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New drug shows promise in managing phosphorus for kidney patients on dialysis

NCT ID NCT00542815

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

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 the long-term safety of a drug called MCI-196 in 632 adults with chronic kidney disease on dialysis who have high phosphorus levels. Participants took the drug for up to 52 weeks to see how it affected their phosphorus and cholesterol. The goal was to help control these levels safely over time.

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

632 people

The number who actually took part.

Start date

Nov 2007

Finished

Aug 2010

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Clinically stable haemodialysis or peritoneal dialysis treatment. * Stable phosphate control * Stabilised phosphorus diet. * female subjects of child-bearing potential must have a negative serum pregnancy test. * Male subjects must agree to use appropriate contraception. * Completed one of the MCI-196 PIII studies 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. * Current or a history of significant gastrointestinal motility problems * Positive test for HIV 1 and 2 antibodies. * History of substance or alcohol abuse within the last year. * Seizure disorders. * History of drug or other allergy. * Temporary catheter with active signs of inflammation or infection. * The subject has participated in a clinical study with any experimental medication (with the exception of MCI-196 PIII studies) in the last 30days or experimental biological product within the 90 days prior to signing of informed consent form.

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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 Dialysis Hyperphosphatemia

Contacts and locations

Locations

  • Study site

    Graz, Austria

  • Study site

    Frýdek-Místek, Czechia

  • Study site

    Hradec Králové, 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

    Aschaffenburg, Germany

  • Study site

    Coesfeld, Germany

  • Study site

    Darmstadt, 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

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    Ajka, Hungary

  • Study site

    Baja, Hungary

  • Study site

    Budapest, Hungary

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    Esztergom, Hungary

  • Study site

    Győr, Hungary

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    Hatvan, Hungary

  • Study site

    Kisvárda, Hungary

  • Study site

    Veszprém, Hungary

  • Study site

    Ancona, Italy

  • Study site

    Cernusco sul Naviglio, Italy

  • Study site

    Como, Italy

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    Cremona, Italy

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    Lecco, Italy

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    Livorno, Italy

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    Milan, Italy

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    Modena, Italy

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    Ostia Roma, Italy

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    Pavia, Italy

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    Perugia, Italy

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    Rome, Italy

  • Study site

    Alor Star, Malaysia

  • Study site

    Klang, Malaysia

  • Study site

    Kota Kinabalu, Malaysia

  • Study site

    Kuala Terengganu, Malaysia

  • Study site

    Kuching, Malaysia

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    Malacca, Malaysia

  • Study site

    Selangor Darul Ehsan, Malaysia

  • Study site

    Seremban, Malaysia

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    Taiping, Malaysia

  • Study site

    Skopje, North Macedonia

  • Study site

    Ciechanów, Poland

  • Study site

    Częstochowa, Poland

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    Gdansk, Poland

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    Lodz, Poland

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    Lublin, Poland

  • Study site

    Oświęcim, Poland

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    Pabianice, Poland

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    Poznan, Poland

  • Study site

    Rybnik, Poland

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    Sokołów Podlaski, Poland

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    Starogard Gdański, Poland

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    Warsaw, Poland

  • Study site

    Wejherowo, Poland

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    Wroclaw, Poland

  • Study site

    Zgierz, Poland

  • Study site

    Zielona Góra, Poland

  • Study site

    Arkhangelsk, Russia

  • Study site

    Chita, Russia

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    Irkutsk, Russia

  • Study site

    Ivanovo, Russia

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    Kaluga, Russia

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    Karbysheva str.Volzskiy, Russia

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    Kemerovo, Russia

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    Khabarovsk, Russia

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    Krasnodar, Russia

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    Krasnoyarsk, Russia

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    Moscow, Russia

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    Mytishchi, Russia

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    Nizhny Novgorod, Russia

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    Novokuznetsk, Russia

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    Novorossiysk, Russia

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    Novosibirsk, Russia

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    Omsk, Russia

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    Petrozavodsk, Russia

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    Rostov-on-Don, Russia

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    Rozhkova, Russia

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    Saint Petersburg, Russia

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    Smolensk, Russia

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    Tomsk, Russia

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    Vladivostok, Russia

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    Yaroslavl, Russia

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    Yekaterinburg, Russia

  • Study site

    Belgrade, Serbia

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    Kragujevac, Serbia

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    Niš, Serbia

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    Novi Sad, Serbia

  • Study site

    Cape Town, South Africa

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    Durban, South Africa

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    Gauteng, South Africa

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    Johannesburg, South Africa

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    Port Elizabeth, South Africa

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    Barcelona, Spain

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    Oviedo, Spain

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    Seville, Spain

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    Chernivtsy, Ukraine

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    Dnipro, Ukraine

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    Ivano-Frankivsk, Ukraine

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    Kharkiv, Ukraine

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    Kiev, Ukraine

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    Mykolayiv, Ukraine

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    Ternopil, Ukraine

  • Study site

    Uzhhorod, Ukraine

  • Study site

    Zaporizhya, Ukraine

  • Study site

    Zhytomyr, Ukraine

  • Study site

    Glasgow, United Kingdom

  • Study site

    Stevenage, United Kingdom

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