A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

NCT ID: NCT00542386

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 642 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-11-30

Brief Summary

This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.

Conditions

Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

MCI-196

Intervention Type: DRUG

3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

Interventions

MCI-196

3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

Intervention Type: DRUG

Placebo

3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

Intervention Type: DRUG

Other Intervention Names

Colestilan(INN),; Colestimide(JAN); CHOLEBINE®; BindRen®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor

Role: PRINCIPAL_INVESTIGATOR

Information at Mitsubishi Pharma Europe

Locations

Ajka, , Hungary

Baja, , Hungary

Budapest, , Hungary

Esztergom, , Hungary

Győr, , Hungary

Hatvan, , Hungary

Kisvárda, , Hungary

Lecco, , Italy

Modena, , Italy

Pavia, , Italy

Roma, , Italy

Alor Star, , Malaysia

Ipoh, , Malaysia

Kajang, , Malaysia

Klang, , Malaysia

Kota Kinabalu, , Malaysia

Kuala Terengganu, , Malaysia

Kuantan, , Malaysia

Kuching, , Malaysia

Malacca, , Malaysia

Seremban, , Malaysia

Taiping, , Malaysia

Skopje, , North Macedonia

Lodz, , Poland

Poznan, , Poland

Płock, , Poland

Rybnik, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Zielona Góra, , Poland

Arkhangelsk, , Russia

Armavir, , Russia

Chelyabinsk, , Russia

Chita, , Russia

Irkutsk, , Russia

Ivanovo, , Russia

Kaluga, , Russia

Kemerovo, , Russia

Khabarovsk, , Russia

Krasnodar, , Russia

Krasnoyarsk, , Russia

Moscow, , Russia

Nizhny Novgorod, , Russia

Novokuznetsk, , Russia

Novorossiysk, , Russia

Novosibirsk, , Russia

Omsk, , Russia

Petrozavodsk, , Russia

Rostov-on-Don, , Russia

Saint Petersburg, , Russia

Smolensk, , Russia

Tomsk, , Russia

Tver', , Russia

Tyumen, , Russia

Vladimir, , Russia

Vladivostok, , Russia

Volzhskiy, , Russia

Yaroslavl, , Russia

Yekaterinburg, , Russia

Belgrade, , Serbia

Kragujevac, , Serbia

Niš, , Serbia

Novi Sad, , Serbia

Chernivtsi, , Ukraine

Dnipro, , Ukraine

Ivano-Frankivsk, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Mykolaiv, , Ukraine

Ternopil, , Ukraine

Uzhhorod, , Ukraine

Zaporizhya, , Ukraine

Zhytomyr, , Ukraine

Countries

Hungary; Italy; Malaysia; North Macedonia; Poland; Russia; Serbia; Ukraine

References

Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type: DERIVED

PMID: 40576086 (View on PubMed)

Other Identifiers

MCI-196-E08

Identifier Type: -

Identifier Source: org_study_id