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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806481
• Other study ID #: RRK3563
• Secondary ID: SVCARB01508IST20
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2008
• Last updated: November 22, 2011
• Start date: February 2009
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: University Hospital Birmingham NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sevelamer carbonate
Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks
• Placebo
Treatment group: treatment with tablets of placebo three times daily for 36 weeks

Locations

Country	Name	City	State
United Kingdom	University Hospital Birmingham NHS Foundation Trust	Birmingham	West Midlands

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Birmingham NHS Foundation Trust	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular mass		36 weeks	No
Secondary	Aortic compliance as measured by cardiac magnetic resonance imaging		36 weeks	No
Secondary	Arterial stiffness as measured by pulse wave velocity and pulse wave analysis		36 weeks	No
Secondary	Arterial elastance as measured by echocardiography		36 weeks	No
Secondary	Left ventricular systolic and diastolic elastance measured by echocardiography		36 weeks	No
Secondary	Bone density on dual-energy x-ray absorptiometry scanning		36 weeks	No