Chronic Kidney Disease Stage 3-5Phase 3NCT02199444
Effect of Sevelamer on P-cresol Levels in CKD
A Phase 3 study testing Sevelamer in people with Chronic Kidney Disease Stage 3-5, run by Federico II University at 1 site in Italy.
Trial summary
The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly demanded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 3-5
- What is being tested?
- Sevelamer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to May 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 years,
- CKD stage 3-5
Who cannot join
- Existing or previous treatment within the last 1 year with a phosphate binder;
- hyperphosphatemia (>5.6 mg/dL);
- hypophosphatemia (<2.5 mg/dL);
- malnutrition,
- malignant neoplasms,
- current history of gastrointestinal and/or endocrine diseases.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
federico II university, department of nephrology
Naples, Italy, 80131
eleonora riccio, md, 3396770124, elyriccio@libero.it
eleonora riccio, md
About this study
The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.
- Conditions
- Chronic Kidney Disease Stage 3-5
- Being tested
- Sevelamer, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevelamerDrug
The dose of Sev was 2400 mg (800 mg three times a day) in all patients.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Sevelamer | Experimental | The dose of Sev was 2400 mg (800 mg three times a day) in all patients. Receives: Drug: Sevelamer |
| Placebo | Placebo comparator | The patients received placebo three times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on p-creol levels
The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 3-5Studies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Riccio, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199444
- Sponsor's protocol ID
- P-C Sev
- Status last verified
- Sep 2014
- First submitted
- 22 Jul 2014
- Last updated
- 18 Feb 2015
- Results posted
- 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 40576086
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sevelamer on P-cresol Levels in CKD
- ClinicalTrials.gov ID
- NCT02199444
- Acronym / sponsor ID
- P-C Sev
- Conditions
- Chronic Kidney Disease Stage 3-5
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 24 Jul 2014 (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 accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our study was to evaluate the effect of sevelamer on p-cresol levels in CKD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevelamer | Experimental | Drug: SevelamerThe dose of Sev was 2400 mg (800 mg three times a day) in all patients. |
| Placebo | Placebo comparator | Drug: PlaceboThe patients received placebo three times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age >18 years,
- CKD stage 3-5
Key exclusion criteria (6 listed)
- Existing or previous treatment within the last 1 year with a phosphate binder;
- hyperphosphatemia (>5.6 mg/dL);
- hypophosphatemia (<2.5 mg/dL);
- malnutrition,
- malignant neoplasms,
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 |
|---|---|---|
| SevelamerThe dose of Sev was 2400 mg (800 mg three times a day) in all patients. | Drug | Sevelamer |
| Placebo | Drug | Placebo |
Primary outcome
Effect on p-creol levels
Time frame: 3 months
The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sevelamer in people with Chronic Kidney Disease Stage 3-5, run by Federico II University at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 18 Feb 2015. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact eleonora riccio, md (3396770124, elyriccio@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on p-creol levels (time frame: 3 months). 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 NCT02199444, which also lists 1 linked publication.
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 18 Feb 2015.