CompletedPhase 3

AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia

China474 participantsStarted 2023-06-12

Plain-language summary

This Phase 3 clinical trial is the pivotal study of AP301 aiming to evaluate the efficacy and safety of AP301 for controlling serum phosphorus in chronic kidney disease receiving hemodialysis and peritoneal dialysis in Chinese patients with hyperphosphatemia.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL)
✓. After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)
✓. Screening: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)

What they're measuring

Change in serum phosphorus levels between AP301 and AP301 low dose groups in hyperphosphatemic patients

Timeframe: From the end of Week 24 to the end of Week 27

Change in serum phosphorus levels between AP301 and sevelamer carbonate groups in hyperphosphatemic patients

Timeframe: From Baseline to the end of Week 12

Trial details

NCT IDNCT07030595

SponsorAlebund Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-02

View on ClinicalTrials.gov More ESRD (End Stage Renal Disease) trials