Status:
COMPLETED
Effects of Phosphate Binding With Sevelamer in Stage 3 Chronic Kidney Disease
Lead Sponsor:
University Hospital Birmingham NHS Foundation Trust
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Kidney Failure, Chronic
Cardiovascular Diseases
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 structur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00806481
Start Date
February 1 2009
End Date
October 1 2011
Last Update
November 23 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2TH