NCT00451295

Brief Summary

This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2007

Typical duration for phase_3

Geographic Reach
10 countries

25 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

November 15, 2011

Status Verified

November 1, 2011

Enrollment Period

3.7 years

First QC Date

March 22, 2007

Last Update Submit

November 13, 2011

Conditions

Chronic Kidney DiseaseDialysisHyperphosphatemia

Keywords

Chronic Kidney DiseaseDialysisHyperphosphatemia

Outcome Measures

Primary Outcomes (1)

  • Serum phosphorus change compared to placebo from baseline to week 12.

    12 weeks

Secondary Outcomes (1)

  • Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters.

    12 weeks

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: Placebo

2

EXPERIMENTAL
Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)

Interventions

MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)DRUG

3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose

2
PlaceboDRUG

3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 to 80 years of age.
  • Stable phosphate control using Calcium-based phosphate-binding medication only.
  • The subject is undergoing regular dialysis treatment.
  • On a stabilised phosphorus diet.
  • If female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant.
  • Male subjects must agree to use appropriate contraception.

You may not qualify if:

  • Body mass index (BMI) \<=16.0 kg/m2 or =\>40.0 kg/m2.
  • Current or a history of significant gastrointestinal motility problems
  • A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
  • A history of substance or alcohol abuse within the last year.
  • Seizure disorders.
  • Using phosphate binder medication other than calcium based phosphate binders
  • Using colestyramine, colestipol or colesevelam
  • A history of drug or other allergy
  • 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 the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Unknown Facility

Frýdek-Místek, Czechia

Location

Unknown Facility

Ostrava, Czechia

Location

Unknown Facility

Bordeaux, France

Location

Unknown Facility

Montpelier, France

Location

Unknown Facility

Aachen, Germany

Location

Unknown Facility

Coburg, Germany

Location

Unknown Facility

Lecco, Italy

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Pavia, Italy

Location

Unknown Facility

Skopje, North Macedonia

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Oświęcim, Poland

Location

Unknown Facility

Poznan, Poland

Location

Unknown Facility

Wejherowo, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Belgrade, Serbia

Location

Unknown Facility

Niš, Serbia

Location

Unknown Facility

Novisad, Serbia

Location

Unknown Facility

Cape Town, South Africa

Location

Unknown Facility

Gauteng, South Africa

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Oviedo, Spain

Location

Unknown Facility

Stevenage, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicHyperphosphatemia

Interventions

cholebine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPhosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Professor

    Information at Mitsubishi Pharma Europe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2007

First Posted

March 23, 2007

Study Start

May 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 15, 2011

Record last verified: 2011-11

Locations

GB(1)CZ(2)PL(7)IT(3)FR(2)DE(2)SE(3)ES(2)NO(1)ZA(2)