Clinical Trial Details
| Trial ID: | L1094 |
| Source ID: | NCT01814904 |
| Associated Drug: | Colestilan-L |
| Title: | Dose-finding Study of MCI-196 |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|Dialysis|Hyperphosphatemia|Paediatric |
| Interventions: | DRUG: colestilan-L|DRUG: colestilan-M|DRUG: colestilan-H|DRUG: CBPB |
| Outcome Measures: | Primary: Mean absolute change in serum phosphorus, 17 weeks | Secondary: 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), 17 weeks|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), 17 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)]), 17 weeks |
| Sponsor/Collaborators: | Sponsor: Mitsubishi Tanabe Pharma Corporation |
| Gender: | ALL |
| Age: | CHILD, ADULT |
| Phases: | PHASE3 |
| Enrollment: | 10 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2014-04 |
| Completion Date: | 2015-01 |
| Results First Posted: | |
| Last Update Posted: | 2015-05-27 |
| Locations: | Investigational site, London, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT01814904 |
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