Clinical trial NCT00542815: A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Keywords: Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2007-10-12
Enrollment: 632
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Change in Serum Phosphorus for MCI-196 and Sevelamer
timeFrame: 52 weeks (Baseline-52 weeks)
Secondary outcomes:
measure: The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
timeFrame: 52 weeks (Baseline-52 weeks)
Other outcomes:
Locations:
city: Graz
country: Austria
city: Frydek-Mistek
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Praha
country: Czech Republic
city: Tabor
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Bordeaux
country: France
city: Montpelier
country: France
city: Paris
country: France
city: Aschaffenburg
country: Germany
city: Coesfeld
country: Germany
city: Darmstadt
country: Germany
city: Dortmund
country: Germany
city: Dusseldorf
country: Germany
city: Hamburg
country: Germany
city: Homberg-Efze
country: Germany
city: Langen
country: Germany
city: Mannheim-Kafertal
country: Germany
city: Ajka
country: Hungary
city: Baja
country: Hungary
city: Budapest
country: Hungary
city: Esztergom
country: Hungary
city: Gyor
country: Hungary
city: Hatvan
country: Hungary
city: Kisvarda
country: Hungary
city: Veszprem
country: Hungary
city: Ancona
country: Italy
city: Cernusco sul Naviglio
country: Italy
city: Como
country: Italy
city: Cremona
country: Italy
city: Lecco
country: Italy
city: Livorno
country: Italy
city: Milan
country: Italy
city: Modena
country: Italy
city: Ostia Roma
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Rome
country: Italy
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
city: Alor Setar
country: Malaysia
city: Klang
country: Malaysia
city: Kota Kinabalu
country: Malaysia
city: Kuala Terengganu
country: Malaysia
city: Kuching
country: Malaysia
city: Melaka
country: Malaysia
city: Selangor Darul Ehsan
country: Malaysia
city: Seremban
country: Malaysia
city: Taiping
country: Malaysia
city: Ciechanow
country: Poland
city: Czestochowa
country: Poland
city: Gdansk
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Oswiecim
country: Poland
city: Pabianice
country: Poland
city: Poznan
country: Poland
city: Rybnik
country: Poland
city: Sokolow Podlaski
country: Poland
city: Starogard Gdanski
country: Poland
city: Warszawa
country: Poland
city: Wejherowo
country: Poland
city: Wroclaw
country: Poland
city: Zgierz
country: Poland
city: Zielona Gora
country: Poland
city: Arkhangelsk
country: Russian Federation
city: Chita
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Ivanovo
country: Russian Federation
city: Kaluga
country: Russian Federation
city: Karbysheva str.Volzskiy
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Khabarovsk
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Krasnoyarsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Mytishchi
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Novokuznetsk
country: Russian Federation
city: Novorossiysk
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Rostov-on-Don
country: Russian Federation
city: Rozhkova
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Vladivostok
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Nis
country: Serbia
city: Novi Sad
country: Serbia
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Gauteng
country: South Africa
city: Johannesburg
country: South Africa
city: Port Elizabeth
country: South Africa
city: Barcelona
country: Spain
city: Oviedo
country: Spain
city: Sevilla
country: Spain
city: Chernivtsy
country: Ukraine
city: Dnepropetrovsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Mykolayiv
country: Ukraine
city: Ternopil
country: Ukraine
city: Uzhorod
country: Ukraine
city: Zaporizhya
country: Ukraine
city: Zhytomyr
country: Ukraine
city: Glasgow
country: United Kingdom
city: Stevenage
country: United Kingdom
Study officials:
affiliation: Information at Mitsubishi Pharma Europe
name: Professor
role: PRINCIPAL_INVESTIGATOR
References: