A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

Chronic Kidney Disease Clinical Trial

Official title:

A Phase III, Multi-centre, Double-blind, Randomised, Placebo-controlled Multiple Fixed-dose Study of MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (Incorporating Two Parallel High Dose Groups)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542386
• Other study ID #: MCI-196-E08
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2007
• Last updated: September 30, 2014
• Start date: December 2007
• Est. completion date: November 2009

Study information

• Verified date: September 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationItaly: Ethics CommitteeRussia: Ministry of Health of the Russian FederationMacedonia: Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUkraine: State Pharmacological Center - Ministry of HealthHungary: National Institute of PharmacyMalaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 642
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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<30.0g/L

• A PTH level >1000pg/mL

• A body mass index (BMI)<= 16.0kg/? or =>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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Dialysis
• Dyslipidemia
• Dyslipidemias
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• MCI-196
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study
• Placebo
3g to 15g/day (3 times a day), Tablet, 12 weeks of fixed dose of study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Hungary,  Italy,  Macedonia, The Former Yugoslav Republic of,  Malaysia,  Poland,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in Serum Phosphorus	The change from baseline to week 12	12 weeks	No
Primary	The Change in LDL-cholesterol	The percentage change from baseline to week 12	12 weeks	No
Secondary	The Change in Total-cholesterol		12 weeks	No
Secondary	The Change in HDL-cholesterol		12 weeks	No
Secondary	The Change in Triglycerides		12 weeks	No
Secondary	The Change in PTH		12 weeks	No
Secondary	The Change in Ca		12 weeks	No
Secondary	The Change in Ca x P Ion Product		12 weeks	No
Secondary	The Incidence of Adverse Events		12 weeks	Yes