A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

NCT00416520 | Completed Phase 3 Results

• 1 other identifier: MCI-196-E07
• Study Type: interventional
• Target: 336
• Locations: 10 countries
• Sites: 62

Brief Summary

This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Conditions

Chronic Kidney Disease; Hyperphosphatemia

Keywords

Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Phosphate binder

Outcome Measures

Primary Outcomes (1)

• Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)

  ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.

  week16 minus week12

Secondary Outcomes (1)

• Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)

  week12 minus week0

Study Arms (3)

1

EXPERIMENTAL

Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)

2

PLACEBO COMPARATOR

Drug: Placebo

3

ACTIVE COMPARATOR

Drug: Another phosphate binder (Sevelamer)

Interventions

MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) DRUG

3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose and 4 weeks of double blind

1

Placebo DRUG

3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

2

Another phosphate binder (Sevelamer) DRUG

Current approved dosing recommendations for 12 weeks

3

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:

• Body Mass Index (BMI) \<=16.0 kg/m2 or \>=40.0 kg/m2
• A current or 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 (68)

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Adelaide, Australia

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Nedlands, Australia

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Parkville, Australia

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St Leonards, Australia

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Sydney, Australia

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Woolloongabba, Australia

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Graz, Austria

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Frýdek-Místek, Czechia

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HradecKralove, Czechia

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Ostrava, Czechia

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Prague, Czechia

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Tábor, Czechia

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Ústí nad Labem, Czechia

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Bordeaux, France

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Montpelier, France

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Paris, France

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Aachen, Germany

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Aschaffenburg, Germany

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Coburg, Germany

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Coesfeld, Germany

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Darmstadt, Germany

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Dieburg, Germany

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Dortmund, Germany

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Düsseldorf, Germany

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Hamburg, Germany

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Homberg (Efze), Germany

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Langen, Germany

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Mannheim-Kafertal, Germany

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München, Germany

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Potsdam-Babelsberg, Germany

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Baja, Hungary

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Budapest, Hungary

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Kisvárda, Hungary

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Veszprém, Hungary

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Biella, Italy

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Como, Italy

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Cremona, Italy

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Lecco, Italy

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Livorno, Italy

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Milan, Italy

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Pavia, Italy

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Perugia, Italy

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Rome, Italy

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Ciechanów, Poland

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Częstochowa, Poland

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Gdansk, Poland

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Krakow, Poland

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Lodz, Poland

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Lublin, Poland

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Oświęcim, Poland

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Pabianice, Poland

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Rybnik, Poland

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Sokołów Podlaski, Poland

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Starogard Gdański, Poland

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Warsaw, Poland

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Wejherowo, Poland

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Zgierz, Poland

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Zielona Góra, Poland

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Cape Town, South Africa

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Durban, South Africa

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Gauteng, South Africa

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Johannesburg, South Africa

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Port Elizabeth, South Africa

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Barcelona, Spain

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Oviedo, Spain

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Seville, Spain

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Glasgow, United Kingdom

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Stevenage, United Kingdom

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

Interventions

cholebine; Sevelamer

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

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

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: December 27, 2006
• First Posted: December 28, 2006
• Study Start: June 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 8, 2026
• Results First Posted: October 23, 2014

Record last verified: 2025-12

Locations

DE (14); HU (4); ZA (5); ES (3); AU (1); PL (15); GB (2); CZ (6); FR (3); IT (9)