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The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy

NCT05810311 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-19

No results posted yet for this study

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).

Conditions

  • Diabetes Complications
  • Diabetes; Nephropathy (Manifestation)

Interventions

DRUG

Roxadustat

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.

DRUG

Darbepoietin Alfa

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.

Sponsors & Collaborators

  • Region Stockholm

    lead OTHER_GOV

Principal Investigators

  • Sergiu Catrina, Ass. Proff. · Karolinska institute, Centre for diabetes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-01-01
Completion
2027-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05810311 on ClinicalTrials.gov