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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Dialysis; Hyperphosphatemia

Treatments: Drug: Placebo; Drug: MCI-196

Study type: Interventional

Funder types: Industry

Identifiers

NCT00506441

MCI-196-A05

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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245 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: MCI-196

2

Placebo Comparator group

Treatment:

Drug: Placebo