NCT00806481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2008

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

2.7 years

First QC Date

June 25, 2008

Last Update Submit

November 22, 2011

Conditions

Kidney Failure, ChronicCardiovascular Diseases

Keywords

Phosphate

Outcome Measures

Primary Outcomes (1)

  • Change in left ventricular mass

    36 weeks

Secondary Outcomes (5)

  • Aortic compliance as measured by cardiac magnetic resonance imaging

    36 weeks

  • Arterial stiffness as measured by pulse wave velocity and pulse wave analysis

    36 weeks

  • Arterial elastance as measured by echocardiography

    36 weeks

  • Left ventricular systolic and diastolic elastance measured by echocardiography

    36 weeks

  • Bone density on dual-energy x-ray absorptiometry scanning

    36 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Sevelamer carbonate

2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Sevelamer carbonateDRUG

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

Also known as: Sevelamer carbonate (Renvela)
1
PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Related Publications (2)

  • Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

    PMID: 40576086DERIVED

  • 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.

    PMID: 21288351DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicCardiovascular Diseases

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolyaminesAminesOrganic Chemicals

Study Officials

  • Charles J Ferro, BSc (Hons), MBChB, FRCP, MD

    University Hospital Birmingham NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Nephrologist and Honorary Senior Lecturer

Study Record Dates

First Submitted

June 25, 2008

First Posted

December 10, 2008

Study Start

February 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

GB(1)