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

Sponsored by:	Mitsubishi Tanabe Pharma Corporation
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00542815

Purpose

This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07, E08 and E09 studies will allow exposure to MCI-196 for up to 52 weeks

Condition	Intervention	Phase
Chronic Kidney Disease Dialysis Hyperphosphatemia	Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) Drug: Another Phosphate binder	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

The long-term safety and tolerability profile of MCI-196 in subjects with CKD on dialysis with hyperphosphatemia [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The long-term efficacy and safety, with regard to both hyperphosphatemia and dyslipidemia, of MCI-196. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	November 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) 3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
2: Active Comparator	Drug: Another Phosphate binder Current approved dosing recommendations for 12 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542815

Contacts

Contact: Information at Mitsubishi Pharama Europe

information@mitsubishi-pharma.eu

Locations

Czech Republic
	Recruiting
Frydek-Mistek, Czech Republic
Hungary
	Recruiting
Budapest, Hungary
	Recruiting
Baja, Hungary
Italy
	Recruiting
Lecco, Italy
	Recruiting
Milan, Italy
	Recruiting
Pavia, Italy
	Recruiting
Cremona, Italy
Macedonia, The Former Yugoslav Republic of
	Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of
Poland
	Recruiting
Lodz, Poland
	Recruiting
Oswiecim, Poland
	Recruiting
Rybnik, Poland
	Recruiting
Gdansk, Poland

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

Principal Investigator:

Professor

Information at Mitsubishi Pharma Europe

More Information

Responsible Party:	Mitsubishi Tanabe Pharma Corporation ( Study Project Manager )
Study ID Numbers:	MCI-196-E10
Study First Received:	October 10, 2007
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00542815
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; Italy: Ethics Committee; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Chronic Kidney Disease
Dialysis
Hyperphosphatemia

Study placed in the following topic categories:

Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic

Hyperphosphatemia
Kidney Diseases
Metabolic disorder
Kidney Failure

Additional relevant MeSH terms:

Phosphorus Metabolism Disorders

ClinicalTrials.gov processed this record on January 15, 2009