Chronic Kidney DiseasePhase 4NCT01277497
Effect of Phosphate Binders on Markers of Vascular Health in Chronic Kidney Disease Stages 3 and 4
A Phase 4 study testing Sevelamer carbonate and Calcium acetate in people with Chronic Kidney Disease, run by Albany College of Pharmacy and Health Sciences at 1 site in United States.
Trial summary
Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and as a result phosphorus accumulates in the blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Sevelamer carbonate and Calcium acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥ 18 years of age at start of screening
- CKD stage 3 or 4 defined by an eGFR 15 - 60 mL/min/1.73m2
- Not expected to start dialysis for 8 months
- Serum intact PTH < 500 pg/mL during screening period
- On a stable ACE inhibitor/ARB regimen for 30 days prior to screening
Who cannot join
- History of any of the following diseases: congestive heart failure, MI within the last 6 months, cerebrovascular accident, significant valvular disease, malignancy
- Currently receiving erythropoiesis stimulating agent or IV iron therapy
- History of inflammatory/autoimmune disease
- History of polycystic kidney disease
- HIV positive or AIDS
- Pregnant or breastfeeding
Show all 9Show fewer
- Receiving activated Vitamin D analogs, nutritional vitamin D agents > 2,000 IU/day, or calcimimetics with in the last 3 months
- Significant GI disorder
- Proteinuria >3.5 g/24 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Albany Medical Center South Clinical Campus
Albany, New York, 12208
About this study
Official title: A Randomized Study on the Effects of Sevelamer Carbonate Versus Calcium Acetate on Biomarkers of Vascular Calcification, Inflammation, and Endothelial Dysfunction in Chronic Kidney Disease Stages 3 and 4
Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and as a result phosphorus accumulates in the blood. In response to elevated phosphorus levels, more FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine. In addition to effects on FGF-23, increased phosphorus levels can lead to calcification (hardening) of the blood vessels in the CKD population.
Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD, studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering FGF-23 levels in CKD patients may also lower substances in the blood that cause calcification of blood vessels in the CKD population.
This study is being done to determine if using phosphate binders, either sevelamer carbonate or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood vessels and heart disease.
- Conditions
- Chronic Kidney Disease
- Being tested
- Sevelamer carbonate, Calcium acetate
- Keywords
- Chronic kidney disease, Phosphate binder, Sevelamer carbonate, Calcium acetate, Vascular calcification, Endothelial Dysfunction
- Medical subject headings
- Renal Insufficiency, Chronic, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevelamer carbonateDrug
Also called Renvela
Sevelamer carbonate 1,600 mg three times daily with meals
Calcium acetateDrug
Also called Phoslo
Calcium acetate 1,334 mg three times daily with meals for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sevelamer carbonate | Experimental | 1,600 mg (2 x 800 mg) three times daily with meals for a total of 12 weeks Receives: Drug: Sevelamer carbonate |
| Calcium acetate | Active comparator | 1,334 mg (2 x 667 mg) three times daily with meals for a total of 12 weeks Receives: Drug: Calcium acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the change in FGF-23 concentrations
Measured: 12 weeks
Secondary outcomes (3)
Change in vascular calcification biomarker levels
Measured: 12 weeks
Change in endothelial dysfunction biomarker levels.
Measured: 12 Weeks
Change in inflammatory biomarker levels
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2016
- Study completionMar 2016 (estimated)
Why it stopped: low enrollment
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 DiseaseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany College of Pharmacy and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Albany Medical College, Genzyme, a Sanofi Company
- Responsible party
- Principal investigator, Darius Mason, Albany College of Pharmacy and Health Sciences
- Investigators
- Darius L Mason, Pharm.D., Principal investigator, Albany College of Pharmacy and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277497
- Sponsor's protocol ID
- 2902
- Status last verified
- Jan 2016
- First submitted
- 6 Jan 2011
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mason DL, Godugu K, Nnani D, Mousa SA. Effects of sevelamer carbonate versus calcium acetate on vascular calcification, inflammation, and endothelial dysfunction in chronic kidney disease. Clin Transl Sci. 2022 Feb;15(2):353-360. doi: 10.1111/cts.13151. Epub 2021 Oct 2.
PubMed 34599865
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study on the Effects of Sevelamer Carbonate Versus Calcium Acetate on Biomarkers of Vascular Calcification, Inflammation, and Endothelial Dysfunction in Chronic Kidney Disease Stages 3 and 4
- ClinicalTrials.gov ID
- NCT01277497
- Acronym / sponsor ID
- 2902
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic kidney disease, Phosphate binder, Sevelamer carbonate, Calcium acetate, Vascular calcification, Endothelial Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Albany College of Pharmacy and Health SciencesUniversity, hospital or other
- Collaborators
- Albany Medical College, Genzyme, a Sanofi Company
- Study start
- Jan 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (estimated)
- First posted
- 17 Jan 2011 (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.
Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and as a result phosphorus accumulates in the blood. In response to elevated phosphorus levels, more FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine. In addition to effects on FGF-23, increased phosphorus levels can lead to calcification (hardening) of the blood vessels in the CKD population.
Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD, studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering FGF-23 levels in CKD patients may also lower substances in the blood that cause calcification of blood vessels in the CKD population.
This study is being done to determine if using phosphate binders, either sevelamer carbonate or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood vessels and heart disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevelamer carbonate | Experimental | Drug: Sevelamer carbonate1,600 mg (2 x 800 mg) three times daily with meals for a total of 12 weeks |
| Calcium acetate | Active comparator | Drug: Calcium acetate1,334 mg (2 x 667 mg) three times daily with meals for a total of 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females ≥ 18 years of age at start of screening
- CKD stage 3 or 4 defined by an eGFR 15 - 60 mL/min/1.73m2
- Not expected to start dialysis for 8 months
- Serum intact PTH < 500 pg/mL during screening period
- On a stable ACE inhibitor/ARB regimen for 30 days prior to screening
Key exclusion criteria (9 listed)
- History of any of the following diseases: congestive heart failure, MI within the last 6 months, cerebrovascular accident, significant valvular disease, malignancy
- Currently receiving erythropoiesis stimulating agent or IV iron therapy
- History of inflammatory/autoimmune disease
- History of polycystic kidney disease
- HIV positive or AIDS
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: RenvelaSevelamer carbonate 1,600 mg three times daily with meals | Drug | Sevelamer carbonate |
| Calcium acetateAlso: PhosloCalcium acetate 1,334 mg three times daily with meals for 12 weeks | Drug | Calcium acetate |
Primary outcome
The primary outcome measure will be the change in FGF-23 concentrations
Time frame: 12 weeks
3 secondary outcomes
Change in vascular calcification biomarker levels
Time frame: 12 weeks
Change in endothelial dysfunction biomarker levels.
Time frame: 12 Weeks
Change in inflammatory biomarker levels
Time frame: 12 Weeks
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Derived from this study: PubMed 34599865Mason DL, Godugu K, Nnani D, Mousa SA. Effects of sevelamer carbonate versus calcium acetate on vascular calcification, inflammation, and endothelial dysfunction in chronic kidney disease. Clin Transl Sci. 2022 Feb;15(2):353-360. doi: 10.1111/cts.13151. Epub 2021 Oct 2.
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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.
Darius L Mason, Pharm.D. principal investigator
Albany College of Pharmacy and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevelamer carbonate and Calcium acetate in people with Chronic Kidney Disease, run by Albany College of Pharmacy and Health Sciences at 1 site in United States.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Jan 2016. 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 States. 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. 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 was stopped early (reason given: low enrollment). Results are not available in the source record.
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?
The primary outcome measure will be the change in FGF-23 concentrations (time frame: 12 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 NCT01277497, 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 14 Jan 2016.