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

NCT ID: NCT00506441

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-09-30

Brief 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.

Conditions

Chronic Kidney Disease; Dialysis; Hyperphosphatemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

MCI-196

Intervention Type: DRUG

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

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

Interventions

MCI-196

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

Intervention Type: DRUG

Placebo

3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

Intervention Type: DRUG

Other Intervention Names

Colestilan(INN); Colestimide(JAN); CHOLEBINE®; BindRen®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanabe Pharma Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Professor

Role: PRINCIPAL_INVESTIGATOR

Information at Mitsubishi Pharma America

Locations

Glendale, Arizona, United States

Tempe, Arizona, United States

Hot Springs, Arkansas, United States

Paragould, Arkansas, United States

Pine Bluff, Arkansas, United States

Fountain Valley, California, United States

La Mesa, California, United States

Long Beach, California, United States

Lynwood, California, United States

Orange, California, United States

San Diego, California, United States

Whittier, California, United States

Brandon, Florida, United States

Hudson, Florida, United States

Lauderdale Lakes, Florida, United States

Tampa, Florida, United States

Augusta, Georgia, United States

Decatur, Georgia, United States

Macon, Georgia, United States

Evanston, Illinois, United States

Evergreen Park, Illinois, United States

Fort Wayne, Indiana, United States

Shreveport, Louisiana, United States

Springfield, Massachusetts, United States

Eatontown, New Jersey, United States

Flushing, New York, United States

Springfield Gardens, New York, United States

Allentown, Pennsylvania, United States

Lewistown, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Columbia, South Carolina, United States

Orangeburg, South Carolina, United States

Sumter, South Carolina, United States

San Antonio, Texas, United States

Alexandria, Virginia, United States

Portsmouth, Virginia, United States

Richmond, Virginia, United States

West Allis, Wisconsin, United States

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type: DERIVED

PMID: 40576086 (View on PubMed)

Hertel J, Locatelli F, Spasovski G, Dimkovic N, Wanner C. Randomized, Double-Blind, Placebo-Controlled, Withdrawal Study of Colestilan after Dose Titration in Chronic Kidney Disease Dialysis Patients with Hyperphosphatemia. Nephron. 2015;130(4):229-38. doi: 10.1159/000431289. Epub 2015 Jul 10.

Reference Type: DERIVED

PMID: 26184491 (View on PubMed)

Other Identifiers

MCI-196-A05

Identifier Type: -

Identifier Source: org_study_id