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New hope for dialysis patients: drug shows promise in lowering dangerous phosphorus levels

NCT ID NCT00416520

Disease control Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called MCI-196 in 336 adults on dialysis with chronic kidney disease and high phosphorus levels. After a washout period, some patients received MCI-196 and others a placebo to see if the drug could safely lower phosphorus. The goal was to manage a common complication of kidney failure, not to cure the disease.

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

336 people

The number who actually took part.

Start date

Jun 2007

Finished

Nov 2009

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.

Inclusion Criteria: * Male or female, 18 years of age or over * Clinically stable haemodialysis or peritoneal dialysis * Stable phosphate control * On a stabilised phosphorus diet * Female and of child-bearing potential have a negative serum pregnancy test. * Male subjects must agree to use appropriate contraception. Exclusion Criteria: * Current clinically significant medical comorbidities, which may substantially compromise subject safety, or expose them to undue risk, or interfere significantly with study procedures and which, in the opinion of the Investigator, makes the subject unsuitable for inclusion in the study. * Body Mass Index (BMI) \<=16.0 kg/m2 or \>=40.0 kg/m2 * A current or history of significant gastrointestinal motility problems * A positive test for HIV 1 and 2 antibodies * A history of substance or alcohol abuse within the last year. * Seizure disorders * A history of drug or other allergy * A temporary catheter as a vascular access * Participated in a clinical study with any experimental medication in the last 30 days or an experimental biological product within the last 90 days prior to signing of informed consent

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome 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 Hyperphosphatemia

Contacts and locations

Locations

  • Study site

    Adelaide, Australia

  • Study site

    Nedlands, Australia

  • Study site

    Parkville, Australia

  • Study site

    St Leonards, Australia

  • Study site

    Sydney, Australia

  • Study site

    Woolloongabba, Australia

  • Study site

    Graz, Austria

  • Study site

    Frýdek-Místek, Czechia

  • Study site

    HradecKralove, Czechia

  • Study site

    Ostrava, Czechia

  • Study site

    Prague, Czechia

  • Study site

    Tábor, Czechia

  • Study site

    Ústí nad Labem, Czechia

  • Study site

    Bordeaux, France

  • Study site

    Montpelier, France

  • Study site

    Paris, France

  • Study site

    Aachen, Germany

  • Study site

    Aschaffenburg, Germany

  • Study site

    Coburg, Germany

  • Study site

    Coesfeld, Germany

  • Study site

    Darmstadt, Germany

  • Study site

    Dieburg, Germany

  • Study site

    Dortmund, Germany

  • Study site

    Düsseldorf, Germany

  • Study site

    Hamburg, Germany

  • Study site

    Homberg (Efze), Germany

  • Study site

    Langen, Germany

  • Study site

    Mannheim-Kafertal, Germany

  • Study site

    München, Germany

  • Study site

    Potsdam-Babelsberg, Germany

  • Study site

    Baja, Hungary

  • Study site

    Budapest, Hungary

  • Study site

    Kisvárda, Hungary

  • Study site

    Veszprém, Hungary

  • Study site

    Biella, Italy

  • Study site

    Como, Italy

  • Study site

    Cremona, Italy

  • Study site

    Lecco, Italy

  • Study site

    Livorno, Italy

  • Study site

    Milan, Italy

  • Study site

    Pavia, Italy

  • Study site

    Perugia, Italy

  • Study site

    Rome, Italy

  • Study site

    Ciechanów, Poland

  • Study site

    Częstochowa, Poland

  • Study site

    Gdansk, Poland

  • Study site

    Krakow, Poland

  • Study site

    Lodz, Poland

  • Study site

    Lublin, Poland

  • Study site

    Oświęcim, Poland

  • Study site

    Pabianice, Poland

  • Study site

    Rybnik, Poland

  • Study site

    Sokołów Podlaski, Poland

  • Study site

    Starogard Gdański, Poland

  • Study site

    Warsaw, Poland

  • Study site

    Wejherowo, Poland

  • Study site

    Zgierz, Poland

  • Study site

    Zielona Góra, Poland

  • Study site

    Cape Town, South Africa

  • Study site

    Durban, South Africa

  • Study site

    Gauteng, South Africa

  • Study site

    Johannesburg, South Africa

  • Study site

    Port Elizabeth, South Africa

  • Study site

    Barcelona, Spain

  • Study site

    Oviedo, Spain

  • Study site

    Seville, Spain

  • Study site

    Glasgow, United Kingdom

  • Study site

    Stevenage, United Kingdom

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