Phase 3
N=632
A 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: NCT00542815 ↗Enrolled (actual)
632
Serious AEs
24.2%
Results posted
Sep 2014
Primary outcome: Primary: The Change in Serum Phosphorus for MCI-196 and Sevelamer — -1.23; -1.47; -2.26 mg / dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MCI-196 (Drug); Another Phosphate binder (Sevelamer) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Serum Phosphorus for MCI-196 and Sevelamer |
-1.23; -1.47; -2.26 | — |
| SECONDARY The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer |
-26.22; -30.62; -28.66 | — |
Summary
This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will allow exposure to MCI-196 for up to 52 weeks
Eligibility Criteria
Inclusion Criteria
- Clinically stable haemodialysis or peritoneal dialysis treatment.
- Stable phosphate control
- Stabilised phosphorus diet.
- female subjects of child-bearing potential must have a negative serum pregnancy test.
- Male subjects must agree to use appropriate contraception.
- Completed one of the MCI-196 PIII studies
Exclusion Criteria
- 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) 40.0 kg/m2.
- Current or a history of significant gastrointestinal motility problems
- Positive test for HIV 1 and 2 antibodies.
- History of substance or alcohol abuse within the last year.
- Seizure disorders.
- History of drug or other allergy.
- Temporary catheter with active signs of inflammation or infection.
- The subject has participated in a clinical study with any experimental medication (with the exception of MCI-196 PIII studies) in the last 30days or experimental biological product within the 90 days prior to signing of informed consent form.
Data sourced from ClinicalTrials.gov (NCT00542815). 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.