search
Back to results

A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Primary Purpose

Chronic Kidney Disease, Dialysis, Hyperphosphatemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MCI-196
Another Phosphate binder (Sevelamer)
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, Dialysis, Hyperphosphatemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The Change in Serum Phosphorus for MCI-196 and Sevelamer
Change from Baseline to Week 52 (LOCF)

Secondary Outcome Measures

The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
Percent Change from Baseline to Week 52 (LOCF)

Full Information

First Posted
October 10, 2007
Last Updated
September 24, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00542815
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Dialysis, Hyperphosphatemia
Keywords
Chronic Kidney Disease, Dialysis, Hyperphosphatemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
632 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
MCI-196
Other Intervention Name(s)
Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®
Intervention Description
3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
Intervention Type
Drug
Intervention Name(s)
Another Phosphate binder (Sevelamer)
Intervention Description
Current approved dosing recommendations for 12 weeks
Primary Outcome Measure Information:
Title
The Change in Serum Phosphorus for MCI-196 and Sevelamer
Description
Change from Baseline to Week 52 (LOCF)
Time Frame
52 weeks (Baseline-52 weeks)
Secondary Outcome Measure Information:
Title
The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer
Description
Percent Change from Baseline to Week 52 (LOCF)
Time Frame
52 weeks (Baseline-52 weeks)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor
Organizational Affiliation
Information at Mitsubishi Pharma Europe
Official's Role
Principal Investigator
Facility Information:
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

12. IPD Sharing Statement

Learn more about this trial

A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

We'll reach out to this number within 24 hrs