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Completed

NCT Number: NCT00806481

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

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.

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Key information

Conditions

Kidney Failure, Chronic Cardiovascular Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevelamer carbonate

Drug

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

Other names: Sevelamer carbonate (Renvela)

Placebo

Drug

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

Primary outcomes

  1. Change in left ventricular mass

    Time frame: 36 weeks

Secondary outcomes

  1. Aortic compliance as measured by cardiac magnetic resonance imaging

    Time frame: 36 weeks

  2. Arterial stiffness as measured by pulse wave velocity and pulse wave analysis

    Time frame: 36 weeks

  3. Arterial elastance as measured by echocardiography

    Time frame: 36 weeks

  4. Left ventricular systolic and diastolic elastance measured by echocardiography

    Time frame: 36 weeks

  5. Bone density on dual-energy x-ray absorptiometry scanning

    Time frame: 36 weeks

Sponsors and collaborators

Lead sponsor

University Hospital Birmingham NHS Foundation Trust

Other

Collaborators

  • Genzyme, a Sanofi Company

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 10, 2008
Registry last updated
Nov 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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