WHO ICTRP trial
A study to evaluate the effectiveness and safety of a study drug called…
EUCTR2021-003994-72-FR · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2021-003994-72-FR |
|---|---|
| Public title | A study to evaluate the effectiveness and safety of a study drug called vadadustat in the maintenance treatment of anemia for children, naïve to ESA therapy |
| Scientific title | A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ONCE DAILY ORAL VADADUSTAT FOR THE TREATMENT OF PEDIATRIC SUBJECTS WITH ANEMIA OF CHRONIC KIDNEY DISEASE NAÏVE TO ERYTHROPOIESIS-STIMULATING AGENTS |
| Primary sponsor | Akebia Therapeutics, Inc. |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;France;Hungary;Spain;Poland;Netherlands;Germany;Italy |
| Conditions | Anemia of Chronic kidney disease (CKD) MedDRA version: 20.0 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 100000004851 MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease… |
| Interventions | Product Name: Vadadustat Product Code: AKB-6548 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VADADUSTAT CAS Number: 1000025-07-9 Current Sponsor code: AKB-6548 Concentration unit: mg/g milligram(s)/gram Concentration type… |
| Registration date | Jan 31, 2022 |
| Target size | 71 |
| Secondary IDs | AKB-6548-CI-0042;CORRECTION;2021-003994-72-HU |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: