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
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Male or female, 18 to 80 years of age.
2. Stable phosphate control using Calcium-based phosphate-binding medication only.
3. The subject is undergoing regular dialysis treatment.
4. On a stabilised phosphorus diet.
5. If female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant.
6. Male subjects must agree to use appropriate contraception.
You may not be if
1. 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. Body mass index (BMI) \<=16.0 kg/m2 or =\>40.0 kg/m2.
3. Current or a history of significant gastrointestinal motility problems
4. A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
5. A history of substance or alcohol abuse within the last year.
6. Seizure disorders.
7. Using phosphate binder medication other than calcium based phosphate binders
8. Using colestyramine, colestipol or colesevelam
9. A history of drug or other allergy
10. 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 the informed consent.
Clareo Health | A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
