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

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Charles Ferro, Dr, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00806481
First received: June 25, 2008
Last updated: November 22, 2011
Last verified: November 2011
  Purpose
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 Intervention Phase
Kidney Failure, Chronic Cardiovascular Diseases Drug: Sevelamer carbonate Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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?

Resource links provided by NLM:


Further study details as provided by Charles Ferro, Dr, University Hospital Birmingham NHS Foundation Trust:

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

Secondary Outcome Measures:
  • Aortic compliance as measured by cardiac magnetic resonance imaging [ Time Frame: 36 weeks ]
  • Arterial stiffness as measured by pulse wave velocity and pulse wave analysis [ Time Frame: 36 weeks ]
  • Arterial elastance as measured by echocardiography [ Time Frame: 36 weeks ]
  • Left ventricular systolic and diastolic elastance measured by echocardiography [ Time Frame: 36 weeks ]
  • Bone density on dual-energy x-ray absorptiometry scanning [ Time Frame: 36 weeks ]

Enrollment: 120
Study Start Date: February 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806481

Locations
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
Principal Investigator: Charles J Ferro, BSc (Hons), MBChB, FRCP, MD University Hospital Birmingham NHS Foundation Trust
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charles Ferro, Dr, Consultant Nephrologist and Honorary Senior Lecturer, University Hospital Birmingham NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00806481     History of Changes
Other Study ID Numbers: RRK3563
SVCARB01508IST
2008-003727-23
Study First Received: June 25, 2008
Last Updated: November 22, 2011

Keywords provided by Charles Ferro, Dr, University Hospital Birmingham NHS Foundation Trust:
Phosphate

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 26, 2017