Chronic Kidney DiseasePhase 4COS-002NCT01427907

Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients

A Phase 4 study testing Calcium acetate oral solution (COS) and Sevelamer carbonate in people with Chronic Kidney Disease, run by Fresenius Medical Care North America at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the equivalence of a liquid formulation of a calcium-based phosphate binder, COS… 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?: Calcium acetate oral solution (COS) and Sevelamer carbonate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 4 sitesUnited States
Study dates: Sep 2011to Jul 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male or female subjects ≥18 years of age able to give written informed consent to the study
Hemodialysis dependent chronic kidney disease stage 5D patients
Taking sevelamer carbonate tablets or sevelamer hydrochloride as phosphate binder monotherapy
Taking 3 or more sevelamer carbonate or sevelamer hydrochloride tablets per day

Who cannot join

Estimated life expectancy of less than 6 months and for cancer patients, an Eastern Cooperative Oncology Group (ECOG) Performance Status >1
Active malignancy within the past 5 years. Basal or squamous cell skin cancer is not exclusionary. History of malignancy is not an exclusion
Known hypersensitivity reaction to calcium-based phosphate binders
Anticipated renal transplantation during the study
Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

St. Raphael's Dialysis Center
New Haven, Connecticut, 06511
Irving Place Dialysis Center
New York, New York, 10003
Upper Manhattan Dialysis Clinic (UMDC)
New York, New York, 10025
North Haven Dialysis
North Haven, Connecticut, 06473

Other trials in United States

About this study

Official title: Randomized,Multi-center,Phase IV, 2-arm,Open-Label,Cross-over Study to Demonstrate the Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients

The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels

This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the equivalence of a liquid formulation of a calcium-based phosphate binder, COS, to sevelamer carbonate tablets, in hemodialysis dependent Chronic Kidney Disease subjects (CKD). The aim of the study is to maintain serum phosphorus level and establish equivalence between COS and sevelamer carbonate tablets.

Read the detailed description

Total 40 subjects will be randomized for participation into the study The subjects are Hemo-dialysis Dependent Chronic Kidney Disease (CKD) Stage 5D patients who are able to give informed consent to the study, and taking the phosphate binder sevelamer carbonate tablets.

Conditions: Chronic Kidney Disease
Being tested: Calcium acetate oral solution (COS), Sevelamer carbonate
Keywords: Serum phosphorus levels
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Calcium acetate oral solution (COS)Drug
Also called Phoslyra
Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).
Sevelamer carbonateDrug
Also called Renvela
Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).

Study groups in NCT01427907
Study group	Role	What they receive
Phoslyra - Calcium Acetate Oral Solution	Experimental	The investigational compound is calcium acetate oral solution (COS) or Phoslyra. It is a pale, light greenish-yellow clear liquid with a characteristic black cherry odor and flavor for oral ingestion. Each 5 mL of COS contains 667 mg calcium acetate equal to 169 mg of elemental calcium. Each subject will follow their usual prescription.COS will be taken either prior to or during meals and snacks. Receives: Drug: Calcium acetate oral solution (COS)
Sevelamer Carbonate	Active comparator	Sevelamer carbonate is an anion exchange resin that binds phosphate in the gastrointestinal tract and is a buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphatemia in End-Stage Renal Disease (ESRD) patients. Each film-coated tablet of sevelamer carbonate (trade name Renvela™) contains 800 mg of sevelamer carbonate on an anhydrous basis. Subjects will receive sevelamer tablets according to their prescription. Receives: Drug: Sevelamer carbonate

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Phosphorus Levels
The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Jul 2012

First posted2 Sep 2011 (estimated)
Study startSep 2011
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01427907
Sponsor's protocol ID: COS-002
Acronym: COS-002
Status last verified: Dec 2015
First submitted: 31 Aug 2011
Last updated: 14 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
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 40576086

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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: Randomized,Multi-center,Phase IV, 2-arm,Open-Label,Cross-over Study to Demonstrate the Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
ClinicalTrials.gov ID: NCT01427907
Acronym / sponsor ID: COS-002 / COS-002
Conditions: Chronic Kidney Disease
Keywords: Serum phosphorus levels
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 2 Sep 2011 (estimated)
Results: Posted 14 Jan 2016

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 demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Phoslyra - Calcium Acetate Oral Solution	Experimental	Drug: Calcium acetate oral solution (COS)The investigational compound is calcium acetate oral solution (COS) or Phoslyra. It is a pale, light greenish-yellow clear liquid with a characteristic black cherry odor and flavor for oral ingestion. Each 5 mL of COS contains 667 mg calcium acetate equal to 169 mg of elemental calcium. Each subject will follow their usual prescription.COS will be taken either prior to or during meals and snacks.
Sevelamer Carbonate	Active comparator	Drug: Sevelamer carbonateSevelamer carbonate is an anion exchange resin that binds phosphate in the gastrointestinal tract and is a buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphatemia in End-Stage Renal Disease (ESRD) patients. Each film-coated tablet of sevelamer carbonate (trade name Renvela™) contains 800 mg of sevelamer carbonate on an anhydrous basis. Subjects will receive sevelamer tablets according to their prescription.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female subjects ≥18 years of age able to give written informed consent to the study
Hemodialysis dependent chronic kidney disease stage 5D patients
Taking sevelamer carbonate tablets or sevelamer hydrochloride as phosphate binder monotherapy
Taking 3 or more sevelamer carbonate or sevelamer hydrochloride tablets per day

Key exclusion criteria (5 listed)

Estimated life expectancy of less than 6 months and for cancer patients, an Eastern Cooperative Oncology Group (ECOG) Performance Status >1
Active malignancy within the past 5 years. Basal or squamous cell skin cancer is not exclusionary. History of malignancy is not an exclusion
Known hypersensitivity reaction to calcium-based phosphate binders
Anticipated renal transplantation during the study
Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception.

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
Calcium acetate oral solution (COS)Also: PhoslyraEach subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).	Drug	Phoslyra - Calcium Acetate Oral Solution
Sevelamer carbonateAlso: RenvelaEach subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).	Drug	Sevelamer Carbonate

Primary outcome

Serum Phosphorus Levels
Time frame: 2 weeks
The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject

Results and safety

Results posted to the registry on 14 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks)	20	17
Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks)	18	14

Primary outcome: Serum Phosphorus Levels

Time frame: 2 weeks. Mean (Standard Deviation). Unit: mg/dL

Measure	Calcium Acetate Oral Solution n = 32	Sevelamer Carbonate n = 32
Value	4.6 (1.20)	4.6 (0.93)

Population analysed: Modified intent-to-treat: subjects who were randomized, received at least one prescribed dose of the study medication and provided at least one of the last 4 laboratory assessments of each treatment period

Adverse events

Time frame: 6 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Calcium Acetate Oral Solution	2 of 38 (5.3%)	13 of 38 (34.2%)	Not reported
Sevelamer Carbonate	1 of 38 (2.6%)	6 of 38 (15.8%)	Not reported

Limitations and caveats (from the sponsor): The Last Patient Last Visit (LPLV) was on 06-July-2012 and last site close out visit was 31 May 2013. Due to inadvertent study deviations, no reliable conclusions can be drawn from the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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RecruitingPhase 3
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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.

Peter Katanko, MD principal investigator

Renal Research Institute

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Calcium acetate oral solution (COS) and Sevelamer carbonate in people with Chronic Kidney Disease, run by Fresenius Medical Care North America at 4 sites 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 4 inclusion and 5 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 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 4 sites 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?

Yes. Results are posted in the registry (first posted 14 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Serum Phosphorus Levels (time frame: 2 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 NCT01427907, 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.