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

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Conditions

Chronic Kidney Disease

Dialysis

Dyslipidemia

Hyperphosphatemia

Treatments

Drug: MCI-196

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00542386

MCI-196-E08

Details and patient eligibility

About

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.

Enrollment

642 patients

Sex

All

Ages

18+ years old

Volunteers

No 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