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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00416520
• Date of registration: 27/12/2006
• Prospective Registration: Yes
• Primary sponsor: Mitsubishi Tanabe Pharma Corporation
• Public title: A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
• Scientific 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
• Date of first enrolment: June 2007
• Target sample size: 336
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00416520
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Professor
• Affiliation: Information at Mitsubishi Pharma Europe

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Kidney Disease

Hyperphosphatemia

Intervention(s)

Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®)

Drug: Placebo

Drug: Another phosphate binder (Sevelamer)

Primary Outcome(s)

Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2) [Time Frame: week16 minus week12]

Secondary Outcome(s)

Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1) [Time Frame: week12 minus week0]

Secondary ID(s)

MCI-196-E07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/10/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00416520