WHO ICTRP trial
A clinical study to investigate how MCI-196 lowers phosphate levels in patients…
EUCTR2012-002583-27-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2012-002583-27-DE |
|---|---|
| Public title | A clinical study to investigate how MCI-196 lowers phosphate levels in patients over a long period of time, who have previously participated in the short-term MCI-196 studies and suffer from hyperphosphatemia (high levels of phopshorus in the blood), who have stage 5 chronic kidney disease and are on dialysis or who have stages 3b to 5 chronic kidney disease and are not on dialysis. MCI-196 phosphate-lowering effect will be compated to patients taking calcium-based phosphate binders. |
| Scientific title | A Multi-centre, Flexible Dose, Parallel Group, Open-label, Active Control (Calcium-based Phosphate Binder), Long-term Extension Study Evaluating the Efficacy, Safety and Tolerability of Colestilan (MCI-196) in Paediatric Subjects With Hyperphosphataemia and With Either Chronic Kidney Disease Stage 5… |
| Primary sponsor | Mitsubishi Tanabe Pharma Corporation (MTPC) |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Countries | Turkey;Germany |
| Conditions | Hyperphosphataemia MedDRA version: 17.1 Level: PT Classification code 10020711 Term: Hyperphosphataemia System Organ Class: 10027433 - Metabolism and nutrition disorders ;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] |
| Interventions | Trade Name: BindRen® 1 g Film-coated Tablets Product Code: MCI-196 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: COLESTILAN CAS Number: 95522-45-5 Current Sponsor code: MCI-196 Concentration unit: g gram(s) Concentration… |
| Registration date | Dec 19, 2012 |
| Target size | 100 |
| Secondary IDs | MCI-196-E15 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: