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

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Birmingham NHS Foundation Trust
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Sevelamer

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