Phase I trial: Royal Infirmary Edinburgh Clinical Research Facility code: 003

ISRCTN	ISRCTN76722400
DOI	https://doi.org/10.1186/ISRCTN76722400
EudraCT/CTIS number	2021-001969‐20
IRAS number	1004538
Secondary identifying numbers	IRAS 1004538, CPMS 51275

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

Royal Infirmary Edinburgh Clinical Research Facility
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Phone	0131 242 7183
Email	info@edinburghcrf.ed.ac.uk

Study information

Study design	First-in-human single-ascending-dose multiple-ascending-dose study
Primary study design	Interventional
Secondary study design	Randomized trial
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format
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
Pharmaceutical study type(s)
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	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.
Secondary outcome measures	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.
Overall study start date	27/01/2022
Completion date	15/04/2023

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	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 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

Sponsor information

Vifor (International) Inc.
Industry

Rechenstrasse 37
St. Gallen
9014
Switzerland

Phone	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. Deferral was approved on 25 May 2022. The full details will be added to the study record within 30 months after the trial has ended.
Email	transparency@viforpharma.com
Website	http://www.viforpharma.com/en/

Funders

Funder type

Industry

Vifor (International) Inc.

No information available

Results and Publications

Intention to publish date	15/10/2025
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this phase I study and the negligible benefit to the public of phase I information. Results will be posted on or after the date of publication of full trial details.
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

Editorial Notes

01/11/2022: Internal review.
20/10/2022: Trial's existence confirmed by the HRA.