A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

NCT ID: NCT00542815

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 632 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-08-31

Brief Summary

This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks

Detailed Description

Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.

Conditions

Chronic Kidney Disease; Dialysis; Hyperphosphatemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

MCI-196

Intervention Type: DRUG

3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose

2

Group Type: ACTIVE_COMPARATOR

Another Phosphate binder (Sevelamer)

Intervention Type: DRUG

Current approved dosing recommendations for 12 weeks

Interventions

MCI-196

3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose

Intervention Type: DRUG

Another Phosphate binder (Sevelamer)

Current approved dosing recommendations for 12 weeks

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• Clinically stable haemodialysis or peritoneal dialysis treatment.
• Stable phosphate control
• Stabilised phosphorus diet.
• female subjects of child-bearing potential must have a negative serum pregnancy test.
• Male subjects must agree to use appropriate contraception.
• Completed one of the MCI-196 PIII studies

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.
• Body Mass Index (BMI) <= 16.0 kg/m2 or =>40.0 kg/m2.
• Current or a history of significant gastrointestinal motility problems
• Positive test for HIV 1 and 2 antibodies.
• History of substance or alcohol abuse within the last year.
• Seizure disorders.
• History of drug or other allergy.
• Temporary catheter with active signs of inflammation or infection.
• The subject has participated in a clinical study with any experimental medication (with the exception of MCI-196 PIII studies) in the last 30days or experimental biological product within the 90 days prior to signing of informed consent form.

• 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

Graz, , Austria

Frýdek-Místek, , Czechia

Hradec Králové, , Czechia

Ostrava, , Czechia

Prague, , Czechia

Tábor, , Czechia

Ústí nad Labem, , Czechia

Bordeaux, , France

Montpelier, , France

Paris, , France

Aschaffenburg, , Germany

Coesfeld, , Germany

Darmstadt, , Germany

Dortmund, , Germany

Düsseldorf, , Germany

Hamburg, , Germany

Homberg (Efze), , Germany

Langen, , Germany

Mannheim-Kafertal, , Germany

Ajka, , Hungary

Baja, , Hungary

Budapest, , Hungary

Esztergom, , Hungary

Győr, , Hungary

Hatvan, , Hungary

Kisvárda, , Hungary

Veszprém, , Hungary

Ancona, , Italy

Cernusco sul Naviglio, , Italy

Como, , Italy

Cremona, , Italy

Lecco, , Italy

Livorno, , Italy

Milan, , Italy

Modena, , Italy

Ostia Roma, , Italy

Pavia, , Italy

Perugia, , Italy

Rome, , Italy

Alor Star, , Malaysia

Klang, , Malaysia

Kota Kinabalu, , Malaysia

Kuala Terengganu, , Malaysia

Kuching, , Malaysia

Malacca, , Malaysia

Selangor Darul Ehsan, , Malaysia

Seremban, , Malaysia

Taiping, , Malaysia

Skopje, , North Macedonia

Ciechanów, , Poland

Częstochowa, , Poland

Gdansk, , Poland

Lodz, , Poland

Lublin, , Poland

Oświęcim, , Poland

Pabianice, , Poland

Poznan, , Poland

Rybnik, , Poland

Sokołów Podlaski, , Poland

Starogard Gdański, , Poland

Warsaw, , Poland

Wejherowo, , Poland

Wroclaw, , Poland

Zgierz, , Poland

Zielona Góra, , Poland

Arkhangelsk, , Russia

Chita, , Russia

Irkutsk, , Russia

Ivanovo, , Russia

Kaluga, , Russia

Karbysheva str.Volzskiy, , Russia

Kemerovo, , Russia

Khabarovsk, , Russia

Krasnodar, , Russia

Krasnoyarsk, , Russia

Moscow, , Russia

Mytishchi, , Russia

Nizhny Novgorod, , Russia

Novokuznetsk, , Russia

Novorossiysk, , Russia

Novosibirsk, , Russia

Omsk, , Russia

Petrozavodsk, , Russia

Rostov-on-Don, , Russia

Rozhkova, , Russia

Saint Petersburg, , Russia

Smolensk, , Russia

Tomsk, , Russia

Vladivostok, , Russia

Yaroslavl, , Russia

Yekaterinburg, , Russia

Belgrade, , Serbia

Kragujevac, , Serbia

Niš, , Serbia

Novi Sad, , Serbia

Cape Town, , South Africa

Durban, , South Africa

Gauteng, , South Africa

Johannesburg, , South Africa

Port Elizabeth, , South Africa

Barcelona, , Spain

Oviedo, , Spain

Seville, , Spain

Chernivtsy, , Ukraine

Dnipro, , Ukraine

Ivano-Frankivsk, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Mykolayiv, , Ukraine

Ternopil, , Ukraine

Uzhhorod, , Ukraine

Zaporizhya, , Ukraine

Zhytomyr, , Ukraine

Glasgow, , United Kingdom

Stevenage, , United Kingdom

Countries

Austria; Czechia; France; Germany; Hungary; Italy; Malaysia; North Macedonia; Poland; Russia; Serbia; South Africa; Spain; Ukraine; United Kingdom

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-E10

Identifier Type: -

Identifier Source: org_study_id