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

Chronic Kidney Disease Clinical Trial

Official title:

A Phase III, Randomised, Double-Blind, Multi-centre, Withdrawal Study Comparing MCI-196 Versus Placebo in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416520
• Other study ID #: MCI-196-E07
• Status: Completed
• Phase: Phase 3
• First received: December 27, 2006
• Last updated: October 28, 2014
• Start date: June 2007
• Est. completion date: November 2009

Study information

• Verified date: October 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: Ethics CommitteeAustria: Agency for Health and Food SafetyCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSouth Africa: Medicines Control CouncilSpain: Ministry of Health and Consumption
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• 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 and 4 weeks of double blind
• Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind
• Another phosphate binder (Sevelamer)
Current approved dosing recommendations for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Australia,  Austria,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2)	ITT2 population included all re-randomised subjects who completed 12 weeks in the MCI-196 treatment group and received at least 1 dose of study medication in the placebo-controlled withdrawal period and had at least 1 central serum phosphorus value after 12 weeks.	week16 minus week12	No
Secondary	Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1)	ITT1 population included all subjects who received a randomisation number (at Week 0), took at least 1 dose of study medication and had at least 1 central serum phosphorus value after the start of study medication.	week12 minus week0	No