Chronic Kidney Disease, Dialysis, Hyperphosphatemia
Conditions
Keywords
Chronic Kidney Disease, Dialysis, Hyperphosphatemia, Phosphate binder
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 secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.
Interventions
DRUGMCI-196
3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Adverse Events (AE) | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The Change in Serum Phosphorus From Baseline to Week 52 | 52 weeks |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MCI-196 3, 6, 9, 12, or 15 g/ day as titrated | 116 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 19 |
| Overall Study | Death | 6 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Other Reasons | 10 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | MCI-196 |
|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 13.8 |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 106 / 116 |
| serious Total, serious adverse events | 63 / 116 |
Outcome results
Primary
Number of Adverse Events (AE)
Time frame: 52 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MCI-196 | Number of Adverse Events (AE) | At least 1 treatment-emergent AE | 109 participants |
| MCI-196 | Number of Adverse Events (AE) | At least 1 drug-related treatment-emergent AE | 50 participants |
| MCI-196 | Number of Adverse Events (AE) | At least 1 treatment-emergent serious AE | 63 participants |
Secondary
The Change in Serum Phosphorus From Baseline to Week 52
Time frame: 52 weeks
Population: Intent-to-treat (ITT) with last observation carried forward (LOCF). (ITT population included all enrolled subjects who took at least one dose of study medication and had at least one post-enrollment efficacy value after the start of study medication.)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MCI-196 | The Change in Serum Phosphorus From Baseline to Week 52 | -1.18 mg/dL | 95% Confidence Interval 2.05 |