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

Purpose

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.

Condition	Intervention	Phase
Chronic Kidney Disease Dialysis Hyperphosphatemia Dyslipidemia	Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Chronic Kidney Disease Dialysis

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

The change in serum phosphorus for MCI-196 and placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The change in LDL-cholesterol for MCI-196 and placebo [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The change in Total-cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The change in HDL-cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The change in Triglycerides [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The change in PTH [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The change in Ca [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The change in Ca x P ion product [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The incidence of adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	642
Study Start Date:	December 2007
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) 3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
Placebo Comparator: 2	Drug: Placebo 3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542386

Show 73 Study Locations

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

Principal Investigator:

Professor

Information at Mitsubishi Pharma Europe

More Information

No publications provided

Responsible Party:	Study Project Manager, Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00542386 History of Changes
Other Study ID Numbers:	MCI-196-E08
Study First Received:	October 10, 2007
Last Updated:	June 27, 2010
Health Authority:	United States: Food and Drug Administration Italy: Ethics Committee Russia: Ministry of Health of the Russian Federation Macedonia: Ministry of Health Serbia and Montenegro: Agency for Drugs and Medicinal Devices Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Ukraine: State Pharmacological Center - Ministry of Health Hungary: National Institute of Pharmacy Malaysia: Ministry of Health

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Dyslipidemia
Phosphate binder

Additional relevant MeSH terms:

Kidney Diseases
Hyperphosphatemia
Dyslipidemias
Renal Insufficiency, Chronic
Kidney Failure, Chronic

Urologic Diseases
Phosphorus Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Renal Insufficiency

ClinicalTrials.gov processed this record on May 19, 2013