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

This study has been completed.
Sponsor:
Collaborator:
Genzyme
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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University Hospital Birmingham NHS Foundation Trust:

Primary Outcome Measures:
  • Change in left ventricular mass [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Aortic compliance as measured by cardiac magnetic resonance imaging [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Arterial stiffness as measured by pulse wave velocity and pulse wave analysis [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Arterial elastance as measured by echocardiography [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Left ventricular systolic and diastolic elastance measured by echocardiography [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Bone density on dual-energy x-ray absorptiometry scanning [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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
Investigators
Principal Investigator: Charles J Ferro, BSc (Hons), MBChB, FRCP, MD University Hospital Birmingham NHS Foundation Trust
  More Information

No publications provided by University Hospital Birmingham NHS Foundation Trust

Additional 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
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospital Birmingham NHS Foundation Trust:
Phosphate

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

ClinicalTrials.gov processed this record on May 19, 2013