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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Dialysis; Hyperphosphatemia

Treatments: Drug: MCI-196

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772382

MCI-196-A06

Details and patient eligibility

About

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.

Enrollment: 116 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 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

MCI-196

Experimental group

Treatment:

Drug: MCI-196