Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2025-12-27 @ 9:13 PM
Study NCT ID:
NCT00451295
Status:
TERMINATED
Last Update Posted:
2011-11-15
First Post:
2007-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D054559', 'term': 'Hyperphosphatemia'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106574', 'term': 'cholebine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'This study was stopped because of insufficient enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-13', 'studyFirstSubmitDate': '2007-03-22', 'studyFirstSubmitQcDate': '2007-03-22', 'lastUpdatePostDateStruct': {'date': '2011-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum phosphorus change compared to placebo from baseline to week 12.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Both Efficacy parameters (such as LDL-cholesterol, other lipid parameters, PTH, Ca, Ca x P ion product) and safety parameters.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'Dialysis', 'Hyperphosphatemia'], 'conditions': ['Chronic Kidney Disease', 'Dialysis', 'Hyperphosphatemia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 18 to 80 years of age.\n2. Stable phosphate control using Calcium-based phosphate-binding medication only.\n3. The subject is undergoing regular dialysis treatment.\n4. On a stabilised phosphorus diet.\n5. 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.\n6. Male subjects must agree to use appropriate contraception.\n\nExclusion Criteria:\n\n1. 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.\n2. Body mass index (BMI) \\<=16.0 kg/m2 or =\\>40.0 kg/m2.\n3. Current or a history of significant gastrointestinal motility problems\n4. A positive test for hepatitis B surface antigen, hepatitis C antibody or HIV 1 and 2 antibodies.\n5. A history of substance or alcohol abuse within the last year.\n6. Seizure disorders.\n7. Using phosphate binder medication other than calcium based phosphate binders\n8. Using colestyramine, colestipol or colesevelam\n9. A history of drug or other allergy\n10. 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.'}, 'identificationModule': {'nctId': 'NCT00451295', 'briefTitle': 'A Phase III, Multi-Centre, Randomised, Placebo-Controlled Study in Combination With Ca-based P Binders in Patients With Hyperphosphatemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'MCI-196-E09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)']}], 'interventions': [{'name': 'MCI-196(colestilan(INN), Colestimide(JAN), CHOLEBINE®)', 'type': 'DRUG', 'description': '3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frýdek-Místek', 'country': 'Czechia', 'geoPoint': {'lat': 49.68333, 'lon': 18.35}}, {'city': 'Ostrava', 'country': 'Czechia', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Bordeaux', 'country': 'France', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Montpelier', 'country': 'France'}, {'city': 'Aachen', 'country': 'Germany', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Coburg', 'country': 'Germany', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'city': 'Lecco', 'country': 'Italy', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Pavia', 'country': 'Italy', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Skopje', 'country': 'North Macedonia', 'geoPoint': {'lat': 41.99646, 'lon': 21.43141}}, {'city': 'Gdansk', 'country': 'Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Krakow', 'country': 'Poland', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Oświęcim', 'country': 'Poland', 'geoPoint': {'lat': 50.03437, 'lon': 19.21037}}, {'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Wejherowo', 'country': 'Poland', 'geoPoint': {'lat': 54.60568, 'lon': 18.23559}}, {'city': 'Wroclaw', 'country': 'Poland', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Belgrade', 'country': 'Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Niš', 'country': 'Serbia', 'geoPoint': {'lat': 43.32472, 'lon': 21.90333}}, {'city': 'Novisad', 'country': 'Serbia'}, {'city': 'Cape Town', 'country': 'South Africa', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Gauteng', 'country': 'South Africa'}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Oviedo', 'country': 'Spain', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'city': 'Stevenage', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.90224, 'lon': -0.20256}}], 'overallOfficials': [{'name': 'Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Information at Mitsubishi Pharma Europe'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}