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The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy

Study acronym: FOXTROT
StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date: Jan 1, 2025 to Jan 1, 2027
    • Start date: Jan 1, 2024 to Jun 1, 2025
    • Study completion date: Dec 31, 2025 to Dec 31, 2027
    v3
  2. Study description shortened, about 4 wordsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Region Stockholm
88 trials monitored
See 2 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
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).
Trial Details
NCT Number NCT05810311
Lead Sponsor Region Stockholm
Conditions
(from sponsor)		 Diabetes Complications, Diabetes; Nephropathy (Manifestation)
Related terms Diabetes Complications, Diabetes Mellitus, Hypoxia, Kidney Diseases
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov