Vascular DiseasesPhase 4NCT00486772
Sevelamer, Fetuin-A and Endothelial Dysfunction in CKD
A Phase 4 study testing Sevelamer (Renagel), calcium acetate (Phos-ex) in people with Vascular Diseases, run by Gulhane School of Medicine.
Trial summary
Vascular calcification and endothelial dysfunction (ED) contribute to the development of cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification in CKD patients while the exact mechanism has… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Sevelamer (Renagel), calcium acetate (Phos-ex)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD stage 4 patients
- Older than 18 years of age
- Non-diabetic
- Serum phosphorus > 5.5 mg/dl
Who cannot join
- Diabetes mellitus
- History of coronary artery disease
- Smokers
- Taking statins or renin-angiotensin blockers
About this study
Vascular calcification and endothelial dysfunction (ED) contribute to the development of cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification in CKD patients while the exact mechanism has not been clarified.
This study was designed to investigate the effect of short-term sevelamer treatment on both serum fetuin-A concentrations and ED seen in CKD patients.
Read the detailed description
CKD stage 4 patients older than 18 years of age and willing to participate to the study were screened. Those who had serum phosphorus > 5.5 mg/dl were evaluated for the study. Patients with diabetes mellitus, history of coronary artery disease, smokers and those taking statins or renin-angiotensin blockers were excluded because of the effect of these factors on endothelial dysfunction. Of 62 screened patients 50 met the study criteria and were included in this study. Thirty-two healthy subjects were studied as controls. The ethical committee of Gulhane School of Medicine approved the study and written informed consent was obtained from all patients.
Study design:
This was a randomized study conducted from 2005 through 2006 in Gulhane School of Medicine. The Outpatient Clinic of Department of Nephrology is a tertiary referral center. At admission, most patients were untreated (including phosphate binders) or treated only with antihypertensive agents. After the first evaluation, patients receiving phosphate binders (n=9) underwent a 2-week washout period. Patients who developed a phosphate level >5.5 mg/dl during this period were included in the study. Patients were randomly assigned in 1:1 ratio to receive sevelamer (Renagel capsule) or calcium acetate (Phos Ex tablet). The treatment phase was 8 weeks. During the study period serum calcium and phosphorus concentration were measured every 2 weeks and the dose of phosphate binders were titrated to achieve a serum phosphorus concentration < 5.5 mg/dl. The starting dose for sevelamer was 1-2 capsules (800 mg) three times a day and for calcium acetate (1000 mg) 1 tablet three times a day. The medications were given with meal and the doses were increased as needed. Patients were not given calcitriol during the study period.
Fasting blood samples were taken before and after the study to measure serum creatinine, serum albumin, hs-CRP, insulin, iPTH, lipid profile and serum fetuin-A concentration. Additionally, flow-mediated dilatation (FMD) was also evaluated before and after the study.
- Conditions
- Vascular Diseases
- Being tested
- Sevelamer (Renagel), calcium acetate (Phos-ex)
- Keywords
- This study was designed to investigate whether the suggested beneficial effects of sevelamer on VC were related to fetuin-A levels in patients with CKD.
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevelamer (Renagel), calcium acetate (Phos-ex)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2007 (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 Vascular DiseasesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Mahmut I Yilmaz, Principal investigator, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486772
- Sponsor's protocol ID
- 1-Yilmaz
- Status last verified
- Jun 2007
- First submitted
- 13 Jun 2007
- Last updated
- 19 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Caglar K, Yilmaz MI, Saglam M, Cakir E, Acikel C, Eyileten T, Yenicesu M, Oguz Y, Vural A, Carrero JJ, Axelsson J, Lindholm B, Stenvinkel P. Short-term treatment with sevelamer increases serum fetuin-a concentration and improves endothelial dysfunction in chronic kidney disease stage 4 patients. Clin J Am Soc Nephrol. 2008 Jan;3(1):61-8. doi: 10.2215/CJN.02810707. Epub 2007 Dec 5.
PubMed 18057307
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevelamer, Fetuin-A and Endothelial Dysfunction in CKD
- ClinicalTrials.gov ID
- NCT00486772
- Acronym / sponsor ID
- 1-Yilmaz
- Conditions
- Vascular Diseases
- Keywords
- This study was designed to investigate whether the suggested beneficial effects of sevelamer on VC were related to fetuin-A levels in patients with CKD.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- First posted
- 15 Jun 2007 (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.
Vascular calcification and endothelial dysfunction (ED) contribute to the development of cardiovascular disease (CVD) in patients with chronic kidney disease (CKD). Sevelamer, a non-calcium based phosphate binder, has been shown to attenuate cardiovascular calcification in CKD patients while the exact mechanism has not been clarified.
This study was designed to investigate the effect of short-term sevelamer treatment on both serum fetuin-A concentrations and ED seen in CKD patients.
Detailed description
CKD stage 4 patients older than 18 years of age and willing to participate to the study were screened. Those who had serum phosphorus > 5.5 mg/dl were evaluated for the study. Patients with diabetes mellitus, history of coronary artery disease, smokers and those taking statins or renin-angiotensin blockers were excluded because of the effect of these factors on endothelial dysfunction. Of 62 screened patients 50 met the study criteria and were included in this study. Thirty-two healthy subjects were studied as controls. The ethical committee of Gulhane School of Medicine approved the study and written informed consent was obtained from all patients.
Study design:
This was a randomized study conducted from 2005 through 2006 in Gulhane School of Medicine. The Outpatient Clinic of Department of Nephrology is a tertiary referral center. At admission, most patients were untreated (including phosphate binders) or treated only with antihypertensive agents. After the first evaluation, patients receiving phosphate binders (n=9) underwent a 2-week washout period. Patients who developed a phosphate level >5.5 mg/dl during this period were included in the study. Patients were randomly assigned in 1:1 ratio to receive sevelamer (Renagel capsule) or calcium acetate (Phos Ex tablet). The treatment phase was 8 weeks. During the study period serum calcium and phosphorus concentration were measured every 2 weeks and the dose of phosphate binders were titrated to achieve a serum phosphorus concentration < 5.5 mg/dl. The starting dose for sevelamer was 1-2 capsules (800 mg) three times a day and for calcium acetate (1000 mg) 1 tablet three times a day. The medications were given with meal and the doses were increased as needed. Patients were not given calcitriol during the study period.
Fasting blood samples were taken before and after the study to measure serum creatinine, serum albumin, hs-CRP, insulin, iPTH, lipid profile and serum fetuin-A concentration. Additionally, flow-mediated dilatation (FMD) was also evaluated before and after the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CKD stage 4 patients
- Older than 18 years of age
- Non-diabetic
- Serum phosphorus > 5.5 mg/dl
Key exclusion criteria (4 listed)
- Diabetes mellitus
- History of coronary artery disease
- Smokers
- Taking statins or renin-angiotensin blockers
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 (Renagel), calcium acetate (Phos-ex) | Drug | – |
Primary outcome
Not reported in the source record.
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 19 Jun 2007.
- Derived from this study: PubMed 18057307Caglar K, Yilmaz MI, Saglam M, Cakir E, Acikel C, Eyileten T, Yenicesu M, Oguz Y, Vural A, Carrero JJ, Axelsson J, Lindholm B, Stenvinkel P. Short-term treatment with sevelamer increases serum fetuin-a concentration and improves endothelial dysfunction in chronic kidney disease stage 4 patients. Clin J Am Soc Nephrol. 2008 Jan;3(1):61-8. doi: 10.2215/CJN.02810707. Epub 2007 Dec 5.
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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.
Mahmut I Yilmaz principal investigator
Gulhane School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevelamer (Renagel), calcium acetate (Phos-ex) in people with Vascular Diseases, run by Gulhane School of Medicine.
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 4 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 19 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00486772, 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 19 Jun 2007; AzTrials last refreshed its copy on 26 Oct 2026.