A Phase III, Multicentre, Double-Blind, Placebo-Controlled Withdrawal Study in Patients With Hyperphosphatemia
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| ClinicalTrials.gov Identifier: NCT00416520 |
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Recruitment Status :
Completed
First Posted : December 28, 2006
Results First Posted : October 23, 2014
Last Update Posted : November 4, 2014
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Sponsor:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Kidney Disease Hyperphosphatemia | Drug: MCI-196 (Colestilan(INN), Colestimide(JAN), CHOLEBINE®) Drug: Placebo Drug: Another phosphate binder (Sevelamer) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 336 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | June 2007 |
| Actual Primary Completion Date : | November 2009 |
| Actual Study Completion Date : | November 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Kidney Diseases
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
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 Comparator: 2 |
Drug: Placebo
3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind |
| Active Comparator: 3 |
Drug: Another phosphate binder (Sevelamer)
Current approved dosing recommendations for 12 weeks |
Primary Outcome Measures :
- Change in Serum Phosphorus Levels From Week 12 to Week 16 (LOCF) (ITT2) [ Time Frame: week16 minus week12 ]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.
Secondary Outcome Measures :
- Change in Serum Phosphorus Levels From Baseline to Week 12 (LOCF) (ITT1) [ Time Frame: week12 minus week0 ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416520
Locations
Show 68 study locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
| Principal Investigator: | Professor | Information at Mitsubishi Pharma Europe |
| Responsible Party: | Mitsubishi Tanabe Pharma Corporation |
| ClinicalTrials.gov Identifier: | NCT00416520 |
| Other Study ID Numbers: |
MCI-196-E07 |
| First Posted: | December 28, 2006 Key Record Dates |
| Results First Posted: | October 23, 2014 |
| Last Update Posted: | November 4, 2014 |
| Last Verified: | October 2014 |
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
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Chronic Kidney Disease Dialysis Hyperphosphatemia Phosphate binder |
Additional relevant MeSH terms:
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Kidney Diseases Renal Insufficiency, Chronic Hyperphosphatemia Urologic Diseases Renal Insufficiency Phosphorus Metabolism Disorders |
Metabolic Diseases Sevelamer Chelating Agents Sequestering Agents Molecular Mechanisms of Pharmacological Action |