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

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ClinicalTrials.gov Identifier: NCT00806481
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : November 23, 2011
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Charles Ferro, Dr, University Hospital Birmingham NHS Foundation Trust

Study Description
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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 structure and function.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Cardiovascular Diseases Drug: Sevelamer carbonate Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Phosphate Binding With Sevelamer Carbonate Improve Cardiovascular Structure and Function in Patients With Early Chronic Kidney Disease?
Study Start Date : February 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks
 Drug: Sevelamer carbonate
Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks
Other Name: Sevelamer carbonate (Renvela)
Placebo Comparator: 2
Treatment group: treatment with tablets of placebo three times daily for 36 weeks
 Drug: Placebo
Treatment group: treatment with tablets of placebo three times daily for 36 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in left ventricular mass [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806481


Locations
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United Kingdom
University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2TH
Sponsors and Collaborators
University Hospital Birmingham NHS Foundation Trust
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: Charles J Ferro, BSc (Hons), MBChB, FRCP, MD University Hospital Birmingham NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Charles Ferro, Dr, Consultant Nephrologist and Honorary Senior Lecturer, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00806481    
Other Study ID Numbers: RRK3563
SVCARB01508IST
2008-003727-23
First Posted: December 10, 2008    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011
Keywords provided by Charles Ferro, Dr, University Hospital Birmingham NHS Foundation Trust:
Phosphate
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Cardiovascular Diseases
 Urologic Diseases
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action