A Phase III, Randomised, Double-blind, Multi-centre, Withdrawal Study comparing MCI-196 versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis with Hyperphosphataemia (Incorporating a Randomised 12 Week Open-label Dose Titration Period with MCI-196 or Sevelamer)

Mitsubishi Tanabe Pharma Corporation0 sites320 target enrollmentNovember 21, 2006

Overview

No summary available.

Registry

who.int

Start Date

November 21, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. The subject is capable of reading and comprehending the informed consent and complying with study procedures and provides written informed consent.
•2\. The subject is male or female and 18 years of age or over.
•3\. The subject has a diagnosis of CKD (Stage V) as defined by the K/DOQI Guidelines and is on dialysis.
•4\. The subject is clinically stable on haemodialysis or peritoneal dialysis for at least 3 months, as judged by the Investigator.
•5\. The subject has stable phosphate control (as judged by the investigator) using phosphate\-binding medication for at least 1 month prior to the screening visit.
•6\. The subject is on a stabilised phosphorus diet, as considered appropriate by the physician.
•7\. The subject is undergoing regular dialysis treatment:
•\- If the subject is on haemodialysis, this is scheduled 3 times per week in a hospital or centre setting. The duration must be between 3 to 5 hours or if high\-flux dialysis a minimum of 2\.5 hours, depending on the standard of care in each centre.
•\- If the subject is on peritoneal dialysis, this is either daily APD (Automated Peritoneal Dialysis) or CAPD (Continuous Ambulatory Peritoneal Dialysis), the latter employing at least 3 bag changes per day.
•8\. The subject has serum phosphorus level, as measured by the Central Laboratory, less than 2\.42 mmol/L (7\.5 mg/dL) at screening.

•1\. The subject has 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.
•2\. The subject has a serum albumin level \<30\.0 g/L.
•3\. The subject has a history of PTH levels consistently/frequently \>1000 pg/mL.
•4\. The subject has a body mass index (BMI) \=16\.0 kg/m2 or \=40\.0 kg/m2\.
•5\. The subject has currently or has a history of significant gastrointestinal (GI) motility problems, including dysphagia or swallowing difficulty, or GI abnormalities such as chronic or severe constipation, sigmoid colitis, ulcers, or major GI surgery.
•6\. The subject has biliary obstruction or proven liver dysfunction, i.e., cirrhosis, hepatorenal syndrome, or has liver function tests 3 times the normal values for at least 2 of the measurements (ALT, AST, alkaline phosphatase, and gamma\-glutamyl\-transferase).
•7\. The subject is known to have a positive test for HIV 1 and 2 antibodies.
•8\. The subject has a history of clinically significant severe lactose intolerance or sensitivity (the placebo tablets have a high lactose content), as judged by the investigator.
•9\. The subject has a history of substance or alcohol abuse within the last year.
•10\. The subject has seizure disorders.