Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06933472 · ClinicalTrials.gov registry record · Phase 3
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
A Phase 3 study of Hyperphosphatemia and Dialysis, sponsored by Alebund Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 264
- Enrollment target
- 20
- Study locations
NCT06933472: Recruiting Phase 3 study of Hyperphosphatemia and Dialysis, sponsored by Alebund Pharmaceuticals.
NCT06933472 is a Phase 3 study of Hyperphosphatemia and Dialysis that is actively recruiting participants, run by Alebund Pharmaceuticals. The registered enrollment target is 264 participants, below the 826-participant average among 8 other Hyperphosphatemia trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06933472, a Phase 3 study of Hyperphosphatemia and Dialysis, is actively recruiting participants, sponsored by Alebund Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 264 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are: * Does AP301 lower blood phosphate levels? * Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level? * What discomfort or medical problem do the patients have when taking AP301? * Does AP301 improve quality of life in Chinese patients? The researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate. In the study, the patients will experience the following stages in a chronicle order: * Stop all using blood phosphate-lowering drugs, * Take AP301 or the comparator three times a day for 8 weeks, * Take AP301 three times a day for 24 weeks, and * Take AP301 or the comparator three times a day for 3 weeks. In the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment. If the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.
Primary Outcome
The amount of phosphate in the blood will be measured with a standard laboratory test. The change in phosphate levels will be compared between the group receiving AP301 and the group receiving AP301 low dose.
Conditions Studied
Interventions
- DRUG AP301
- DRUG AP301 Low Dose
Study Locations (20)
Texas
- Dallas Renal Group - Dallas - Dallas
- US Renal Care - Bluebonnet - Fort Worth
- Gamma Medical Research - McAllen
- US Renal Care - South San Antonio - San Antonio
- US Renal Care - Hill Country - San Antonio
California
- Renal Consultants Medical Group - Granada Hills
- North America Research Institute - San Dimas - San Dimas
- North America Research Institute - San Dimas - San Dimas
Mississippi
- Nephrology Associates, P.C. - Columbus - Columbus
- Nephrology & Hypertension Associates Ltd - Tupelo - Tupelo
New York
- US Renal Care - West Cheektowaga - Cheektowaga
- NY Kidney & Hypertension Medicine - Ridgewood
Colorado
- Rocky Mountain Kidney Care - Lone Tree - Lone Tree
Connecticut
- PACT Kidney Care - Orange - Orange
Florida
- US Renal Care - Fort Myers South - Fort Myers
Georgia
- Nephrology & Hypertension Specialists - Dalton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2025-06-13 |
| Est. Completion | 2027-01-10 |
| Phase | Phase 3 |
What NCT06933472 shows while recruiting
NCT06933472 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, below the 826-participant average among 8 other Hyperphosphatemia trials with a reported enrollment target (68% lower).
The record links to 4 conditions, with Hyperphosphatemia appearing as the primary indexed condition, and to 2 interventions - of which AP301 is the first listed.
NCT06933472 names 20 study sites across 12 states, led by Texas, California, Mississippi.
Frequently Asked Questions
What is clinical trial NCT06933472 about?
NCT06933472 is a clinical study titled "A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China". The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are: * Does AP301 lower blood phosphate levels? * Does AP301 works on serum calcium level, calcium times phosphate level...
What is the current status of trial NCT06933472?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 264 participants. The study started on 2025-06-13. Estimated completion is 2027-01-10.
What conditions does trial NCT06933472 study?
This clinical trial studies the following conditions: Hyperphosphatemia, Dialysis, ESRD (End-Stage Renal Disease), Chronic Kidney Disease, Receiving Dialysis.
What interventions are being tested in trial NCT06933472?
The interventions under investigation include: AP301 (DRUG), AP301 Low Dose (DRUG).
Who is sponsoring clinical trial NCT06933472?
This trial is sponsored by Alebund Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06933472 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hyperphosphatemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06933472's enrollment target sits among peer trials
264 4th of 8 higher than 5 of 8 other Hyperphosphatemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperphosphatemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Ferric Citrate for the Transition From CKD Stage 4/5 to CKD Stage 5D
COMPLETED · Phase 3
-
A 58-Week Safety and Efficacy Trial of Ferric Citrate in Patients With ESRD on Dialysis
COMPLETED · Phase 3
-
Ferric Citrate for the Prevention of Renal Failure in Adults With Advanced Chronic Kidney Disease
COMPLETED · Phase 3
-
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
RECRUITING
-
A Long-Term Study of Tenapanor Alone or in Combination With Sevelamer in Patients With CKD on Dialysis and HP
COMPLETED · Phase 4
-
Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04101669 · 264 participants · NA
RESET System Pivotal Trial (Rev F)
- NCT04295863 · 264 participants · Phase 1
Comparing Dosing Intervals of Nivolumab or Pembrolizumab in Locally Advanced or Metastatic Cancers
- NCT05220202 · 264 participants · NA
MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
- NCT05473013 · 264 participants · NA
Optimizing Digital Health Technology Interventions to Increase Skill Acquisition and Utilization
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI