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The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy

ConditionsDiabetes ComplicationsDiabetes; Nephropathy (Manifestation)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Roxadustat

    Drug

    The group will receive Roxadustat (Evrenzo) three times weekly at an initial dose of 70mg (for body weight \<100.0 kg) or 100 mg (for body weight weight ≥100.0 kg). The dosage for both arms will be adjusted to keep Hb at the recommended levels between 11-12g/dl. The aim is to investigate the effects of systemic administration of Evrenzo (Roxadustat \[RD\]) or Aranesp (darbepoetin alpha \[DA\]) on the levels of renal oxygenation in patients with diabetic nephropathy and associated anemia.

  • Darbepoietin Alfa

    Drug

    The control group will receive darbepoietin alpha (Aranesp) s.c. 0.45mg/kg once a week. The dosage for both arms will be adjusted to keep Hb at the recommended levels between 11-12g/dl. The aim is to investigate the effects of systemic administration of Evrenzo (Roxadustat \[RD\]) or Aranesp (darbepoetin alpha \[DA\]) on the levels of renal oxygenation in patients with diabetic nephropathy and associated anemia.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: RoxadustatActive comparator 1 intervention
Group B: Darbepoietin alphaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in kidney oxygenation levels

Kidney oxygenation will be evaluated using BOLD-MRI prior to start of therapy, and once again after 24 weeks of treatment with either RD or DA. Primary endpoint is the change in medullary and cortical R2\* (inversely proportional to the tissue oxygenation content) after 24 weeks.

Time frame
24 Weeks

Secondary outcomes

1

Change in albuminuria

Secondary endpoint will be albuminuria after 24 weeks of either treatment

Time frame
24 Weeks
2

Change in urinary reactive oxygen species (ROS)

Secondary endpoints will be urinary levels of ROS (evaluated by electron paramagnetic resonance (EPR) spectroscopy with CPH spin probes).

Time frame
24 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Stockholm

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: