JPRN-jRCTs031220704RecruitingPhase 2
Safety and Efficacy Exploratory Study of the Use of Fasudil hydrochloride for Vasospasm on arteriovenous fistula construction - SAEF-AVF study
akamura Motonobu0 sites10 target enrollmentStarted: March 14, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to < 90age old (—)
- Sex
- All
Inclusion Criteria
- •1. Patients with end-stage renal failure
- •2. Those planning to construct an AVF using the radial artery-radial cutaneous vein
- •3. Age: Persons who are over 18 and under 90 years of age at the time of obtaining consent
- •4. Gender: any gender
- •5. Those who have given written consent of their own free will after receiving a sufficient explanation for participating in this research.
- •6. Those who can make outpatient visits in accordance with the research implementation schedule
Exclusion Criteria
- •1. Those with low blood pressure (systolic blood pressure: 100 mmHg or less)
- •2. Those with possible intracranial hemorrhage
- •3. Those with hepatic dysfunction
- •4. Those who received fasudil hydrochloride within 12 weeks prior to obtaining consent
- •5. Those complicated with malignant tumors
- •6. Those with a history of serious drug allergy such as anaphylactic shock or a history of serious adverse drug reactions
- •7. Those who have participated in a clinical trial or clinical study and taken study medication within 4 weeks prior to obtaining consent
- •8. Those who have attempted to construct an AVF in the past
- •9. Those who are pregnant or possibly pregnant
- •10. Those who are breastfeeding
- •11. Those deemed by the principal investigator or sub investigator to be inappropriate to participate in this study
Investigators
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