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, Multi-center, 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: NCT00772382
• Other study ID #: MCI-196-A06
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2008
• Last updated: September 5, 2014
• Start date: December 2008
• 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 States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to demonstrate the long-term safety and tolerability of MCI-196 in the subjects with stage V chronic kidney disease on dialysis with hyperphosphatemia.

The secondary objective of this study is to assess the long-term efficacy of flexible doses of MCI-196.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• 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 have stable phosphate control

• Subjects on stabilized phosphorus diet

• Subjects undergoing regular dialysis treatment

• Females 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 him/her 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/L

• 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 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

• 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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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, 52 weeks of flexible dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events (AE)		52 weeks	Yes
Secondary	The Change in Serum Phosphorus From Baseline to Week 52		52 weeks	No