Clinical trial NCT00416520: A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
Official title: A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Hyperphosphatemia
Keywords: Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Phosphate binder
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2006-12-28
Enrollment: 336
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 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.


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.
* 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

Primary outcomes:
measure: Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)
timeFrame: week16 minus week12
Secondary outcomes:
measure: Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)
timeFrame: week12 minus week0
Other outcomes:
Locations:
city: Adelaide
country: Australia
city: Nedlands
country: Australia
city: Parkville
country: Australia
city: St Leonards
country: Australia
city: Sydney
country: Australia
city: Woolloongabba
country: Australia
city: Graz
country: Austria
city: Frydek-Mistek
country: Czech Republic
city: HradecKralove
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: Aachen
country: Germany
city: Aschaffenburg
country: Germany
city: Coburg
country: Germany
city: Coesfeld
country: Germany
city: Darmstadt
country: Germany
city: Dieburg
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: Munchen
country: Germany
city: Potsdam-Babelsberg
country: Germany
city: Baja
country: Hungary
city: Budapest
country: Hungary
city: Kisvarda
country: Hungary
city: Veszprem
country: Hungary
city: Biella
country: Italy
city: Como
country: Italy
city: Cremona
country: Italy
city: Lecco
country: Italy
city: Livorno
country: Italy
city: Milan
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Rome
country: Italy
city: Ciechanow
country: Poland
city: Czestochowa
country: Poland
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Oswiecim
country: Poland
city: Pabianice
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: Zgierz
country: Poland
city: Zielona Gora
country: Poland
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: Glasgow
country: United Kingdom
city: Stevenage
country: United Kingdom
Study officials:
affiliation: Information at Mitsubishi Pharma Europe
name: Professor
role: PRINCIPAL_INVESTIGATOR
References: