Status:
COMPLETED
Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Chronic Kidney Disease
Dialysis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 seco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00772382
Start Date
December 1 2008
End Date
August 1 2010
Last Update
January 8 2026
Active Locations (21)
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1
Los Angeles, California, United States
2
Orange, California, United States
3
Tarzana, California, United States
4
Orlando, Florida, United States