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 Pharma Corporation0 sites320 target enrollmentDecember 29, 2006

ConditionsHyperphosphataemia MedDRA version: 8.1Level: LLTClassification code 10020711Term: Hyperphosphataemia

DrugsCHOLEBINE®Renagel®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hyperphosphataemia
Sponsor: Mitsubishi Pharma Corporation
Enrollment: 320
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 29, 2006

End Date

November 11, 2009

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Mitsubishi Pharma Corporation

Eligibility Criteria

Inclusion Criteria

•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, 18 to 80 years of age.
•3\. The subject has a diagnosis of CKD (Stage V) as defined by the K/DOQI Guidelines (i.e. GFR \<15 mL/min/1\.73m2 or 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 3 months 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\.10 mmol/L (6\.5 mg/dL) at screening.

Exclusion Criteria

•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 PTH level \>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., hepatitis, 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 hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies. The subject is known to have a positive test for hepatitis C antibody with high transaminase levels (\>3 times the upper limit of normal) or PCR positive. Note: Subjects testing positive for Hep C antibody may be included into the study if, in the investigators opinion, there is no evidence of active disease present as confirmed by PCR.
•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.