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

NCT00772382 | Completed Phase 3 Results

• 1 other identifier: MCI-196-A06
• Study Type: interventional
• Target: 116
• Locations: 2 countries
• Sites: 21

Brief Summary

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.

Conditions

Chronic Kidney Disease; Dialysis; Hyperphosphatemia

Keywords

Chronic Kidney Disease; Dialysis; Hyperphosphatemia; Phosphate binder

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events (AE)

  52 weeks

Secondary Outcomes (1)

• The Change in Serum Phosphorus From Baseline to Week 52

  52 weeks

Study Arms (1)

MCI-196

EXPERIMENTAL

Drug: MCI-196

Interventions

MCI-196 DRUG

3g to 15g/day (3 times a day), Tablet, 52 weeks of flexible dose

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

MCI-196

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (21)

Unknown Facility

Los Angeles, California, United States

Location

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Orange, California, United States

Location

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Tarzana, California, United States

Location

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Orlando, Florida, United States

Location

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Pembroke Pines, Florida, United States

Location

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Atlanta, Georgia, United States

Location

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Gurnee, Illinois, United States

Location

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Evansville, Indiana, United States

Location

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Baton Rouge, Louisiana, United States

Location

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New Orleans, Louisiana, United States

Location

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Northport, New York, United States

Location

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Durham, North Carolina, United States

Location

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Oklahoma City, Oklahoma, United States

Location

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Nashville, Tennessee, United States

Location

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Houston, Texas, United States

Location

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Burlington, Vermont, United States

Location

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Chesapeake, Virginia, United States

Location

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Kamloops, British Columbia, Canada

Location

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London, Ontario, Canada

Location

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Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Related Publications (1)

• Locatelli F, Spasovski G, Dimkovic N, Wanner C. Long-Term Evaluation of Colestilan in Chronic Kidney Disease Stage 5 Dialysis Patients with Hyperphosphataemia. Blood Purif. 2016;41(4):247-53. doi: 10.1159/000441648. Epub 2015 Dec 16.

  PMID: 26670307 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2008
• First Posted: October 15, 2008
• Study Start: December 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 8, 2026
• Results First Posted: May 12, 2014

Record last verified: 2025-12

Locations

CA (4); US (17)