New cholesterol drug tested in kidney dialysis patients
NCT ID NCT00858637
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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260 people
The number who actually took part.
- Start date
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Mar 2009
- Finished
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Mar 2010
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Study site
Brest, Belarus
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Study site
Grodno, Belarus
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Study site
Homyel, Belarus
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Study site
Minsk, Belarus
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Study site
Vitebsk, Belarus
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Study site
Gabrovo, Bulgaria
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Study site
Plovdiv, Bulgaria
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Study site
Sofia, Bulgaria
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Study site
Karlovac, Croatia
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Study site
Osijek, Croatia
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Study site
Esbjerg, Denmark
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Study site
Roskilde, Denmark
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Study site
Jakarta, Indonesia
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Study site
Malang, Indonesia
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Study site
Medan, Indonesia
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Study site
Palembang, Indonesia
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Study site
Tamanlarea Makassar, Indonesia
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Study site
Ashkelon, Israel
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Study site
Nahariya, Israel
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Study site
Bellano, Italy
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Study site
Catania, Italy
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Study site
Lecco, Italy
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Study site
Merate, Italy
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Study site
Milan, Italy
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Study site
Oggiono, Italy
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Study site
Riga, Latvia
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Study site
Valmiera, Latvia
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Study site
Kaunas, Lithuania
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Study site
Kedauniai, Lithuania
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Study site
Vilnius, Lithuania
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Study site
George Town, Malaysia
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Study site
Johor Bahru, Malaysia
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Study site
Kelantan, Malaysia
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Study site
Perak, Malaysia
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Study site
Bucharest, Romania
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Study site
Timișoara, Romania
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Study site
Singapore, Singapore
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Study site
Bangkok, Thailand
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Study site
Phitsanulok, Thailand
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