Status:
TERMINATED
A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Chronic Kidney Disease
Dialysis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MC...
Eligibility Criteria
Inclusion
- Male or female, 18 to 80 years of age.
- Stable phosphate control using Calcium-based phosphate-binding medication only.
- The subject is undergoing regular dialysis treatment.
- On a stabilised phosphorus diet.
- 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.
- Male subjects must agree to use appropriate contraception.
Exclusion
- 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.
- Body mass index (BMI) \<=16.0 kg/m2 or =\>40.0 kg/m2.
- Current or a history of significant gastrointestinal motility problems
- A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
- A history of substance or alcohol abuse within the last year.
- Seizure disorders.
- Using phosphate binder medication other than calcium based phosphate binders
- Using colestyramine, colestipol or colesevelam
- A history of drug or other allergy
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00451295
Start Date
May 1 2007
End Date
January 1 2011
Last Update
November 15 2011
Active Locations (25)
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1
Frýdek-Místek, Czechia
2
Ostrava, Czechia
3
Bordeaux, France
4
Montpelier, France