Trial · NCT01427907
Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
NCT01427907, Phase 4, Completed, Fresenius Medical Care North America; results first posted 2016-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients. Trials, record NCT01427907. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01427907
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Equivalence of Calcium Acetate Oral Solution and Sevelamer Carbonate Tablets in Hemodialysis Patients
- NCT number
- NCT01427907
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 38 participants, actual
- Lead sponsor
- Fresenius Medical Care North America
- Conditions
- Chronic Kidney Disease
- Interventions
- Calcium acetate oral solution (COS), Sevelamer carbonate
- First posted
- 2011-09-02
- Last updated
- 2016-01-14
- Results first posted
- 2016-01-14
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Phosphorus Levels | 2 weeks | The average phosphorus level of non-missing laboratory assessments from the last two weeks of each treatment period for each subject |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serum Phosphorus Levels | 2 weeks | 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 | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serum Phosphorus Levels | Calcium Acetate Oral Solution | 4.6 | Standard Deviation 1.20 | mg/dL | |
| Serum Phosphorus Levels | Sevelamer Carbonate | 4.6 | Standard Deviation 0.93 | mg/dL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks) | 20 | |
| Overall Study | STARTED | Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks) | 18 | |
| Overall Study | COMPLETED | Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks) | 17 | |
| Overall Study | COMPLETED | Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks) | 14 | |
| Overall Study | NOT COMPLETED | Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks) | 3 | |
| Overall Study | NOT COMPLETED | Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks) | 4 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | hematemesis | Renal and urinary disorders | Calcium Acetate Oral Solution | 1 | 38 | 1 |
| other | hematemesis | Renal and urinary disorders | Sevelamer Carbonate | 0 | 38 | 0 |
| other | squamous cell carcinoma removed | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Calcium Acetate Oral Solution | 1 | 38 | 1 |
| other | squamous cell carcinoma removed | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Sevelamer Carbonate | 0 | 38 | 0 |
| other | hypercalcimia | Metabolism and nutrition disorders | Calcium Acetate Oral Solution | 3 | 38 | 3 |
| other | hypercalcimia | Metabolism and nutrition disorders | Sevelamer Carbonate | 0 | 38 | 0 |
| other | hyperphosphatemia | Metabolism and nutrition disorders | Calcium Acetate Oral Solution | 1 | 38 | 1 |
| other | hyperphosphatemia | Metabolism and nutrition disorders | Sevelamer Carbonate | 0 | 38 | 0 |
| other | left uper quadrant discomfort | Musculoskeletal and connective tissue disorders | Calcium Acetate Oral Solution | 1 | 38 | 1 |
| other | left uper quadrant discomfort | Musculoskeletal and connective tissue disorders | Sevelamer Carbonate | 0 | 38 | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Calcium Acetate Oral Solution | ||
| Total, all-cause mortality | Sevelamer Carbonate | ||
| Total, other adverse events | Calcium Acetate Oral Solution | 13 | 38 |
| Total, other adverse events | Sevelamer Carbonate | 6 | 38 |
| Total, serious adverse events | Calcium Acetate Oral Solution | 2 | 38 |
| Total, serious adverse events | Sevelamer Carbonate | 1 | 38 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40576086 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Calcium Acetate Oral Solution vs Sevelamer Carbonate: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01427907
GET https://conductscience.org/api/trials/v1/NCT01427907/events?page=2