A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
This study has been terminated.
(This study was stopped because of insufficient enrollment.)
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00451295
First received: March 22, 2007
Last updated: November 13, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Kidney Disease Dialysis Hyperphosphatemia |
Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Mitsubishi Tanabe Pharma Corporation:
Primary Outcome Measures:
- Serum phosphorus change compared to placebo from baseline to week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 6 |
| Study Start Date: | May 2007 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
|
| Experimental: 2 |
Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)
3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female, 18 to 80 years of age.
- Stable phosphate control using Calcium-based phosphate-binding medication only.
- The subject is undergoing regular dialysis treatment.
- On a stabilised phosphorus diet.
- 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.
- 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.
- Current or a history of significant gastrointestinal motility problems
- A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.
- A history of substance or alcohol abuse within the last year.
- Seizure disorders.
- Using phosphate binder medication other than calcium based phosphate binders
- Using colestyramine, colestipol or colesevelam
- A history of drug or other allergy
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00451295
Locations
| Czech Republic | |
| Frydek-Mistek, Czech Republic | |
| Ostrava, Czech Republic | |
| France | |
| Bordeaux, France | |
| Montpelier, France | |
| Germany | |
| Aachen, Germany | |
| Coburg, Germany | |
| Italy | |
| Lecco, Italy | |
| Milan, Italy | |
| Pavia, Italy | |
| Macedonia, The Former Yugoslav Republic of | |
| Skopje, Macedonia, The Former Yugoslav Republic of | |
| Poland | |
| Gdansk, Poland | |
| Krakow, Poland | |
| Lodz, Poland | |
| Oswiecim, Poland | |
| Poznan, Poland | |
| Wejherowo, Poland | |
| Wroclaw, Poland | |
| Serbia | |
| Belgrade, Serbia | |
| Nis, Serbia | |
| Novisad, Serbia | |
| South Africa | |
| Cape Town, South Africa | |
| Gauteng, South Africa | |
| Spain | |
| Barcelona, Spain | |
| Oviedo, Spain | |
| United Kingdom | |
| Stevenage, United Kingdom | |
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
| Principal Investigator: | Professor | Information at Mitsubishi Pharma Europe |
More Information
No publications provided
| Responsible Party: | Mitsubishi Tanabe Pharma Corporation |
| ClinicalTrials.gov Identifier: | NCT00451295 History of Changes |
| Other Study ID Numbers: | MCI-196-E09 |
| Study First Received: | March 22, 2007 |
| Last Updated: | November 13, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Czech Republic: State Institute for Drug Control Italy: Ethics Committee Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Germany: Federal Institute for Drugs and Medical Devices South Africa: Medicines Control Council Spain: Ministry of Health and Consumption |
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
|
Chronic Kidney Disease Dialysis Hyperphosphatemia |
Additional relevant MeSH terms:
|
Kidney Diseases Hyperphosphatemia Renal Insufficiency, Chronic Kidney Failure, Chronic |
Urologic Diseases Phosphorus Metabolism Disorders Metabolic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on June 17, 2013