The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy
Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
The study will investigate if treatment with Roxadustat improves kidney oxygenation in
diabetic patients with nephropathy receiving treatment for renal anemia, compared to patients
receiving treatment with darbepoetin alpha.
Participants will be randomized to either treatment, and receive equal care for renal anemia.
Kidney oxygenation will be examined before treatment start and after 24 weeks using BOLD-MRI
(blood oxygen level-defendant MRI), a non-invasive method available for measurement of tissue
oxygenation levels that is comparable with direct invasive measurement of partial oxygen
pressure. Blood and urin samples will be collected in connection to these visits. The primary
endpoint is the change in medullary and cortical R2* (inversely proportional to the tissue
oxygenation content) after 24 weeks. Secondary endpoints will be albuminuria and urinary
levels of ROS (evaluated by electron paramagnetic resonance (EPR) spectroscopy with CPH spin
probes).