A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Hyperphosphatemia

Treatments: Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®); Drug: Another phosphate binder (Sevelamer); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00416520

MCI-196-E07

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, randomised, parallel group, flexible dose, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Enrollment: 336 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years of age or over
• Clinically stable haemodialysis or peritoneal dialysis
• Stable phosphate control
• On a stabilised phosphorus diet
• 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.
• Body Mass Index (BMI) <=16.0 kg/m2 or >=40.0 kg/m2
• A current or history of significant gastrointestinal motility problems
• 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
• A temporary catheter as a vascular access
• Participated 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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336 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)

2

Placebo Comparator group

Treatment:

Drug: Placebo

3

Active Comparator group

Treatment:

Drug: Another phosphate binder (Sevelamer)