A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
Alebund Pharmaceuticals · with Fortrea · NCT06933472
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 12+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 264
- US sites recruiting
- 19
- Study start
- June 13, 2025
- Record last updated
- January 29, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: AP301; AP301 Low Dose
Conditions: Hyperphosphatemia; Chronic Kidney Disease, Receiving Dialysis; ESRD (End-Stage Renal Disease); Dialysis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Key Inclusion Criteria
- Provision of signed and dated ICF
- Age ≥ 12 years when signing the ICF
- Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
- For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
- Patients who receive phosphate-lowering drugs over 4 weeks and their serum phosphate level is:
- 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)
Key Exclusion Criteria
- History or plan of kidney transplantation
- History or plan of parathyroid intervention 6 months before signing the ICF
- Serum calcium \< 1.9 mmol/L (7.6 mg/dL) or > 2.75 mmol/L (11 mg/dL) at screening
- Serum intact parathyroid hormone > 127 pmol/L (1200 pg/mL) at screening
- Presence of clinically significant gastrointestinal (GI) disorder
- History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF
- Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care
- Female who are breastfeeding
Recruiting US locations
Renal Consultants Medical Group
Granada Hills, CA 91344
Site contact: Dayan Gandhi, M.D. · drg@renalconsultants.com
North America Research Institute - San Dimas
San Dimas, CA 91773
Site contact: Nitin Bhasin, M.D. · nbhasin@nariresearch.com
North America Research Institute - San Dimas
San Dimas, CA 91773
Site contact: Aamir Jamal, M.D. · ajamal@nariresearch.com
Rocky Mountain Kidney Care - Lone Tree
Lone Tree, CO 80124
Site contact: Geoffrey Block, M.D. · geoff.block@usrenalcare.com
PACT Kidney Care - Orange
Orange, CT 06477
Site contact: Peter Chuang, M.D. · pchuang@pactmd.com
US Renal Care - Fort Myers South
Fort Myers, FL 33912
Site contact: Mary Mouracade, M.D. · mmouracade@associatesnephrology.com
Nephrology & Hypertension Specialists
Dalton, GA 30720
Site contact: Frank Newby, M.D. · dnewby@kidneydocs.net
Renal Associates Of Baton Rouge, LLC
Baton Rouge, LA 70808
Site contact: Michael Roppollo, M.D. · mroppolo@renalassociates.com
Nephrology Associates, P.C. - Columbus
Columbus, MS 38801
Site contact: Angela Riley, M.D. · ariley@nakidneydocs.com
Nephrology & Hypertension Associates Ltd - Tupelo
Tupelo, MS 38801
Site contact: Thomas Wooldridge, M.D. · TDWooldridgeResearch@gmail.com
High Desert Nephrology Association - US Renal Care
Gallup, NM 87301
Site contact: Ayodele Erinle, M.D. · Aerinle@hdnakidney.com
US Renal Care - West Cheektowaga
Cheektowaga, NY 14215
Site contact: Imad Ahmed, M.D. · imad16th@yahoo.com
NY Kidney & Hypertension Medicine
Ridgewood, NY 11385
Site contact: Jodumutt Bhat, M.D. · jbhat@atlanticdialysis.com
US Renal Care - Alexis
Toledo, OH 43613
Site contact: Ramy Fayad, M.D. · ramyfayad@hotmail.com
Dallas Renal Group - Dallas
Dallas, TX 75237
Site contact: Ajay Kallam, M.D. · akallam@dallasrenalgroup.com
US Renal Care - Bluebonnet
Fort Worth, TX 76110
Site contact: Raju Patil, M.D. · rpatil@fortworthrenal.com
Gamma Medical Research
McAllen, TX 78503
Site contact: Roberto Manllo-Karim · rmangoo@gmail.com
US Renal Care - South San Antonio
San Antonio, TX 78211
Site contact: Carolina Arias, M.D. · carias@texaskidneycare.com
US Renal Care - Hill Country
San Antonio, TX 78251
Site contact: Varshasb Broumand, M.D. · vbroumand@texaskidneycare.com
Study contacts (from the official record)
- Weifeng Zhang, M.D. · +8618602184576 · weifeng.zhang@alebund.com
- Bobby Zang · +8613661683813 · bobby.zang@alebund.com