A Phase III, Multi-Centre, Randomised, Placebo-Controlled... | NCT00451295

Studies
A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia

NCT00451295

Sponsor

Tanabe Pharma Corporation

Status

Terminated

Last Update Posted

Nov 15, 2011Estimated

Enrollment

6Actual

Phase

Phase 3

Conditions

Chronic Kidney Disease
Dialysis
Hyperphosphatemia

Interventions

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

Countries

Czechia
France
Germany
Italy
North Macedonia
Poland
Serbia
South Africa
Spain
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This study was stopped because of insufficient enrollment.

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

Mar 22, 2007

First Submission Date that Met QC Criteria

Mar 22, 2007

First Posted Date

Mar 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2011

Last Update Posted Date

Nov 15, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator		Drug: Placebo
2	Experimental		Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)	Drug	3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum phosphorus change compared to placebo from baseline to week 12.		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters.		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

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
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Professor	Information at Mitsubishi Pharma Europe	Principal Investigator

ID	Term
D051436	Renal Insufficiency, Chronic
D054559	Hyperphosphatemia

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Facility	Status	City	State	ZIP	Country	Contacts
		Frýdek-Místek			Czechia