Clinical trial NCT00451295: A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Keywords: Chronic Kidney Disease
Dialysis
Hyperphosphatemia
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2007-03-23
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Serum phosphorus change compared to placebo from baseline to week 12.
timeFrame: 12 weeks
Secondary outcomes:
measure: Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Frydek-Mistek
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Bordeaux
country: France
city: Montpelier
country: France
city: Aachen
country: Germany
city: Coburg
country: Germany
city: Lecco
country: Italy
city: Milan
country: Italy
city: Pavia
country: Italy
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Oswiecim
country: Poland
city: Poznan
country: Poland
city: Wejherowo
country: Poland
city: Wroclaw
country: Poland
city: Belgrade
country: Serbia
city: Nis
country: Serbia
city: Novisad
country: Serbia
city: Cape Town
country: South Africa
city: Gauteng
country: South Africa
city: Barcelona
country: Spain
city: Oviedo
country: Spain
city: Stevenage
country: United Kingdom
Study officials:
affiliation: Information at Mitsubishi Pharma Europe
name: Professor
role: PRINCIPAL_INVESTIGATOR
References: