Phase 3
N=659
A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis Patients
Chronic Kidney Disease Requiring Chronic Dialysis
Bottom Line
View on ClinicalTrials.gov: NCT01464190 ↗Enrolled (actual)
659
Serious AEs
19.8%
Results posted
Feb 2014
Primary outcome: Primary: Change From Baseline and Levels at Each Time Point for Serum Phosphorus — -0.2; -0.1; -0.2; 0.1 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PA21 (2.5 g tablet containing 500 mg iron) (Drug); Sevelamer carbonate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vifor Pharma
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline and Levels at Each Time Point for Serum Phosphorus |
-0.2; -0.1; -0.2; 0.1; -0.0; 0.2 | — |
| PRIMARY Change From Baseline and Levels at Each Time Point for Serum Calcium |
-1.2; -0.8; -1.2; 1.5; 0.1; 1.9 | — |
| PRIMARY Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH) |
11.8; 25.9; 8.6; 40.8; 28.9; 64.1 | — |
Summary
This is a Phase 3, randomised, active controlled, multicentre extension study to investigate the long-term safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. This is an extension study to PA-CL-05A (NCT01324128), subjects have already been enrolled and have been treated with study medication for at least 24 weeks.
Eligibility Criteria
Inclusion Criteria
- Subjects who have completed treatment in Protocol PA-CL-05A
- Written Informed Consent
Exclusion Criteria
- Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
- Other significant medical conditions
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01464190). 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.