Clinical Trial Details
| Trial ID: | L1072 |
| Source ID: | NCT01814917 |
| Associated Drug: | Colestilan |
| Title: | Long-term Extension Study of MCI-196 |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|Dialysis|Hyperphosphatemia|Paediatric |
| Interventions: | DRUG: colestilan|DRUG: CBPB |
| Outcome Measures: | Primary: Proportion of responders (responders are defined as subjects demonstrating serum P levels ≤1.5 SD above the KDOQI 2008 age-related mean value), Kidney Disease Outcomes Quality Initiative (KDOQI), 52 weeks | Secondary: Mean absolute change in efficacy laboratory parameters (i.e.,P, Ca, Ca P ion product [CaxP], intact parathyroid hormone [iPTH], serum glucose, glycosylated haemoglobin [HbA1c], and uric acid), 52 weeks|Mean percentage change in other efficacy laboratory parameters (i.e., lipid parameters [low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), total cholesterol, and triglycerides (TG)]), 52 weeks |
| Sponsor/Collaborators: | Sponsor: Mitsubishi Tanabe Pharma Corporation |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE3 |
| Enrollment: | 6 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2013-08 |
| Completion Date: | 2014-12 |
| Results First Posted: | |
| Last Update Posted: | 2015-05-27 |
| Locations: | Investigational site, London, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT01814917 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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