Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia (NCT00772382) | Clinical Trial Compass
CompletedPhase 3
Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
United States116 participantsStarted 2008-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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