Effects of Phosphate Binding With Sevelamer in Stage 3 Chronic Kidney Disease

Condition(s) targeted: Kidney Failure, Chronic; Cardiovascular Diseases

Intervention: Sevelamer carbonate (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Birmingham NHS Foundation Trust

Official(s) and/or principal investigator(s):
Charles J Ferro, BSc (Hons), MBChB, FRCP, MD, Principal Investigator, Affiliation: University Hospital Birmingham NHS Foundation Trust

Overall contact:
Charles J Ferro, BSc MBChB MD, Phone: +44 1216272528, Email: charles.ferro@uhb.nhs.uk

The purpose of this study is to determine whether lowering phosphate in patients with early chronic kidney disease with the phosphate binder sevelamer has beneficial effects on cardiovascular structure and function.

Official title: Does Phosphate Binding With Sevelamer Carbonate Improve Cardiovascular Structure and Function in Patients With Early Chronic Kidney Disease?

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Change in left ventricular mass

Secondary outcome:

Aortic compliance as measured by cardiac magnetic resonance imaging

Arterial stiffness as measured by pulse wave velocity and pulse wave analysis

Arterial elastance as measured by echocardiography

Left ventricular systolic and diastolic elastance measured by echocardiography

Bone density on dual-energy x-ray absorptiometry scanning

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Chronic kidney disease patients aged 18 to 80 years

- Chronic kidney disease stage 3 (defined as a glomerular filtration rate of 30-60

ml/min/1. 73m2)

- Office blood pressure controlled to less than 140/90 mmHg for 12 months before entry

into the study

- Total cholesterol less than 5. 5 mmol/l

Exclusion Criteria:

- Existing or previous treatment within 1 year with a phosphate binder or vitamin D

analogue

- Uncontrolled hyperphosphataemia (serum phosphate >1. 8 mmol/l)

- Uncontrolled secondary hyperparathyroidism (PTH >80 pg/ml)

- Diabetes mellitus

- Pregnancy

- Moderate-severe cardiac valvular disease

Charles J Ferro, BSc MBChB MD, Phone: +44 1216272528, Email: charles.ferro@uhb.nhs.uk

University Hospital Birmingham NHS Foundation Trust, Birmingham, West Midlands B15 2TH, United Kingdom; Recruiting
Charles J Ferro, BSc (Hons), MBChB, FRCP, MD, Phone: +44 1216272528, Email: charles.ferro@uhb.nhs.uk
Jonathan N Townend, BSc, MBChB, MD, FRCP, FESC, Phone: +44 121 978476, Email: john.townend@uhb.nhs.uk
Charles J Ferro, BSc MBChB MD, Principal Investigator
Jonathan N Townend, BSc MBChB MD, Sub-Investigator
Rick P Steeds, MA MD, Sub-Investigator
Colin D Chue, MBChB (Hons), Sub-Investigator

Starting date: February 2009
Last updated: January 11, 2010