Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
17
Countries
2
Sites
2
IgAN is Primary Immunoglobulin A Nephropathy (IgAN) (also known as Berger's disease)
Key facts
- Sponsor
- Takeda Development Center Americas Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 25 Jul 2022 → 15 Dec 2025
- Decision date (initial)
- 2024-10-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516743-34-00
- EudraCT number
- 2021-005023-20
- ClinicalTrials.gov
- NCT05174221
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
IgAN is Primary Immunoglobulin A Nephropathy (IgAN) (also known as Berger's disease)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10021263 | IgA nephropathy | 100000004857 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Takeda Development Center Americas Inc.
- Sponsor organisation
- Takeda Development Center Americas Inc.
- Address
- 500 Kendall Street
- City
- Cambridge
- Postcode
- 02142-1108
- Country
- United States
Scientific contact point
- Organisation
- Takeda Development Center Americas Inc.
- Contact name
- Mary Katherine Farmer
Public contact point
- Organisation
- Takeda Development Center Americas Inc.
- Contact name
- Takeda
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 1 | 1 |
| Spain | Ended | 2 | 1 |
| Rest of world
Singapore, United Kingdom, China, Korea, Democratic People's Republic of, Japan, United States, Taiwan, Australia
|
— | 14 | — |
Investigational sites
Semmelweis University
Belgyógyászati és Onkológiai Klinika, Klinikai Farmakológiai részleg, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Hungary | 2023-04-12 | 2025-03-25 | 2023-04-20 | 2023-05-25 | |
| Spain | 2022-07-25 | 2025-01-09 | 2022-10-05 | 2023-03-07 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | Spain | Acceptable 2024-10-14
|
2024-10-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-20 | Acceptable 2025-05-12
|
2025-05-21 |