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A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

Primary Purpose

Chronic Kidney Disease, Dialysis, Hyperphosphatemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MCI-196
Placebo
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, Dyslipidemia, Phosphate binder

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

The Change in Serum Phosphorus
The change from baseline to week 12
The Change in LDL-cholesterol
The percentage change from baseline to week 12

Secondary Outcome Measures

The Change in Total-cholesterol
The Change in HDL-cholesterol
The Change in Triglycerides
The Change in PTH
The Change in Ca
The Change in Ca x P Ion Product
The Incidence of Adverse Events

Full Information

First Posted
October 10, 2007
Last Updated
September 30, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00542386
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
642 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo 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, 12 weeks of fixed dose of study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
Primary Outcome Measure Information:
Title
The Change in Serum Phosphorus
Description
The change from baseline to week 12
Time Frame
12 weeks
Title
The Change in LDL-cholesterol
Description
The percentage change from baseline to week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The Change in Total-cholesterol
Time Frame
12 weeks
Title
The Change in HDL-cholesterol
Time Frame
12 weeks
Title
The Change in Triglycerides
Time Frame
12 weeks
Title
The Change in PTH
Time Frame
12 weeks
Title
The Change in Ca
Time Frame
12 weeks
Title
The Change in Ca x P Ion Product
Time Frame
12 weeks
Title
The Incidence of Adverse Events
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
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

12. IPD Sharing Statement

Learn more about this trial

A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

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