Study identification

PURI

https://redirect.ema.europa.eu/resource/23377

EU PAS number

EUPAS23376

Study ID

23377

Official title and acronym

A multi-centre, retrospective real world study on the use of renin-angiotensin-aldosterone system inhibitors (RAASi) management in patients treated for chronic kidney disease alongside heart failure and/or type 2 diabetes mellitus. (SoMoR – UK (Study of Management of RAASi in UK))

DARWIN EU® study

No

Study countries

United Kingdom

Study description

To investigate the use of renin-angiotensin-aldosterone system inhibitors (RAASi) in the real world UK NHS setting in patients with chronic kidney disease (CKD) stage 3 or 4 and at least one of the following: heart failure (HF), type 2 diabetes mellitus (T2DM)Where: CKD stage 3+ is defined as estimated glomerular filtration rate (eGFR) 30mls/min <eGFR<60mls/min HF is defined as presence of reduced ejection fraction and left ventricular ejection fraction (LVEF) <40% T2DM is defined as a confirmed diagnosis in medical records

Study status

Planned
Research institution and networks

Institutions

Vifor Pharma
First published:
01/02/2024
Institution
St George's Hospital London, The Royal London London, Leicester General Hospital Leicester, England, Morriston Hospital Swansea, Wales, Dorset County Hospital Dorchester, England

Networks

Contact details

Lisa Moore-Ramdin

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Vifor Pharma UK Ltd
Study protocol
Initial protocol

PT_SoMoR protocol_V4 1_21MAR2018

English (572.04 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable