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New drug aims to tackle two key risks in kidney dialysis patients

NCT ID NCT00542386

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tested MCI-196, a drug that binds phosphorus and lowers cholesterol, in 642 adults on dialysis with chronic kidney disease. Participants received either MCI-196 or a placebo for 12 weeks. The goal was to see if the drug could safely reduce both serum phosphorus and LDL-cholesterol levels, which are linked to heart and bone problems in dialysis patients.

What this could mean

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

Active substance
MCI-196 (colestilan)
What this could lead to
If it works, this could provide a new option to manage high phosphorus and cholesterol in dialysis patients, potentially reducing heart and bone complications.
What could go wrong
This is a completed Phase 3 trial, but results may not show significant benefit over placebo. Side effects are possible, and the drug may not be approved or widely adopted.

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

642 people

The number who actually took part.

Start date

Dec 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. * A a serum albumin level\<30.0g/L * A PTH level \>1000pg/mL * A body mass index (BMI)\<= 16.0kg/㎡ or =\>40.0kg/㎡ * A serum LDL-C level \>4.94mmol/L(190mg/dL) * A serum triglycerides level \>6.76mmol/L (600mg/dL) * A 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 Dyslipidemias end stage renal failure hyperphosphatemia inherited lipid metabolism disorder 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 Dyslipidemia Hyperphosphatemia

Contacts and locations

Locations

  • Study site

    Ajka, Hungary

  • Study site

    Baja, Hungary

  • Study site

    Budapest, Hungary

  • Study site

    Esztergom, Hungary

  • Study site

    Győr, Hungary

  • Study site

    Hatvan, Hungary

  • Study site

    Kisvárda, Hungary

  • Study site

    Lecco, Italy

  • Study site

    Modena, Italy

  • Study site

    Pavia, Italy

  • Study site

    Roma, Italy

  • Study site

    Alor Star, Malaysia

  • Study site

    Ipoh, Malaysia

  • Study site

    Kajang, Malaysia

  • Study site

    Klang, Malaysia

  • Study site

    Kota Kinabalu, Malaysia

  • Study site

    Kuala Terengganu, Malaysia

  • Study site

    Kuantan, Malaysia

  • Study site

    Kuching, Malaysia

  • Study site

    Malacca, Malaysia

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    Seremban, Malaysia

  • Study site

    Taiping, Malaysia

  • Study site

    Skopje, North Macedonia

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    Lodz, Poland

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    Poznan, Poland

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    Płock, Poland

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    Rybnik, Poland

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    Warsaw, Poland

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    Wroclaw, Poland

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    Zielona Góra, Poland

  • Study site

    Arkhangelsk, Russia

  • Study site

    Armavir, Russia

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    Chelyabinsk, Russia

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    Chita, Russia

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    Irkutsk, Russia

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    Ivanovo, Russia

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    Kaluga, Russia

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    Kemerovo, Russia

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    Khabarovsk, Russia

  • Study site

    Krasnodar, Russia

  • Study site

    Krasnoyarsk, Russia

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    Moscow, Russia

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    Nizhny Novgorod, Russia

  • Study site

    Novokuznetsk, Russia

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    Novorossiysk, Russia

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    Novosibirsk, Russia

  • Study site

    Omsk, Russia

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    Petrozavodsk, Russia

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    Rostov-on-Don, Russia

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    Saint Petersburg, Russia

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    Smolensk, Russia

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    Tomsk, Russia

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    Tver', Russia

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    Tyumen, Russia

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    Vladimir, Russia

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    Vladivostok, Russia

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    Volzhskiy, Russia

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    Yaroslavl, Russia

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    Yekaterinburg, Russia

  • Study site

    Belgrade, Serbia

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    Kragujevac, Serbia

  • Study site

    Niš, Serbia

  • Study site

    Novi Sad, Serbia

  • Study site

    Chernivtsi, Ukraine

  • Study site

    Dnipro, Ukraine

  • Study site

    Ivano-Frankivsk, Ukraine

  • Study site

    Kharkiv, Ukraine

  • Study site

    Kiev, Ukraine

  • Study site

    Mykolaiv, Ukraine

  • Study site

    Ternopil, Ukraine

  • Study site

    Uzhhorod, Ukraine

  • Study site

    Zaporizhya, Ukraine

  • Study site

    Zhytomyr, Ukraine

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