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PA21

Phase 3

Chronic Kidney Disease Requiring Chronic Dialysis | Small molecule | Nephrology |Fresenius Medical Care AG|Last Updated: Jun 2, 2021

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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment2,004
FDA Designations
No designations recorded
Clinical trial landscape

PA21 · 3 trials · 2 indications

Phase 3 3
NCT01464190A Phase 3 Extension Study to Investigate the Long-term Safety, Tolerability and Efficacy of PA21, a Phosphate Binder in Dialysis PatientsChronic Kidney Disease Requiring Chronic Dialysis
COMPLETED659 Analytics
NCT01324128A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis PatientsChronic Kidney Disease Requiring Chronic Dialysis
COMPLETED1,059 Analytics
NCT03644264PA21 Safety and Efficacy in Adult Chinese SubjectsChronic Kidney Disease Requiring Chronic Dialysis
COMPLETED286 Analytics
PHASE3COMPLETED
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
NCT01464190659
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PHASE3COMPLETED
A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients
Chronic Kidney Disease Requiring Chronic Dialysis
NCT013241281,059
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PHASE3COMPLETED
PA21 Safety and Efficacy in Adult Chinese Subjects
Chronic Kidney Disease Requiring Chronic Dialysis
NCT03644264286
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Study Endpoints
Primary Endpoints
Change From Baseline and Levels at Each Time Point for Serum Phosphorus
Every 4 weeks from baseline to Week 28

Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.

Change From Baseline and Levels at Each Time Point for Serum Calcium
Every 4 weeks from baseline to Week 28

Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.

Change From Baseline and Levels at Each Time Point for Serum Intact Parathyroid Hormone (iPTH)
Every 4 weeks from baseline to Week 28

Endpoint is Week 28 or the latest available measurement after baseline when Week 28 data is missing.

Change in Serum Phosphorus Levels From Week 24 to Week 27
Week 24, Week 27

Change in serum phosphorus levels compared between PA21 Maintenance Dose (MD) and PA21-1 Low Dose (LD) in Stage 2 from Week 24 to Week 27

Serum phosphorus (mmol/l )
baseline and 12 weeks

Change from baseline in serum phosphorus levels at Week 12: comparison between PA21 group and sevelamer carbonate group.

Secondary Endpoints
Change in Serum Phosphorus Levels From Baseline to Week 12
Week 12 post Baseline
Serum phosphorus (mmol/l )
baseline, weeks 1, 2, 4, 6, 8, 12
Serum phosphorus (mmol/l)
baseline, weeks 1, 2, 4, 6, 8, 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PA21EXPERIMENTAL -
Sevelamer carbonateACTIVE_COMPARATOR -
PA21 (2.5 g tablet)EXPERIMENTAL -
PA21-1 (1.25 g tablet)OTHER -
PA21 tablets containing 500 mg of ironEXPERIMENTALPA21 chewable tablets standardised to contain 500 mg of iron. PA21 500 mg (iron) chewable tablet contains approximately 2.5 g PA21 drug substance (sucroferric oxyhydroxide). Starting dose will be 1,500 mg/day (3 tablets/day (1 tablet per meal)). Dose increases or decreases of 500 mg/day (1 tablet/day) are permitted. The maximum dose of PA21 will be 3,000 mg/day (6 x 500 mg tablets/day) and the minimum dose will be 1,000 mg/day (2 x 500 mg tablets/day).
Sevelamer carbonate: Renvela® tabletsACTIVE_COMPARATORStarting dose will be 2.4 g/day (3 tablets/day). Dose increases or decreases of 2.4 g/day (3 tablets/day (1 tablet per meal)) The maximum dose of sevelamer carbonate will be 14.4 g/day (18 tablets/day) and the minimum dose will be 2.4 g/day (3 tablets/day).
Interventions
NameTypeDescription
PA21 (2.5 g tablet containing 500 mg iron)DRUGDose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
Sevelamer carbonateDRUGFilm coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
PA21-1 (1.25 g tablet containing 250 mg iron)DRUGLow dose comparator (1.25 g/day)
PA21DRUGsucroferric oxyhydroxide is a mixture of polynuclear iron(III)-oxyhydroxide (about 33% m/m), sucrose (about 30% m/m), and starches (about 28% m/m) and contains ≤10% m/m water.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

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

Countries:United StatesAustriaBelgiumCroatiaCzechiaGermanyLatviaLithuaniaPolandRomaniaRussiaSerbiaSouth AfricaUkraineUnited KingdomChina
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