Modulators of the hypoxia-inducible factor (HIF) pathway (roxadustat) and their impact on the pulmonary vasculature in humans

niversity of Oxford0 个研究点目标入组 20 人开始时间: 2023年12月18日最近更新: 2024年1月8日

适应症

试验速览

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•1. Male and female, aged 19–60 years old
•2. Willing and able to provide informed consent for participation in the study
•3. Not currently taking any significant medications (to be reviewed and confirmed on a case-by-case assessment by a clinically qualified researcher)
•4. Not taking the combined oral contraceptive pill. The progesterone-only pill (‘mini pill’) is acceptable.
•5. No pre-existing significant medical conditions – this will be decided after a case-by-case assessment by a clinically qualified researcher

•1. Inability to tolerate face mask/mouthpiece/nose clip (for experimental procedure)
•2. Pregnant or breastfeeding
•3. Significant regular medication that could affect the result of the study (interaction with hypoxia or a possible effect on the pulmonary vasculature) and/or has a known interaction with roxadustat.
•4. Previous or current significant medical problems may be an exclusion – this will be decided after a case-by-case assessment by a clinical-qualified researcher:
•4.1. Pre-existing cardiorespiratory disease
•4.2. Pre-existing renal or hepatic impairment
•4.3. History of or current significant psychiatric illness
•4.4. History of or current significant neurological condition (e.g. epilepsy)
•4.5. History of or current venous thromboembolism, pulmonary embolism, or thrombophilia
•4.6. Current participation in other research studies
•4.7. Recent (within one month) excursions to altitude above 2500 m (with case-by-case assessment for long sojourns); recent (within 1 week) air travel over 4 hours duration
•4.8. Known pre-existing anaemia and/or iron deficiency
•4.9. Hypersensitivity to peanut or soya (roxadustat tablets contain traces of soya lecithin and a hypersensitivity to peanut or soya is listed as a contraindication to prescription)

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