Phosphate binding with sevelamer in stage 3 chronic kidney disease

ISRCTN	ISRCTN35254279
DOI	https://doi.org/10.1186/ISRCTN35254279
Clinical Trials Information System (CTIS)	2008-003727-23
Protocol serial number	5729
Sponsor	University Hospital Birmingham NHS Foundation Trust (UK)
Funder	Genzyme Corporation (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Colin Chue
Scientific

Department of Cardiovascular Medicine
Medical School
, Edgbaston
Birmingham
B15 2TT
United Kingdom

Primary study design	Interventional
Study design	Randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Does phosphate binding with sevelamer carbonate improve cardiovascular structure and function in patients with early chronic kidney disease?
Study objectives	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)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Sevelamer carbonate
Primary outcome measure(s)	Left ventricular mass, measured at baseline and at 40 weeks
Key secondary outcome measure(s)	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
Completion date	01/11/2010

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key 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
Key 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
Date of first enrolment	01/04/2009
Date of final enrolment	01/11/2010

Department of Cardiovascular Medicine

Birmingham
B15 2TT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2013		Yes	No
Protocol article	protocol	02/02/2011		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

01/10/2018: Publication reference added.