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

NCT00542386 | Completed Phase 3 Results DMC

• 1 other identifier: MCI-196-E08
• Study Type: interventional
• Target: 642
• Locations: 8 countries
• Sites: 73

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

Keywords

Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Dyslipidemia; Phosphate binder

Outcome Measures

Primary Outcomes (2)

• The Change in Serum Phosphorus

  The change from baseline to week 12

  12 weeks

• The Change in LDL-cholesterol

  The percentage change from baseline to week 12

  12 weeks

Secondary Outcomes (7)

• The Change in Total-cholesterol

  12 weeks

• The Change in HDL-cholesterol

  12 weeks

• The Change in Triglycerides

  12 weeks

• The Change in PTH

  12 weeks

• The Change in Ca

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: MCI-196

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MCI-196 DRUG

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

Also known as: Colestilan(INN),, Colestimide(JAN), CHOLEBINE®, BindRen®

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (73)

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Ajka, Hungary

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Baja, Hungary

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Budapest, Hungary

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Esztergom, Hungary

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Győr, Hungary

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Hatvan, Hungary

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Kisvárda, Hungary

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Lecco, Italy

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Modena, Italy

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Pavia, Italy

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Roma, Italy

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Alor Star, Malaysia

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Ipoh, Malaysia

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Kajang, Malaysia

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Klang, Malaysia

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Kota Kinabalu, Malaysia

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Kuala Terengganu, Malaysia

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Kuantan, Malaysia

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Kuching, Malaysia

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Malacca, Malaysia

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Seremban, Malaysia

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Taiping, Malaysia

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Skopje, North Macedonia

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Lodz, Poland

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Poznan, Poland

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Płock, Poland

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Rybnik, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Zielona Góra, Poland

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Arkhangelsk, Russia

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Armavir, Russia

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Chelyabinsk, Russia

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Chita, Russia

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Irkutsk, Russia

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Ivanovo, Russia

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Kaluga, Russia

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Kemerovo, Russia

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Khabarovsk, Russia

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Krasnodar, Russia

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Krasnoyarsk, Russia

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Moscow, Russia

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Nizhny Novgorod, Russia

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Novokuznetsk, Russia

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Novorossiysk, Russia

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Novosibirsk, Russia

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Omsk, Russia

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Petrozavodsk, Russia

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Rostov-on-Don, Russia

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Saint Petersburg, Russia

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Smolensk, Russia

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Tomsk, Russia

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Tver', Russia

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Tyumen, Russia

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Vladimir, Russia

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Vladivostok, Russia

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Volzhskiy, Russia

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Yaroslavl, Russia

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Yekaterinburg, Russia

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Belgrade, Serbia

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Kragujevac, Serbia

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Niš, Serbia

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Novi Sad, Serbia

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Chernivtsi, Ukraine

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Dnipro, Ukraine

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Ivano-Frankivsk, Ukraine

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Kharkiv, Ukraine

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Kiev, Ukraine

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Mykolaiv, Ukraine

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Ternopil, Ukraine

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Uzhhorod, Ukraine

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Zaporizhya, Ukraine

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Zhytomyr, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 40576086 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia; Dyslipidemias

Interventions

cholebine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Professor

  Information at Mitsubishi Pharma Europe

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: December 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 8, 2026
• Results First Posted: October 6, 2014

Record last verified: 2025-12

Locations

HU (7); RU (29); IT (4); UA (10); NO (1); PL (7); SE (4); MY (11)