WHO ICTRP trial
Study to investigate the safety and efficacy of tacrolimus in kidney transplant…
EUCTR2015-003288-12-Outside-EU/EEA · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2015-003288-12-Outside-EU/EEA |
|---|---|
| Public title | Study to investigate the safety and efficacy of tacrolimus in kidney transplant recipients |
| Scientific title | A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (tacrolimus)/MMF, Modified Release (MR) Tacrolimus /MMF and Neoral®(cyclosporine)/MMF in de novo Kidney Transplant |
| Primary sponsor | Fujisawa Healthcare, Inc. |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Countries | United States;Brazil;Canada |
| Conditions | Kidney transplant recipients MedDRA version: 18.0 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 100000004865 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] |
| Interventions | Trade Name: Prograf Pharmaceutical Form: Capsule, hard INN or Proposed INN: TACROLIMUS CAS Number: 104987-11-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Trade Name: Prograf Pharmaceutical Form… |
| Registration date | May 8, 2015 |
| Target size | 660 |
| Secondary IDs | 02-0-158 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: