Clareo Health | A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tanabe Pharma Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female, and is \>=18 years old
Stable hemodialysis or peritoneal dialysis
Subjects has Stable phosphate control
Subjects on Stabilized phosphorus diet
Subjects undergoing regular dialysis treatment
Female and of child-bearing potential have a negative serum pregnancy test.
Male subjects must agree to use appropriate contraception.
You may not be if
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.
serum albumin level \< 3.0g/dL
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 hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies
A clinically significant severe lactose intolerance or sensitivity
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
