A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia

Chronic Kidney Disease Clinical Trial

Official title:

A Phase III, Double-Blind, Multi-Centre, Randomised, Parallel Group Design, Placebo-Controlled, Flexible Dose Study of MCI-196 in Combination With a Ca-Based Phosphate Binder in CKD Stage V Subjects on Dialysis With Hyperphosphatemia.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00451295
• Other study ID #: MCI-196-E09
• Status: Terminated
• Phase: Phase 3
• First received: March 22, 2007
• Last updated: November 13, 2011
• Start date: May 2007
• Est. completion date: January 2011

Study information

• Verified date: November 2011
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyCzech Republic: State Institute for Drug ControlItaly: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsGermany: Federal Institute for Drugs and Medical DevicesSouth Africa: Medicines Control CouncilSpain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial Summary

This study consists of a 4 week run-in period with a Ca based phosphate binder and 12 weeks treatment period by MCI-196 or placebo, (both on Ca based phosphate binder). During the treatment period, MCI-196 or placebo will be titrated every 3 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or female, 18 to 80 years of age.

2. Stable phosphate control using Calcium-based phosphate-binding medication only.

3. The subject is undergoing regular dialysis treatment.

4. On a stabilised phosphorus diet.

5. If female and of child-bearing potential, has a negative serum pregnancy test. Sexually active females must agree to take appropriate steps not to become pregnant.

6. Male subjects must agree to use appropriate contraception.

Exclusion Criteria:

1. 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.

2. Body mass index (BMI) <=16.0 kg/m2 or =>40.0 kg/m2.

3. Current or a history of significant gastrointestinal motility problems

4. A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.

5. A history of substance or alcohol abuse within the last year.

6. Seizure disorders.

7. Using phosphate binder medication other than calcium based phosphate binders

8. Using colestyramine, colestipol or colesevelam

9. A history of drug or other allergy

10. 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 the informed consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Dialysis
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
• Placebo
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Czech Republic,  France,  Germany,  Italy,  Macedonia, The Former Yugoslav Republic of,  Poland,  Serbia,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum phosphorus change compared to placebo from baseline to week 12.		12 weeks	No
Secondary	Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters.		12 weeks	Yes