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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.

The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Bile Acids and Salts

Criteria

Inclusion Criteria:

• Male or female, and is >=18 years old

• Stable hemodialysis or peritoneal dialysis

• Subjects have stable phosphate control

• Subjects on stabilized phosphorus diet

• Subjects undergoing regular dialysis treatment

• Females 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 him/her 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

• serum albumin level < 3.0g/L

• PTH level > 1000pg/mL

• Hemoglobin level < 8mg/dL

• A History of significant gastrointestinal motility problems

• Biliary obstruction or proven liver dysfunction

• 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

• using cholestyramine, colestipol or colesevelam

• Schedule to receive a kidney transplant within the next 6 months

• Participation 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