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

University Hospital Birmingham NHS Foundation Trust

Status and phase: Completed; Phase 2

Conditions: Cardiovascular Diseases; Kidney Failure, Chronic

Treatments: Drug: Placebo; Drug: Sevelamer carbonate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00806481

2008-003727-23

SVCARB01508IST

RRK3563

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Drug: Sevelamer carbonate

2

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo