The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRegion Stockholm

About this trial

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).

Eligibility criteria

Qualifiers

Diabetes mellitus with anemia caused by DKD, and indication for treatment with erythropoetin/erythropoietin-stimulating drugs.

Age 18-75

HbA1c >55

Diabetes duration 10+ years.

Disqualifiers

Anemia not related to CKD.

Dialysis dependent CKD

Currently treated for renal anemia using erythropoietin-stimulating drugs

Infections during the last 30 days.

Trial design

Treatments tested in this trial

  • Roxadustat
  • Darbepoietin Alfa

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators