A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Chronic Kidney Disease Clinical Trial

Official title:

A Phase III, Multicentre, Open Label, Flexible Dose, Long Term Safety Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542815
• Other study ID #: MCI-196-E10
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2007
• Last updated: September 24, 2014
• Start date: November 2007
• Est. completion date: August 2010

Study information

• Verified date: September 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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

Description:

Following completion of one of the Phase III studies (E07, E08 or E09) eligible patients will receive either MCI-196 for up to 52 weeks. The study is in two periods. The initial period allows flexible dosing for a period of 8 weeks. This will allow subjects to achieve individually optimised doses. After 8 weeks, subjects will continue flexible dosing with MCI-196 but with titration intervals every 4 weeks instead of every 2 weeks. Subjects previously exposed to MCI-196 will end the study at Week 40.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 632
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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) <= 16.0 kg/m2 or =>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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• MCI-196
3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose
• Another Phosphate binder (Sevelamer)
Current approved dosing recommendations for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Austria,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Macedonia, The Former Yugoslav Republic of,  Malaysia,  Poland,  Russian Federation,  Serbia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in Serum Phosphorus for MCI-196 and Sevelamer	Change from Baseline to Week 52 (LOCF)	52 weeks (Baseline-52 weeks)	No
Secondary	The Percent Change in Serum LDL-cholesterol for MCI-196 and Sevelamer	Percent Change from Baseline to Week 52 (LOCF)	52 weeks (Baseline-52 weeks)	No