randomised controlled trial., Trials, 2011, 12, 1, 30, doi: 10.1186/1745-6215-12-30.

Additional files

Editorial Notes