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New pill could help dialysis patients control dangerous phosphate levels

NCT ID NCT06712654

Disease control Sponsor: R1 Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 15 times

Summary

This study tests a new drug called AP306 in 168 adults on maintenance hemodialysis who have high phosphate levels (hyperphosphatemia). Participants take one of several fixed doses of AP306 or a placebo daily for 8 weeks. The main goal is to see if AP306 safely lowers blood phosphate, a common and serious complication in kidney failure.

What this could mean

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

Active substance
AP306 (a drug taken by mouth to lower phosphate levels in the blood)
What this could lead to
If it works, this could offer a new treatment option to help control high phosphate levels in people on dialysis, potentially reducing related health risks.
What could go wrong
This is an early phase 2b trial with only 168 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 168 people

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

Started

Jun 2026

Expected to finish

Mar 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

18 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.

Important Inclusion Criteria: * Signs a written informed consent form (ICF) and is willing to comply with all study requirements in the study * Receiving a stable hemodialysis (including hemodialysis, hemodiafiltration, and hemoadsorption) regimen, which is defined as a frequency of three times per week for at least 12 weeks before signing the ICF, and does not plan to change in the study * Who has a blood phosphate level within the study-required range * Who has a dialysis adequacy, assessed by single pooled Kt/V (SpKt/V, estimated with blood urea) ≥1.20, at screening or any documented value ≥1.20 within 12 weeks prior to signing the ICF * If the participant is receiving etelcalcetide, their doses must be unchanged for at least 4 weeks prior to signing the ICF * If the participant is receiving any of the following therapies, their doses are stable for at least 14 days prior to signing the ICF: phosphate-lowering products other than tenapanor or phosphate binders, active vitamin D and analogs, cinacalcet, calcitonin, and P-glycoprotein inhibitors * Agreement to use highly effective contraception for women of childbearing potentially and non-sterile sexually active males throughout the study and for 90 days after the final dose of study drug Important Exclusion Criteria: * Pregnant or breastfeeding * Scheduled for a living donor kidney transplant in the next 6 months, planned change to peritoneal dialysis or home hemodialysis in the study; planned relocation to another dialysis center in the study * Any history of a non-pharmacological parathyroid intervention within 6 months prior to the ICF sign off, or planned parathyroid intervention in the study * Blood calcium or blood intact parathyroid hormone abnormality * Adequate organ and bone marrow function * Acute hepatitis or significant chronic liver disease * Any clinically significant GI disorders within 4 weeks prior to signing the ICF; or any history of gastrectomy; or any GI tract surgery (excluding appendectomy and polypectomy), within 12 weeks of signing the ICF * Uncontrolled hypertension * Hospitalization for cardiac or cardiocerebrovascular disease within 24 weeks prior to signing the ICF * Significant abnormalities of QT interval and heart rhythm on an electrocardiograph (ECG) test * Any clinically significant active infection or infestation or any treatment with systemic antimicrobial treatment within 2 weeks prior to signing the ICF * History or presence of malignancy within 3 years prior to signing the ICF, except basal cell skin cancer, in-situ carcinoma of the cervix, and in-situ prostate cancer * Taking moderate or strong cytochrome P450 (CYP) 3A inhibitors within 2 weeks or 5 half-lives, whichever is longer, prior to signing the ICF (topical use is allowed) * Treatment with any investigational medication or medical device within 30 days prior to signing the ICF * Life expectancy less than 12 months

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Conditions

The condition(s) this trial relates to.

end stage renal failure hyperphosphatemia

As listed by the trial registrant

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

Chronic kidney disease requiring chronic dialysis End stage renal disease on dialysis Hyperphosphatemia

How to take part

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

  1. The places running it

    31 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

  • Academic Medical Research Institute

    RECRUITING

    Los Angeles, California, 90022, United States

  • Apogee Clinical Research, LLC

    RECRUITING

    Huntsville, Alabama, 35801, United States

  • California Institute of Renal Research

    RECRUITING

    Chula Vista, California, 91910, United States

  • Colorado Kidney Care

    RECRUITING

    Denver, Colorado, 80220, United States

  • DaVita Clinical Research

    RECRUITING

    Middlebury, Connecticut, 06762, United States

  • DaVita Clinical Research

    RECRUITING

    Las Vegas, Nevada, 89107, United States

  • DaVita Clinical Research

    RECRUITING

    Houston, Texas, 77054, United States

  • DaVita Clinical Research Edina

    RECRUITING

    Edina, Minnesota, 55435, United States

  • DaVita Clinical Research Norfolk

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • DaVita Clinical Research San Antonio

    RECRUITING

    San Antonio, Texas, 78258, United States

  • Gamma Medical Research

    RECRUITING

    McAllen, Texas, 78503, United States

  • Johnson County Clinical Trials

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • NY Kidney & Hypertension Medicine

    RECRUITING

    Ridgewood, New York, 11385, United States

  • Nephrology & Hypertension Specialists

    RECRUITING

    Dalton, Georgia, 30720, United States

  • North America Research Institute

    RECRUITING

    San Dimas, California, 91773, United States

  • PACT Kidney Care

    RECRUITING

    Orange, Connecticut, 06477, United States

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100035, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • R1 Therapeutics Clinical Trial Site

    RECRUITING

    Albuquerque, New Mexico, 87109, United States

  • Shanghai Jiao Tong University School of Medicine, Renji Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 201112, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610072, China

  • St. Clair Nephrology Research

    RECRUITING

    Shelby, Michigan, 48315, United States

  • Sunbeam Research

    RECRUITING

    Greenville, Texas, 75402, United States

  • The Second Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210003, China

  • US Renal Care

    RECRUITING

    Waxahachie, Texas, 75165, United States

  • US Renal Care - Alexis

    RECRUITING

    Toledo, Ohio, 43613, United States

  • US Renal Care - Fort Myers South

    RECRUITING

    Fort Myers, Florida, 33912, United States

  • US Renal Care - South San Antonio

    RECRUITING

    San Antonio, Texas, 35801, United States

  • US Renal Care - Westover Hills

    RECRUITING

    San Antonio, Texas, 78251, United States

  • Zhengzhou University-First Affiliated Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Zhongda Hospital Southeast University

    RECRUITING

    Nanjing, Jiangsu, 210009, China

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