The Effect of Roxadustat on Renal Oxygenation in Diabetes Nephropathy

Launched by REGION STOCKHOLM · Apr 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Roxadustat to see if it can improve oxygen levels in the kidneys of patients who have diabetes and kidney problems, specifically diabetic nephropathy. The trial will compare Roxadustat to another treatment called darbepoetin alpha, which is also used for kidney-related anemia. Patients who participate will receive one of these treatments and will have their kidney oxygen levels checked before starting the treatment and again after 24 weeks using a special MRI technique that measures oxygen levels in the body without needing any surgery.

To be eligible for this trial, participants must be between 18 and 75 years old, have diabetes with related anemia, and meet certain health criteria, such as having chronic kidney disease that is not yet requiring dialysis. Women who are able to become pregnant must agree to use effective birth control during the study. Participants can expect to have blood and urine samples taken at the beginning and end of the study, and they will receive careful monitoring and support throughout the process. This trial is not yet recruiting, but it represents a hopeful step towards finding better treatments for those affected by diabetes-related kidney issues.

Gender

ALL

Eligibility criteria

• 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)