Phase I trial: Royal Infirmary Edinburgh Clinical Research Facility code: 003
| ISRCTN | ISRCTN76722400 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76722400 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2021-001969‐20 |
| Integrated Research Application System (IRAS) | 1004538 |
| Protocol serial number | IRAS 1004538, CPMS 51275 |
| Sponsor | Vifor (International) Inc. |
| Funder | Vifor (International) Inc. |
- Submission date
- 13/10/2022
- Registration date
- 20/10/2022
- Last edited
- 01/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Contact information
Dr David Newby
Principal investigator
Principal investigator
Royal Infirmary Edinburgh Clinical Research Facility
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
| Phone | 0131 242 7183 |
|---|---|
| info@edinburghcrf.ed.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | First-in-human single-ascending-dose multiple-ascending-dose study |
| Secondary study design | Randomized trial |
| Study type | Participant information sheet |
| Scientific title | Phase I trial: Royal Infirmary Edinburgh Clinical Research Facility code: 003 [The full scientific title will be published within 30 months after the end of the trial] |
| Study objectives | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Ethics approval(s) | 1. Approved 31/01/2022, North East - York Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 1048091; york.rec@hra.nhs.uk), ref: 22/NE/0004 2. Approved 09/02/2022, Medicines & Healthcare products Regulatory Agency (MHRA) (10 South Colonnade, Canary Wharf, London, E14 4PU, UK, +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 55892/0001/001 The HRA has approved deferral of publication of trial details. |
| Health condition(s) or problem(s) studied | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Intervention | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Primary outcome measure(s) |
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key secondary outcome measure(s) |
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Completion date | 15/04/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 90 |
| Key inclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key exclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Date of first enrolment | 29/10/2021 |
| Date of final enrolment | 15/04/2023 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
-
-
United Kingdom
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
01/11/2022: Internal review.
20/10/2022: Trial's existence confirmed by the HRA.
