The Effect of Roxadustat on the Levels of Renal Oxygenation in Patients With Diabetes Nephropathy (FOXTROT)

FOXTROT

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).

2024-01-01

2025-01-01

2025-12-31

Not yet recruiting

Early phase I

30

Inclusion Criteria: 1. Diabetes mellitus with anemia caused by DKD, and indication for treatment with erythropoetin/erythropoietin-stimulating drugs. 2. Age 18-75 3. HbA1c \>55 4. Diabetes duration 10+ years. 5. Chronic kidney disease (CKD) stage 3-4 6. Symptomatic anemia with Hb \<10g/dl 7. Contraception: Female subjects must be postmenopausal, surgically sterile, or if premenopausal (and not surgically sterile), be prepared to use ≥1 effective method of contraception during the study and for 30 days after the last visit. Effective methods of contraception are those listed below: 1. Double barrier method, i.e. (a) condom (male or female) or (b) diaphragm, with spermicide; or 2. Intrauterine device; or 3. Vasectomy (partner); or 4. Hormonal (e.g., contraceptive pill, patch, intramuscular implant, or injection); or 5. Abstinence, if in line with the preferred and usual lifestyle of the subject. 8. Signed informed consent. Exclusion Criteria: 1. Anemia not related to CKD. 2. Dialysis dependent CKD 3. Currently treated for renal anemia using erythropoietin-stimulating drugs 4. Infections during the last 30 days. 5. Severe hypertension (≥180mmHg systolic or \>110mmHg diastolic blood pressure) 6. Liver failure (Child-Pugh class B-C) 7. History of epilepsy or seizures 8. Any concomitant disease or condition that may interfere with the possibility for the patient to comply with or complete the study protocol. 9. Ongoing drug or alcohol abuse. 10. Known allergy to RD or DA 11. Malignancy 12. Severe claustrophobia 13. Participation in another ongoing pharmacological study 14. If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or currently breastfeeding. 15. Unwillingness to participate following oral and written information 16. Other severe acute or chronic medical or psychiatric condition that makes the subject inappropriate for the study, as judged by the investigator. 17. History of thrombosis (DVT, pulmonary embolism)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The research design is a randomized prospective, open-label study with parallel groups of 15 patients/group with non-dialysis dependent DKD CKD stage 3-4 with Hb \\<10g/dl.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-05-10