Phase 3
N=116
Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Chronic Kidney Disease · Dialysis · Hyperphosphatemia
Bottom Line
View on ClinicalTrials.gov: NCT00772382 ↗Enrolled (actual)
116
Serious AEs
54.3%
Results posted
May 2014
Primary outcome: Primary: Number of Adverse Events (AE) — 109; 50; 63 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MCI-196 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events (AE) |
109; 50; 63 | — |
| SECONDARY The Change in Serum Phosphorus From Baseline to Week 52 |
-1.18 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00772382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.