Clinical trial NCT00542386: A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia
Official title: A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Dyslipidemia
Keywords: Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Dyslipidemia
Phosphate binder
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2007-10-11
Enrollment: 642
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

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.
* 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

Primary outcomes:
measure: The Change in Serum Phosphorus
timeFrame: 12 weeks
measure: The Change in LDL-cholesterol
timeFrame: 12 weeks
Secondary outcomes:
measure: The Change in Total-cholesterol
timeFrame: 12 weeks
measure: The Change in HDL-cholesterol
timeFrame: 12 weeks
measure: The Change in Triglycerides
timeFrame: 12 weeks
measure: The Change in PTH
timeFrame: 12 weeks
measure: The Change in Ca
timeFrame: 12 weeks
measure: The Change in Ca x P Ion Product
timeFrame: 12 weeks
measure: The Incidence of Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
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: Lecco
country: Italy
city: Modena
country: Italy
city: Pavia
country: Italy
city: Roma
country: Italy
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
city: Alor Star
country: Malaysia
city: Ipoh
country: Malaysia
city: Kajang
country: Malaysia
city: Klang
country: Malaysia
city: Kota Kinabalu
country: Malaysia
city: Kuala Terengganu
country: Malaysia
city: Kuantan
country: Malaysia
city: Kuching
country: Malaysia
city: Melaka
country: Malaysia
city: Seremban
country: Malaysia
city: Taiping
country: Malaysia
city: Lodz
country: Poland
city: Plock
country: Poland
city: Poznan
country: Poland
city: Rybnik
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Zielona Gora
country: Poland
city: Arkhangelsk
country: Russian Federation
city: Armavir
country: Russian Federation
city: Chelyabinsk
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: 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: 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: Smolensk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tumen
country: Russian Federation
city: Tver
country: Russian Federation
city: Vladimir
country: Russian Federation
city: Vladivostok
country: Russian Federation
city: Volzhskiy
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: Chernivtsi
country: Ukraine
city: Dnepropetrovsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Mykolaiv
country: Ukraine
city: Ternopil
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Zaporizhya
country: Ukraine
city: Zhytomyr
country: Ukraine
Study officials:
affiliation: Information at Mitsubishi Pharma Europe
name: Professor
role: PRINCIPAL_INVESTIGATOR
References: