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

Phase 2

Completed

• Conditions: Kidney Failure, Chronic; Cardiovascular Diseases
• Interventions: Drug: Placebo; Drug: Sevelamer carbonate

• Registration Number: NCT00806481
• Lead Sponsor: University Hospital Birmingham NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-25
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Study Start: 2009-02
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-22
• Last Update Posted: 2011-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Treatment group: treatment with tablets of placebo three times daily for 36 weeks
1	Sevelamer carbonate	Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks

Primary Outcome Measures

Name	Time	Method
Change in left ventricular mass	36 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, West Midlands, United Kingdom