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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00806481

Enrollment

120

Registered

2008-12-10

Start date

2009-02-28

Completion date

2011-10-31

Last updated

2011-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Kidney Failure, Chronic

Keywords

Phosphate

Brief summary

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.

Interventions

DRUGSevelamer carbonate

Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks

DRUGPlacebo

Treatment group: treatment with tablets of placebo three times daily for 36 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in left ventricular mass	36 weeks

Secondary

Measure	Time frame
Aortic compliance as measured by cardiac magnetic resonance imaging	36 weeks
Arterial stiffness as measured by pulse wave velocity and pulse wave analysis	36 weeks
Arterial elastance as measured by echocardiography	36 weeks
Left ventricular systolic and diastolic elastance measured by echocardiography	36 weeks
Bone density on dual-energy x-ray absorptiometry scanning	36 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026