Hyperphosphataemia and dyslipidaemia MedDRA version: 9.1 Level: LLT Classification code 10020711 Term: Hyperphosphataemia MedDRA version: 9.1 Level: LLT Classification code 10058108 Term: Dyslipidaemia
Conditions
Sponsors
Mitsubishi Tanabe Pharma Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject is capable of reading and comprehending the informed consent and complying with study procedures, and provides written informed consent. 2. The subject is male or female, and 18 years of age or over. 3. The subject has a diagnosis of Chronic Kidney Disease (Stage V) as defined by the K/DOQI Guidelines (i.e. GFR =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject has 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. 2. The subject has a serum albumin level 1000pg/mL 4. The subject has a body mass index (BMI) =16.0 kg/m2 or >40.0 kg/m2. 5. The subject has serum LDL-C level > 4.94mmol/L (190 mg/dL) 6. The subject has serum triglycerides level > 6.76 mmol/L (600 mg/dL) 7. The subject has currently or a history of significant gastrointestinal (GI) motility problems, including dysphagia or swallowing difficulty, or GI abnormalities such as chronic or severe constipation, sigmoid colitis, ulcers, or major GI surgery. 8. The subject has biliary obstruction or proven liver dysfunction, i.e., cirrhosis, hepatorenal syndrome, or has liver function tests 3 times the normal values for at least 2 of the measurements (ALT, AST, alkaline phosphatase, and gamma-glutamyl-transferase). 9. The subject is known to have a positive test for HIV 1 and 2 antibodies. 10. The subject has a history of clinically significant severe lactose intolerance or sensitivity (the placebo tablets have a high lactose content), as judged by the Investigator. 11. The subject has a history of substance or alcohol abuse within the last year. 12. The subject has seizure disorders. 13. The subject has a history of drug or other allergy that contraindicates their participation. 14. The subject is using any of the following drugs: - over-the-counter products containing calcium, magnesium and aluminium, and/or nutritional supplements which can not be stopped during the study period 15. The subject has a temporary catheter as a vascular access and is showing active signs of inflammation as a result of this. 16. The subject has participated in a clinical study with any experimental medication in the last 30 days, or an experimental biological product within the last 90 days, days prior to signing of informed consent. 17. The subject has had prior exposure to MCI-196 in the past 12 months. 18. If on peritoneal dialysis, the subject has a recent history of peritonitis (within the previous 3 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of a range of fixed doses of MCI-196 compared to placebo in the control of serum phosphorus and serum LDL-C in subjects with Chronic Kidney Disease Stage V on dialysis.;Secondary Objective: To include evaluation of further efficacy comparisons of a range of fixed doses of MCI-196 compared to placebo with regard to both hyperphosphataemia and dyslipidaemia. The safety and tolerability of MCI-196 compared to placebo will also be evaluated. ;Primary end point(s): The primary efficacy analyses will evaluate the change from Baseline to endpoint in serum phosphorus and the percent change from Baseline to endpoint in serum LDL-C .The primary endpoint is Week 12 or Last Observation Carried Forward (LOCF). | — |
Countries
Hungary, Italy
Outcome results
None listed