Phase 3
Completed N=642
A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia
Source: ClinicalTrials.gov NCT00542386 ↗Enrolled (actual)
642
Serious AEs
4.1%
Results posted
Oct 2014
Primary outcomePrimary: The Change in Serum Phosphorus — -0.23; -0.77; -0.97; -0.71 mg/dL
Summary
This is a phase III multi-centre study in two periods: the first period is a phosphate binder and lipid lowering drugs washout for 8 weeks, the second period is a double-blind, randomised, parallel group, fixed dose, for 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Serum Phosphorus |
-0.23; -0.77; -0.97; -0.71; -1.41; -0.12 | — |
| PRIMARY The Change in LDL-cholesterol |
-16.66; -23.56; -27.64; -29.44; -27.46; 2.77 | — |
| SECONDARY The Change in Total-cholesterol |
— | — |
| SECONDARY The Change in HDL-cholesterol |
— | — |
| SECONDARY The Change in Triglycerides |
— | — |
| SECONDARY The Change in PTH |
— | — |
| SECONDARY The Change in Ca |
— | — |
| SECONDARY The Change in Ca x P Ion Product |
— | — |
| SECONDARY The Incidence of Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 years of age or over
- Clinically stable haemodialysis or peritoneal dialysis
- Stable phosphate control
- On a stabilised phosphorus diet
- Female 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 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.
- A a serum albumin level 1000pg/mL
- A body mass index (BMI) 40.0kg/㎡
- A serum LDL-C level >4.94mmol/L(190mg/dL)
- A serum triglycerides level >6.76mmol/L (600mg/dL)
- A History of significant gastrointestinal motility problems
- 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
- A temporary catheter as a vascular access
- Participated 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 (NCT00542386). 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. Informational only — not medical advice.