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New hope for dialysis patients: drug targets dangerous phosphate levels

NCT ID NCT00506441

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

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a drug called MCI-196 in 245 adults on dialysis who have high phosphate levels, a common problem in advanced kidney disease. After a 4-week washout and 12-week dose adjustment, patients were randomly assigned to continue MCI-196 or switch to a placebo for 4 weeks. The main goal was to see if the drug keeps phosphate levels lower than placebo.

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

245 people

The number who actually took part.

Start date

Sep 2007

Finished

Sep 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, and is \>=18 years old * Stable hemodialysis or peritoneal dialysis * Subjects has Stable phosphate control * Subjects on Stabilized phosphorus diet * Subjects undergoing regular dialysis treatment * 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. * serum albumin level \< 3.0g/dL * PTH level \> 1000pg/mL * Hemoglobin level \< 8mg/dL * A History of significant gastrointestinal motility problems * Biliary obstruction or proven liver dysfunction * A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies * A clinically significant severe lactose intolerance or sensitivity * A history of substance or alcohol abuse within the last year. * Seizure disorders * A history of drug or other allergy * using cholestyramine, colestipol or colesevelam * Schedule to receive a kidney transplant within the next 6 months * Participation 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 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

    Glendale, Arizona, United States

  • Study site

    Tempe, Arizona, United States

  • Study site

    Hot Springs, Arkansas, United States

  • Study site

    Paragould, Arkansas, United States

  • Study site

    Pine Bluff, Arkansas, United States

  • Study site

    Fountain Valley, California, United States

  • Study site

    La Mesa, California, United States

  • Study site

    Long Beach, California, United States

  • Study site

    Lynwood, California, United States

  • Study site

    Orange, California, United States

  • Study site

    San Diego, California, United States

  • Study site

    Whittier, California, United States

  • Study site

    Brandon, Florida, United States

  • Study site

    Hudson, Florida, United States

  • Study site

    Lauderdale Lakes, Florida, United States

  • Study site

    Tampa, Florida, United States

  • Study site

    Augusta, Georgia, United States

  • Study site

    Decatur, Georgia, United States

  • Study site

    Macon, Georgia, United States

  • Study site

    Evanston, Illinois, United States

  • Study site

    Evergreen Park, Illinois, United States

  • Study site

    Fort Wayne, Indiana, United States

  • Study site

    Shreveport, Louisiana, United States

  • Study site

    Springfield, Massachusetts, United States

  • Study site

    Eatontown, New Jersey, United States

  • Study site

    Flushing, New York, United States

  • Study site

    Springfield Gardens, New York, United States

  • Study site

    Allentown, Pennsylvania, United States

  • Study site

    Lewistown, Pennsylvania, United States

  • Study site

    Philadelphia, Pennsylvania, United States

  • Study site

    Columbia, South Carolina, United States

  • Study site

    Orangeburg, South Carolina, United States

  • Study site

    Sumter, South Carolina, United States

  • Study site

    San Antonio, Texas, United States

  • Study site

    Alexandria, Virginia, United States

  • Study site

    Portsmouth, Virginia, United States

  • Study site

    Richmond, Virginia, United States

  • Study site

    West Allis, Wisconsin, United States

  • Study site

    San Juan, Puerto Rico

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