Forearm Blood Flow in Chronic Kidney Disease patients
Research type
Research Study
Full title
A randomized, repeat dose, open label, parallel group, multi-center study to evaluate the effect of daprodustat compared to darbepoetin alfa on forearm blood flow in participants with anemia of chronic kidney disease that are not dialysis dependent
IRAS ID
228201
Contact name
Joseph Cheriyan
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2017-002268-42
Clinicaltrials.gov Identifier
37177, NIHR CPMS
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Anaemia is a condition in which the number of red blood cells is lower than normal. People with long-term kidney problems are at risk of developing anaemia. Several studies have demonstrated that existing treatments for patients with anaemia of chronic kidney disease (CKD) may cause increased risk of death and cardiovascular symptoms. One possible cause for this may be due to effects on cells which line the blood vessels in the body. Daprodustat is a new drug being developed by GlaxoSmithKline with the potential to treat anaemia of CKD with a lower cardiovascular risk than currently available treatments. Daprodustat has already been tested in healthy people and patients. The purpose of this study is to compare the effect of daprodustat to existing treatments on blood vessels by assessing forearm blood flow (FBF) in approximately 50 patients with anaemia of CKD. The study uses venous occlusion plethysmography (technique to measure changes in volume)as a means to estimate potential for daprodustat to have a lower risk of cardiovascular events compared to existing treatment. Participants will either receive Daprodustat or their usual treatment during the study. The study will comprise three study periods: a screening period starting up to 30 days prior to day 1, a 42 day (6 week) treatment period consisting of 4 visits, and a follow up visit 14 days later. At the 4 treatment visits participants will have vital signs checked, blood and urine samples taken, checks on their medical status and medications they are taking. In addition, at visits 1 & 4 forearm blood flow will be measured using plesmography. This involves inflating and deflating a cuff on the participants wrist and elbow at regular intervals for approximately 2 hours whilst 3 medicines which have different effects on the blood vessels are infused into an artery in the arm.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0154
Date of REC Opinion
29 Mar 2018
REC opinion
Favourable Opinion