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

November 22, 2011 updated by: Charles Ferro, Dr, University Hospital Birmingham NHS Foundation Trust

Does Phosphate Binding With Sevelamer Carbonate Improve Cardiovascular Structure and Function in Patients With Early 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • University Hospital Birmingham NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in left ventricular mass
Time Frame: 36 weeks
36 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham NHS Foundation Trust

Collaborators

Genzyme, a Sanofi Company

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 25, 2008

First Submitted That Met QC Criteria

December 9, 2008

First Posted (Estimate)

December 10, 2008

Study Record Updates

Last Update Posted (Estimate)

November 23, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK3563
  • SVCARB01508IST
  • 2008-003727-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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