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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium acetate oral solution (COS) | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Phosphorus Levels | The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Katanko, MD | Renal Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Raphael's Dialysis Center | New Haven | Connecticut | 06511 | United States | ||
| North Haven Dialysis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | 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. |
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A total of 44 subjects signed the informed consent form (ICF), 5 subjects were not eligible, and 1 eligible subject withdrew the ICF prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks) | Patient receive Calcium Acetate Oral Solution (COS) for 4 weeks then cross over to Sevelamer tablets for 4 weeks. |
| FG001 | Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sevelamer carbonate | Drug | 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). |
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| North Haven |
| Connecticut |
| 06473 |
| United States |
| Irving Place Dialysis Center | New York | New York | 10003 | United States |
| Upper Manhattan Dialysis Clinic (UMDC) | New York | New York | 10025 | United States |
Patient receive Sevelamer tablets for 4 weeks, then cross over to take COS for 4 weeks.
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence I: COS Then Sevelamer | Sequence I: Calcium Acetate Oral Solution for 4 weeks then Sevelamer Carbonate for 4 weeks |
| BG001 | Sequence II: Sevelamer Then COS | Sevelamer Carbonate for 4 weeks then Calcium Acetate Oral Solution for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Phosphorus Levels | The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject | 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 | Posted | Mean | Standard Deviation | mg/dL | 2 weeks |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium Acetate Oral Solution | Sequence I: Calcium Acetate Oral Solution for periods 1 and 2 | 2 | 38 | 13 | 38 | ||
| EG001 | Sevelamer Carbonate | Sevelamer Carbonate for periods 1 and 2 | 1 | 38 | 6 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| hospitalization | Skin and subcutaneous tissue disorders | Non-systematic Assessment | due to cellulitis to both legs |
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| Bacteremia; cellulitis, fever | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hematemesis | Renal and urinary disorders | Non-systematic Assessment |
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| squamous cell carcinoma removed | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| hypercalcimia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| hyperphosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| left uper quadrant discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| flatulence | Gastrointestinal disorders | Non-systematic Assessment |
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| emesis | Gastrointestinal disorders | Non-systematic Assessment |
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| arm pain | General disorders | Non-systematic Assessment |
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| sharp stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
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| strong acid reflux | Gastrointestinal disorders | Non-systematic Assessment |
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| chest pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| cramping | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| hypertension | Vascular disorders | Non-systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mayuri Thakuria MD (MBBS), MPH | Fresenius Medical Care, North America | 781-699-4645 | mayuri.thakuria@fmc-na.com |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C120662 | calcium acetate |
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| >=65 years |
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| Male |
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