Trial · NCT01850602
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
NCT01850602, Phase 3, Completed, Kissei Pharmaceutical Co., Ltd.; results first posted 2018-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia. Trials, record NCT01850602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01850602
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
- NCT number
- NCT01850602
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 213 participants, actual
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Conditions
- Hemodialysis, Hyperphosphatemia
- Interventions
- PA21, Sevelamer hydrochloride
- First posted
- 2013-05-09
- Last updated
- 2018-10-09
- Results first posted
- 2018-10-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment | 12 weeks | Covariate: Serum phosphorus concentrations at baseline. |
| Secondary | Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | 12 weeks | |
| Secondary | Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | 12 weeks | |
| Secondary | Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | 12 weeks |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment | 12 weeks | Per Protocol Set | mg/dL | MEAN |
| SECONDARY | Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | 12 weeks | Per Protocol Set | mg/dL | MEAN |
| SECONDARY | Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | 12 weeks | Per Protocol Set | mg/dL | MEAN |
| SECONDARY | Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | 12 weeks | Per Protocol Set | pg/mL | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment | PA21 | 5.00 | 95% Confidence Interval 4.80 to 5.19 | mg/dL | |
| Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment | Sevelamer Hydrochloride | 5.34 | 95% Confidence Interval 5.13 to 5.55 | mg/dL | |
| Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | PA21 | 5.01 | Standard Deviation 1.01 | mg/dL | |
| Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) | Sevelamer Hydrochloride | 5.33 | Standard Deviation 1.03 | mg/dL | |
| Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | PA21 | 9.14 | Standard Deviation 0.68 | mg/dL | |
| Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) | Sevelamer Hydrochloride | 8.91 | Standard Deviation 0.71 | mg/dL | |
| Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | PA21 | 203.6 | Standard Deviation 117.1 | pg/mL | |
| Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) | Sevelamer Hydrochloride | 253.1 | Standard Deviation 168.6 | pg/mL |
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 | PA21 | 108 | |
| Overall Study | STARTED | Sevelamer Hydrochloride | 105 | |
| Overall Study | COMPLETED | PA21 | 94 | |
| Overall Study | COMPLETED | Sevelamer Hydrochloride | 87 | |
| Overall Study | NOT COMPLETED | PA21 | 14 | |
| Overall Study | NOT COMPLETED | Sevelamer Hydrochloride | 18 |
Source ClinicalTrials.gov
Adverse events30
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 | Nasopharyngitis | Infections and infestations | PA21 | 24 | 108 | |
| other | Nasopharyngitis | Infections and infestations | Sevelamer Hydrochloride | 24 | 105 | |
| other | Constipation | Gastrointestinal disorders | PA21 | 2 | 108 | |
| other | Constipation | Gastrointestinal disorders | Sevelamer Hydrochloride | 19 | 105 | |
| other | Diarrhoea | Gastrointestinal disorders | PA21 | 27 | 108 | |
| other | Diarrhoea | Gastrointestinal disorders | Sevelamer Hydrochloride | 3 | 105 | |
| serious | Diverticulitis | Infections and infestations | PA21 | 0 | 108 | |
| serious | Diverticulitis | Infections and infestations | Sevelamer Hydrochloride | 1 | 105 | |
| serious | Pneumonia | Infections and infestations | PA21 | 1 | 108 | |
| serious | Pneumonia | Infections and infestations | Sevelamer Hydrochloride | 0 | 105 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PA21 | 0 | 108 |
| Total, all-cause mortality | Sevelamer Hydrochloride | 0 | 105 |
| Total, other adverse events | PA21 | 47 | 108 |
| Total, other adverse events | Sevelamer Hydrochloride | 42 | 105 |
| Total, serious adverse events | PA21 | 6 | 108 |
| Total, serious adverse events | Sevelamer Hydrochloride | 5 | 105 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PA21 vs Sevelamer Hydrochloride: deaths from any cause | Trial comparisons |
| PA21 vs Sevelamer Hydrochloride: serious adverse events | 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/NCT01850602
GET https://conductscience.org/api/trials/v1/NCT01850602/events?page=2