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New cholesterol drug tested in kidney dialysis patients

NCT ID NCT00858637

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 new drug called MCI-196 to lower bad cholesterol in people with advanced chronic kidney disease who are on dialysis. About 260 adults took part, comparing MCI-196 to a standard statin (simvastatin) and a placebo. The goal was to see if MCI-196 works better than placebo and as well as simvastatin at reducing cholesterol levels.

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

260 people

The number who actually took part.

Start date

Mar 2009

Finished

Mar 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 undergoing regular dialysis treatment * If 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 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 \< 30 g/L * Triglycerides level \> 6.76 mmol/L (600 mg/dL) * LDL-cholesterol level \> 4.94 mmol/L (190 mg/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 * The subject has a history of rhabdomyolysis or myopathy * Schedule to receive a kidney transplant within the next 6 months * The subject has porphyria * 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.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Study site

    Brest, Belarus

  • Study site

    Grodno, Belarus

  • Study site

    Homyel, Belarus

  • Study site

    Minsk, Belarus

  • Study site

    Vitebsk, Belarus

  • Study site

    Gabrovo, Bulgaria

  • Study site

    Plovdiv, Bulgaria

  • Study site

    Sofia, Bulgaria

  • Study site

    Karlovac, Croatia

  • Study site

    Osijek, Croatia

  • Study site

    Esbjerg, Denmark

  • Study site

    Roskilde, Denmark

  • Study site

    Jakarta, Indonesia

  • Study site

    Malang, Indonesia

  • Study site

    Medan, Indonesia

  • Study site

    Palembang, Indonesia

  • Study site

    Tamanlarea Makassar, Indonesia

  • Study site

    Ashkelon, Israel

  • Study site

    Nahariya, Israel

  • Study site

    Bellano, Italy

  • Study site

    Catania, Italy

  • Study site

    Lecco, Italy

  • Study site

    Merate, Italy

  • Study site

    Milan, Italy

  • Study site

    Oggiono, Italy

  • Study site

    Riga, Latvia

  • Study site

    Valmiera, Latvia

  • Study site

    Kaunas, Lithuania

  • Study site

    Kedauniai, Lithuania

  • Study site

    Vilnius, Lithuania

  • Study site

    George Town, Malaysia

  • Study site

    Johor Bahru, Malaysia

  • Study site

    Kelantan, Malaysia

  • Study site

    Perak, Malaysia

  • Study site

    Bucharest, Romania

  • Study site

    Timișoara, Romania

  • Study site

    Singapore, Singapore

  • Study site

    Bangkok, Thailand

  • Study site

    Phitsanulok, Thailand

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