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

Primary Purpose

Kidney Failure, Chronic, Cardiovascular Diseases

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Sevelamer carbonate
Placebo
Sponsored by
University Hospital Birmingham NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Kidney Failure, Chronic focused on measuring Phosphate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Birmingham NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in left ventricular mass

Secondary Outcome Measures

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

Full Information

First Posted
June 25, 2008
Last Updated
November 22, 2011
Sponsor
University Hospital Birmingham NHS Foundation Trust
Collaborators
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00806481
Brief Title
Effects of Phosphate Binding With Sevelamer in Stage 3 Chronic Kidney Disease
Official Title
Does Phosphate Binding With Sevelamer Carbonate Improve Cardiovascular Structure and Function in Patients With Early Chronic Kidney Disease?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Birmingham NHS Foundation Trust
Collaborators
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Cardiovascular Diseases
Keywords
Phosphate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Treatment group: treatment with tablets of placebo three times daily for 36 weeks
Intervention Type
Drug
Intervention Name(s)
Sevelamer carbonate
Other Intervention Name(s)
Sevelamer carbonate (Renvela)
Intervention Description
Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Treatment group: treatment with tablets of placebo three times daily for 36 weeks
Primary Outcome Measure Information:
Title
Change in left ventricular mass
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Aortic compliance as measured by cardiac magnetic resonance imaging
Time Frame
36 weeks
Title
Arterial stiffness as measured by pulse wave velocity and pulse wave analysis
Time Frame
36 weeks
Title
Arterial elastance as measured by echocardiography
Time Frame
36 weeks
Title
Left ventricular systolic and diastolic elastance measured by echocardiography
Time Frame
36 weeks
Title
Bone density on dual-energy x-ray absorptiometry scanning
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles J Ferro, BSc (Hons), MBChB, FRCP, MD
Organizational Affiliation
University Hospital Birmingham NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Birmingham NHS Foundation Trust
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21288351
Citation
Chue CD, Townend JN, Steeds RP, Ferro CJ. Evaluating the effects of sevelamer carbonate on cardiovascular structure and function in chronic renal impairment in Birmingham: the CRIB-PHOS randomised controlled trial. Trials. 2011 Feb 2;12:30. doi: 10.1186/1745-6215-12-30.
Results Reference
derived

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

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