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

NCT00506441 | Completed Phase 3 Results

• 1 other identifier: MCI-196-A05
• Study Type: interventional
• Target: 245
• Locations: 2 countries
• Sites: 39

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

Keywords

Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Phosphate binder

Outcome Measures

Primary Outcomes (1)

• The Change in Serum Phosphorus From Week 12 to Week 16

  The changes in serum phosphorus (mg/dL) from Week 12 to Week 16 (last observation post Week 12)

  4 weeks (Week 12 to Week 16)

Secondary Outcomes (10)

• Change From Baseline in Serum Phosphorus

  12 weeks (Week 0 to Week 12)

• Change From Baseline in PTH

  12 weeks

• Change From Baseline in Calcium

  12 weeks

• Change From Baseline in Calcium x Phosphorus Ion Product

  12 weeks

• Change From Baseline in Total Cholesterol

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Drug: MCI-196

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

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

2

MCI-196 DRUG

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

Also known as: Colestilan(INN), Colestimide(JAN), CHOLEBINE®, BindRen®

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (39)

Unknown Facility

Glendale, Arizona, United States

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Tempe, Arizona, United States

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Hot Springs, Arkansas, United States

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Paragould, Arkansas, United States

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Pine Bluff, Arkansas, United States

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Fountain Valley, California, United States

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La Mesa, California, United States

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Long Beach, California, United States

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Lynwood, California, United States

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Orange, California, United States

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San Diego, California, United States

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Whittier, California, United States

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Brandon, Florida, United States

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Hudson, Florida, United States

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Lauderdale Lakes, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Macon, Georgia, United States

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Evanston, Illinois, United States

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Evergreen Park, Illinois, United States

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Fort Wayne, Indiana, United States

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Shreveport, Louisiana, United States

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Springfield, Massachusetts, United States

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Eatontown, New Jersey, United States

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Flushing, New York, United States

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Springfield Gardens, New York, United States

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Allentown, Pennsylvania, United States

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Lewistown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Columbia, South Carolina, United States

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Orangeburg, South Carolina, United States

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Sumter, South Carolina, United States

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San Antonio, Texas, United States

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Alexandria, Virginia, United States

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Portsmouth, Virginia, United States

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Richmond, Virginia, United States

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West Allis, Wisconsin, United States

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San Juan, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 40576086 DERIVED

• 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.

  PMID: 26184491 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia

Interventions

cholebine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Professor

  Information at Mitsubishi Pharma America

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 25, 2007
• Study Start: September 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 8, 2026
• Results First Posted: July 25, 2014

Record last verified: 2025-12

Locations

PR (1); US (38)