A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
R1 Therapeutics
Study ID
NCT06712654
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Kidney Disease Requiring Chronic Dialysis
  • End Stage Renal Disease on Dialysis
  • Hyperphosphatemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AP306 75 mg BID — DRUG
    AP306 75 mg by mouth, twice daily (150 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
  • AP306 125 mg BID — DRUG
    AP306 125 mg by mouth, twice daily (250 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
  • AP306 150 mg BID — DRUG
    AP306 150 mg by mouth, twice daily (300 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
  • AP306 75 mg TID — DRUG
    AP306 75 mg by mouth, three times daily (225 mg/day). Treatment given daily for 8 weeks.
  • AP306 100 mg TID — DRUG
    AP306 100 mg by mouth, three times daily (300 mg/day). Treatment given daily for 8 weeks.
  • AP306 125 mg TID — DRUG
    AP306 125 mg by mouth, three times daily (375 mg/day). Treatment given daily for 8 weeks.
  • Placebo — DRUG
    Placebo given by mouth, three times daily. Treatment given daily for 8 weeks.

Study Details

This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
  • Experimental: Cohort 2
  • Experimental: Cohort 3
  • Experimental: Cohort 4
  • Experimental: Cohort 5
  • Experimental: Cohort 6
  • Placebo Comparator: Cohort 7

Primary Outcome Measure

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

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Apogee Clinical Research, LLCHuntsvilleAlabama35801-
California Institute of Renal ResearchChula VistaCalifornia91910-
Academic Medical Research InstituteLos AngelesCalifornia90022-
Colorado Kidney CareDenverColorado80220-
DaVita Clinical ResearchMiddleburyConnecticut06762-
US Renal CareOrangeConnecticut06477-
US Renal CareFort MyersFlorida33912-
US Renal CareDaltonGeorgia30720-
St. Clair Nephrology ResearchShelbyMichigan48315-
Johnson County Clinical TrialsKansas CityMissouri64111-
DaVita Clinical ResearchLas VegasNevada89107-
Renal Medicines AssociatesAlbuquerqueNew Mexico87109-
US Renal CareToledoOhio43613-
Sunbeam ResearchGreenvilleTexas75402-
DaVita Clinical ResearchHoustonTexas77054-
Gamma Medical ResearchMcAllenTexas78503-
DaVita Clinical ResearchSan AntonioTexas78258-
US Renal CareSan AntonioTexas78251-
DaVita Clinical ResearchNorfolkVirginia23502-

Find similar trials in Huntsville, AL

By research site
Apogee Clinical Research, LLC· Huntsville, ALCalifornia Institute of Renal Research· Chula Vista, CAAcademic Medical Research Institute· Los Angeles, CAColorado Kidney Care· Denver, CODaVita Clinical Research· Middlebury, CTUS Renal Care· Orange, CT

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