WHO ICTRP trial
A study to learn more about how safe the study treatment finerenone is in…
EUCTR2021-002905-89-BE · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-002905-89-BE |
|---|---|
| Public title | A study to learn more about how safe the study treatment finerenone is in long-term use when taken with an ACE inhibitor or angiotensin receptor blocker over 18 months of use in children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria |
| Scientific title | An 18-month, open-label, single-arm safety extension study of an age-and bodyweight-adjusted oral finerenone regimen, in addition to an ACEI or ARB, for the treatment of children and young adults from 1 to 18 years of age with chronic kidney disease and proteinuria - FIONA OLE |
| Primary sponsor | Bayer AG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| 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;Czechia;Portugal;Greece;Austria;Netherlands;Sweden;Korea, Republic of;Poland;France;Lithuania;Argentina;Hungary;United Kingdom;Switzerland;Spain;Canada;Czech… |
| Conditions | Treatment of children with chronic kidney disease and proteinuria MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.1… |
| Interventions | Product Name: Finerenone Product Code: BAY 94-8862 10 mg Pharmaceutical Form: Coated tablet INN or Proposed INN: Finerenone CAS Number: 1050477-31-0 Current Sponsor code: BAY 94-8862 Concentration unit: mg milligram(s) Concentration type… |
| Registration date | May 8, 2022 |
| Target size | 100 |
| Secondary IDs | 20186;2021-002905-89-IT |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: