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New drug MCI-196 tested for safety in dialysis patients with high phosphorus

NCT ID NCT00772382

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 the long-term safety of a drug called MCI-196 (Colestilan) in 116 adults with stage 5 chronic kidney disease who are on dialysis and have high phosphorus levels. Participants took flexible doses of the drug for 52 weeks. The main goal was to see how many side effects occurred, and the study also checked if the drug helped lower phosphorus levels over time.

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 (also known as Colestilan or Colestimide), a drug taken as a tablet to lower phosphorus levels
What this could lead to
If successful, this could confirm MCI-196 as a safe long-term option to control phosphorus levels in dialysis patients, helping manage a common complication of kidney disease.
What could go wrong
This is a completed phase 3 trial, but it only looked at safety and basic effectiveness in 116 people. Results may not apply to all dialysis patients, and side effects are possible.

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

116 people

The number who actually took part.

Start date

Dec 2008

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

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 have stable phosphate control * Subjects on stabilized phosphorus diet * Subjects undergoing regular dialysis treatment * Females 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 him/her 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/L * 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 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 * 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

    Los Angeles, California, United States

  • Study site

    Orange, California, United States

  • Study site

    Tarzana, California, United States

  • Study site

    Orlando, Florida, United States

  • Study site

    Pembroke Pines, Florida, United States

  • Study site

    Atlanta, Georgia, United States

  • Study site

    Gurnee, Illinois, United States

  • Study site

    Evansville, Indiana, United States

  • Study site

    Baton Rouge, Louisiana, United States

  • Study site

    New Orleans, Louisiana, United States

  • Study site

    Northport, New York, United States

  • Study site

    Durham, North Carolina, United States

  • Study site

    Oklahoma City, Oklahoma, United States

  • Study site

    Nashville, Tennessee, United States

  • Study site

    Houston, Texas, United States

  • Study site

    Burlington, Vermont, United States

  • Study site

    Chesapeake, Virginia, United States

  • Study site

    Kamloops, British Columbia, Canada

  • Study site

    London, Ontario, Canada

  • Study site

    Toronto, Ontario, Canada

  • Study site

    Montreal, Quebec, Canada

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