A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
A Phase III, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
1 other identifier
interventional
632
15 countries
115
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2007
Typical duration for phase_3
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2007
CompletedFirst Posted
Study publicly available on registry
October 12, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
September 23, 2014
CompletedJanuary 7, 2026
December 1, 2025
2.8 years
October 10, 2007
September 16, 2014
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Change in Serum Phosphorus for MCI-196 and Sevelamer
Change from Baseline to Week 52 (LOCF)
52 weeks (Baseline-52 weeks)
Secondary Outcomes (1)
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
52 weeks (Baseline-52 weeks)
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (115)
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Graz, Austria
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Frýdek-Místek, Czechia
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Hradec Králové, 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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Aschaffenburg, Germany
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Coesfeld, Germany
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Darmstadt, 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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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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Veszprém, Hungary
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Ancona, Italy
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Cernusco sul Naviglio, 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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Modena, Italy
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Ostia Roma, Italy
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Pavia, Italy
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Perugia, Italy
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Rome, Italy
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Alor Star, 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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Kuching, Malaysia
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Malacca, Malaysia
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Selangor Darul Ehsan, Malaysia
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Seremban, Malaysia
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Taiping, Malaysia
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Skopje, North Macedonia
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Ciechanów, Poland
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Częstochowa, Poland
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Gdansk, 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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Poznan, 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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Wroclaw, Poland
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Zgierz, Poland
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Zielona Góra, Poland
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Arkhangelsk, 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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Karbysheva str.Volzskiy, 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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Mytishchi, 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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Rozhkova, Russia
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Saint Petersburg, Russia
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Smolensk, Russia
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Tomsk, Russia
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Vladivostok, 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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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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Chernivtsy, 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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Mykolayiv, 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
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Glasgow, United Kingdom
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Stevenage, United Kingdom
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: 40576086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials, Information Desk
- Organization
- Tanabe Pharma Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Professor
Information at Mitsubishi Pharma Europe
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2007
First Posted
October 12, 2007
Study Start
November 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
January 7, 2026
Results First Posted
September 23, 2014
Record last verified: 2025-12