Phase 3
Completed N=35
A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
Hemodialysis · Hyperphosphatemia
Source: ClinicalTrials.gov NCT01850641 ↗
Enrolled (actual)
35
Serious AEs
2.9%
Results posted
Oct 2018
Primary outcomePrimary: Incidence of Adverse Events — 28 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to investigate the safety and efficacy when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
28 | — |
| SECONDARY Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value) |
4.89 | — |
| SECONDARY Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value) |
9.52 | — |
| SECONDARY Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value) |
177.9 | — |
| SECONDARY Serum Ferritin Concentrations at End of Treatment (Actual Measured Value) |
73.8 | — |
| SECONDARY TSAT at End of Treatment (Actual Measured Value) |
27.72 | — |
| SECONDARY Hb Concentrations at End of Treatment (Actual Measured Value) |
11.22 | — |
| SECONDARY Constipation Condition |
15; 14; 2; 4; 0; 26 | — |
| SECONDARY Satisfaction With Bowel Movement |
21; 8; 6; 28; 5; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Receiving stable maintenance hemodialysis 3 times a week
- Dialysis patients with hyperphosphatemia
Exclusion Criteria
- Patients having history of a pronounced brain / cardiovascular disorder
- Patients having severe gastrointestinal disorders
- Patients having severe hepatic disorders
Data sourced from ClinicalTrials.gov (NCT01850641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.