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AP306

Phase 2

Hyperphosphatemia | Small molecule | Nephrology |cbdMD, Inc.|Last Updated: Aug 26, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment168

FDA Designations

No designations recorded

Clinical trial landscape

AP306 · 1 trial · 3 indications

Phase 2 1
NCT06712654A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With HyperphosphatemiaHyperphosphatemia
RECRUITING168 Analytics
PHASE2RECRUITING
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Hyperphosphatemia
NCT06712654168
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Study Endpoints

Primary Endpoints

To investigate the ability of AP306 at different fixed doses to lower serum phosphate in participants with hyperphosphatemia receiving maintenance hemodialysis
8 weeks

The change in serum phosphate from baseline to the end of treatment or before the initiation of rescue therapy, or before the interruption of study drug due to serum phosphate \<2.5 mg/dL (0.81 mmol/L)

Secondary Endpoints

To assess the proportion of participants with serum phosphate in the target range
8 weeks
To assess the change in serum phosphate from baseline to the end of the Treatment Period
8 weeks
To assess the time to response on serum phosphate reduction
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Cohort 4EXPERIMENTAL -
Cohort 5EXPERIMENTAL -
Cohort 6EXPERIMENTAL -
Cohort 7PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AP306 75 mg BIDDRUGAP306 75 mg by mouth, twice daily (150 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 125 mg BIDDRUGAP306 125 mg by mouth, twice daily (250 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 150 mg BIDDRUGAP306 150 mg by mouth, twice daily (300 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
AP306 75 mg TIDDRUGAP306 75 mg by mouth, three times daily (225 mg/day). Treatment given daily for 8 weeks.
AP306 100 mg TIDDRUGAP306 100 mg by mouth, three times daily (300 mg/day). Treatment given daily for 8 weeks.
AP306 125 mg TIDDRUGAP306 125 mg by mouth, three times daily (375 mg/day). Treatment given daily for 8 weeks.
PlaceboDRUGPlacebo given by mouth, three times daily. Treatment given daily for 8 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

Important Inclusion Criteria: * Signs a written informed consent form (ICF) and is willing to comply with all study requirements in the study * Receiving a stable hemodialysis (including hemodialysis, hemodiafiltration, and hemoadsorption) regimen, which is defined as a frequency of three times per...

Countries:United StatesChina
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