Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for dialysis patients: drug AP301 targets dangerous phosphate levels

NCT ID NCT06933472

Disease control Sponsor: Alebund Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether AP301, a drug taken with meals, can safely lower high blood phosphate in people on kidney dialysis. About 264 participants will receive either AP301 or a low-dose version for 8 weeks, then all get AP301 for 24 weeks. The goal is to see if AP301 helps control phosphate levels and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AP301 (a phosphate binder taken orally with meals)
What this could lead to
If it works, AP301 could offer a new option to control high blood phosphate in dialysis patients, potentially improving their health and quality of life.
What could go wrong
This is a phase 3 trial, but the comparator is a low dose of AP301, not a placebo, which may limit how well we can judge effectiveness. Also, results may not apply to all dialysis patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 264 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic kidney disease with hyperphosphatemia on maintenance dialysis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure hyperphosphatemia wild type ABeta2M amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney disease, receiving dialysis Dialysis ESRD (end-stage renal disease) Hyperphosphatemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    42 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tsinghua Chang Gung Hospital

    RECRUITING

    Beijing, Beijing Municipality, 102218, China

  • Central South University-The Third Xiangya Hospital

    RECRUITING

    Changsha, Hunan, 410013, China

  • Children's Hospital of Fudan University

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200080, China

  • Dallas Renal Group - Dallas

    RECRUITING

    Dallas, Texas, 75237, United States

  • Fudan University-Huashan Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Fudan University-Zhongshan Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Gamma Medical Research

    RECRUITING

    McAllen, Texas, 78503, United States

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • High Desert Nephrology Association - US Renal Care

    RECRUITING

    Gallup, New Mexico, 87301, United States

  • Huazhong University of Science and Technology-Tongji Medical College - Wuhan Union Hospital

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jiangxi Provincial People's Hospital

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • NY Kidney & Hypertension Medicine

    RECRUITING

    Ridgewood, New York, 11385, United States

  • Nanjing Medical University-Wuxi People's Hospital (Wuxi No.1 People's Hospital)

    RECRUITING

    Wuxi, Jiangsu, 214023, China

  • Nantong University-Affiliated Hospital

    RECRUITING

    Nantong, Jiangsu, 226001, China

  • Nephrology & Hypertension Associates Ltd - Tupelo

    RECRUITING

    Tupelo, Mississippi, 38801, United States

  • Nephrology & Hypertension Specialists

    RECRUITING

    Dalton, Georgia, 30720, United States

  • Nephrology Associates, P.C. - Columbus

    RECRUITING

    Columbus, Mississippi, 38801, United States

  • North America Research Institute - San Dimas

    RECRUITING

    San Dimas, California, 91773, United States

  • North America Research Institute - San Dimas

    RECRUITING

    San Dimas, California, 91773, United States

  • PACT Kidney Care - Orange

    RECRUITING

    Orange, Connecticut, 06477, United States

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100035, China

  • Peking University International Hospital

    RECRUITING

    Beijing, Beijing Municipality, 102218, China

  • Qingdao University-The Affiliated Hospital

    RECRUITING

    Qingdao, Shandong, 266000, China

  • Renal Associates Of Baton Rouge, LLC

    RECRUITING

    Baton Rouge, Louisiana, 70808, United States

  • Renal Consultants Medical Group

    RECRUITING

    Granada Hills, California, 91344, United States

  • Rocky Mountain Kidney Care - Lone Tree

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • Shanghai Jiao Tong University School of Medicine (SJTUSM)-Renji Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Shanghai Tongren Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200336, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610072, China

  • Southeast University-Zhongda Hospital

    RECRUITING

    Nanjing, Jiangsu, 210009, China

  • Subei People's Hospital

    RECRUITING

    Yangzhou, Jiangsu, 225002, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • US Renal Care - Alexis

    RECRUITING

    Toledo, Ohio, 43613, United States

  • US Renal Care - Bluebonnet

    RECRUITING

    Fort Worth, Texas, 76110, United States

  • US Renal Care - Fort Myers South

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • US Renal Care - Hill Country

    RECRUITING

    San Antonio, Texas, 78251, United States

  • US Renal Care - South San Antonio

    RECRUITING

    San Antonio, Texas, 78211, United States

  • US Renal Care - West Cheektowaga

    RECRUITING

    Cheektowaga, New York, 14215, United States

  • Wuhan University People's Hospital

    RECRUITING

    Wuhan, Hubei, 430060, China

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, Shandong, 264099, China

  • Zhengzhou University-First Affiliated Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.