A Phase 3, Randomized, Double Blind, Placebo-Controlled, Multi-Center, Withdrawal Study of MCI-196 in CKD on Dialysis With Hyperphosphatemia

Chronic Kidney Disease Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in Stage V Subjects on Dialysis With Hyperphosphatemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506441
• Other study ID #: MCI-196-A05
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2007
• Last updated: September 5, 2014
• Start date: September 2007
• Est. completion date: September 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 Administration
• Study type: Interventional

Clinical Trial Summary

This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, and is >=18 years old

• Stable hemodialysis or peritoneal dialysis

• Subjects has Stable phosphate control

• Subjects on Stabilized phosphorus diet

• Subjects undergoing regular dialysis treatment

• 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.

• serum albumin level < 3.0g/dL

• 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 hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies

• A clinically significant severe lactose intolerance or sensitivity

• 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

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
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• MCI-196
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind
• Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in Serum Phosphorus From Week 12 to Week 16	The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)	4 weeks (Week 12 to Week 16)	No
Secondary	Change From Baseline in Serum Phosphorus		12 weeks (Week 0 to Week 12)	No
Secondary	Change From Baseline in PTH		12 weeks	No
Secondary	Change From Baseline in Calcium		12 weeks	No
Secondary	Change From Baseline in Calcium x Phosphorus Ion Product		12 weeks	No
Secondary	Change From Baseline in Total Cholesterol		12 weeks	No
Secondary	Change From Baseline in LDL Cholesterol		12 weeks	No
Secondary	Change From Baseline in HDL Cholesterol		12 weeks	No
Secondary	Change From Baseline in VLDL Cholesterol		12 weeks	No
Secondary	Change From Baseline in Triglyceride		12 weeks	No
Secondary	Incidence of Adverse Events		12 weeks (Week 0-12) and 4 weeks (Week 12-16)	Yes