Recruiting
Phase 3

AP301

Sponsor:

Alebund Pharmaceuticals

Code:

NCT06933472

Conditions

Hyperphosphatemia

Chronic Kidney Disease, Receiving Dialysis

ESRD (End-Stage Renal Disease)

Dialysis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

AP301

AP301 Low Dose

Study Details

Brief 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.

Conditions

Hyperphosphatemia

Chronic Kidney Disease, Receiving Dialysis

ESRD (End-Stage Renal Disease)

Dialysis

Study ID

NCT06933472

Start date

Jun 13, 2025

Status verified date

Jun, 2025

Completion date

Jan 10, 2027

Anticipated

Primary completion date

Jun 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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:

1. Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate < 2.58 mmol/L (8.0 mg/dL)
2. 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

Study Design

Enrollment

264 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AP301

A blood phosphate-lowering medication containing iron

experimental: AP301 Low Dose

A blood phosphate-lowering medication containing iron, but with a low dose considered as ineffective

Interventions

AP301

Three times a day, administered orally with three meals at a daily dose level from 2.7g to 9.0g

AP301 Low Dose

Three times a day, administered orally with three meals at a daily dose level from 0.075g to 0.25g

Primary outcome measure

  • Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups [ Time Frame: From Baseline to the end of Week 8 ]

Central Contacts and Locations

Central contacts

Weifeng Zhang, M.D.

+8618602184576weifeng.zhang@alebund.com

Bobby Zang

+8613661683813bobby.zang@alebund.com

Locations

Renal Consultants Medical Group

Recruiting

Granada Hills, California, United States, 91344

Contacts

Dayan Gandhi, M.D.

drg@renalconsultants.com

North America Research Institute - San Dimas

Recruiting

San Dimas, California, United States, 91773

Contacts

Nitin Bhasin, M.D.

nbhasin@nariresearch.com

North America Research Institute - San Dimas

Recruiting

San Dimas, California, United States, 91773

Contacts

Aamir Jamal, M.D.

ajamal@nariresearch.com

Rocky Mountain Kidney Care - Lone Tree

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Geoffrey Block, M.D.

geoff.block@usrenalcare.com

PACT Kidney Care - Orange

Recruiting

Orange, Connecticut, United States, 06477

Contacts

Peter Chuang, M.D.

pchuang@pactmd.com

US Renal Care - Fort Myers South

Recruiting

Fort Myers, Florida, United States, 33912

Contacts

Mary Mouracade, M.D.

mmouracade@associatesnephrology.com

Nephrology & Hypertension Specialists

Recruiting

Dalton, Georgia, United States, 30720

Contacts

Frank Newby, M.D.

dnewby@kidneydocs.net

Renal Associates Of Baton Rouge, LLC

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Michael Roppollo, M.D.

mroppolo@renalassociates.com

Nephrology Associates, P.C. - Columbus

Recruiting

Columbus, Mississippi, United States, 38801

Contacts

Angela Riley, M.D.

ariley@nakidneydocs.com

Nephrology & Hypertension Associates Ltd - Tupelo

Recruiting

Tupelo, Mississippi, United States, 38801

Contacts

Thomas Wooldridge, M.D.

TDWooldridgeResearch@gmail.com

High Desert Nephrology Association - US Renal Care

Recruiting

Gallup, New Mexico, United States, 87301

Contacts

Ayodele Erinle, M.D.

Aerinle@hdnakidney.com

US Renal Care - West Cheektowaga

Recruiting

Cheektowaga, New York, United States, 14215

Contacts

Imad Ahmed, M.D.

imad16th@yahoo.com

NY Kidney & Hypertension Medicine

Recruiting

Ridgewood, New York, United States, 11385

Contacts

Jodumutt Bhat, M.D.

jbhat@atlanticdialysis.com

US Renal Care - Alexis

Recruiting

Toledo, Ohio, United States, 43613

Contacts

Ramy Fayad, M.D.

ramyfayad@hotmail.com

Dallas Renal Group - Dallas

Recruiting

Dallas, Texas, United States, 75237

Contacts

Ajay Kallam, M.D.

akallam@dallasrenalgroup.com

US Renal Care - Bluebonnet

Recruiting

Fort Worth, Texas, United States, 76110

Contacts

Raju Patil, M.D.

rpatil@fortworthrenal.com

Gamma Medical Research

Recruiting

McAllen, Texas, United States, 78503

Contacts

Roberto Manllo-Karim

rmangoo@gmail.com

US Renal Care - South San Antonio

Recruiting

San Antonio, Texas, United States, 78211

Contacts

Carolina Arias, M.D.

carias@texaskidneycare.com

US Renal Care - Hill Country

Recruiting

San Antonio, Texas, United States, 78251

Contacts

Varshasb Broumand, M.D.

vbroumand@texaskidneycare.com

More Information

Sponsor

Alebund Pharmaceuticals

Last update posted

Jan 29, 2026

Last verified

Jun, 2025

Keywords

  • Hyperphosphatemia
  • AP301
  • Dialysis
  • ESKD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Alebund Pharmaceuticals on 2026-01-29.