Kidney Failure, ChronicPhase 2NCT00806481
Effects of Phosphate Binding With Sevelamer in Stage 3 Chronic Kidney Disease
A Phase 2 study testing Sevelamer carbonate in people with Kidney Failure, Chronic and Cardiovascular Diseases, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Failure, Chronic, Cardiovascular Diseases
- What is being tested?
- Sevelamer carbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2009to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2TH
About this study
Official title: 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.
- Conditions
- Kidney Failure, Chronic, Cardiovascular Diseases
- Being tested
- Sevelamer carbonate, Placebo
- Keywords
- Phosphate
- Medical subject headings
- Kidney Failure, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevelamer carbonateDrug
Also called Sevelamer carbonate (Renvela)
Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks
PlaceboDrug
Treatment group: treatment with tablets of placebo three times daily for 36 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks Receives: Drug: Sevelamer carbonate |
| 2 | Placebo comparator | Treatment group: treatment with tablets of placebo three times daily for 36 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular mass
Measured: 36 weeks
Secondary outcomes (5)
Aortic compliance as measured by cardiac magnetic resonance imaging
Measured: 36 weeks
Arterial stiffness as measured by pulse wave velocity and pulse wave analysis
Measured: 36 weeks
Arterial elastance as measured by echocardiography
Measured: 36 weeks
Left ventricular systolic and diastolic elastance measured by echocardiography
Measured: 36 weeks
Bone density on dual-energy x-ray absorptiometry scanning
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Principal investigator, Charles Ferro, Dr, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Charles J Ferro, BSc (Hons), MBChB, FRCP, MD, Principal investigator, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00806481
- Sponsor's protocol ID
- RRK3563
- Other IDs
- SVCARB01508IST, 2008-003727-23, 2008
- Status last verified
- Nov 2011
- First submitted
- 25 Jun 2008
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40576086Chue 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.
PubMed 21288351
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Phosphate Binding With Sevelamer Carbonate Improve Cardiovascular Structure and Function in Patients With Early Chronic Kidney Disease?
- ClinicalTrials.gov ID
- NCT00806481
- Acronym / sponsor ID
- RRK3563
- Conditions
- Kidney Failure, Chronic, Cardiovascular Diseases
- Keywords
- Phosphate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Feb 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Sevelamer carbonateTreatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks |
| 2 | Placebo comparator | Drug: PlaceboTreatment group: treatment with tablets of placebo three times daily for 36 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevelamer carbonateAlso: Sevelamer carbonate (Renvela)Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks | Drug | 1 |
| PlaceboTreatment group: treatment with tablets of placebo three times daily for 36 weeks | Drug | 2 |
Primary outcome
Change in left ventricular mass
Time frame: 36 weeks
5 secondary outcomes
Aortic compliance as measured by cardiac magnetic resonance imaging
Time frame: 36 weeks
Arterial stiffness as measured by pulse wave velocity and pulse wave analysis
Time frame: 36 weeks
Arterial elastance as measured by echocardiography
Time frame: 36 weeks
Left ventricular systolic and diastolic elastance measured by echocardiography
Time frame: 36 weeks
Bone density on dual-energy x-ray absorptiometry scanning
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2011.
- Derived from this study: PubMed 40576086Natale 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.
- Derived from this study: PubMed 21288351Chue 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles J Ferro, BSc (Hons), MBChB, FRCP, MD principal investigator
University Hospital Birmingham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sevelamer carbonate in people with Kidney Failure, Chronic and Cardiovascular Diseases, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular mass (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00806481, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2011.