MedDataX Logo

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

NCT ID: NCT00806481

Last Updated: 2011-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Failure, Chronic Cardiovascular Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Phosphate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type ACTIVE_COMPARATOR

Sevelamer carbonate

Intervention Type DRUG

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

2

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sevelamer carbonate

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sevelamer carbonate (Renvela)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Charles Ferro, Dr

Consultant Nephrologist and Honorary Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Role: PRINCIPAL_INVESTIGATOR

University Hospital Birmingham NHS Foundation Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Birmingham NHS Foundation Trust

Birmingham, West Midlands, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40576086 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21288351 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SVCARB01508IST

Identifier Type: -

Identifier Source: secondary_id

2008-003727-23

Identifier Type: -

Identifier Source: secondary_id

RRK3563

Identifier Type: -

Identifier Source: org_study_id