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Safety and Efficacy Exploratory Study of the Use of Fasudil hydrochloride for Vasospasm on arteriovenous fistula construction

Safety and Efficacy Exploratory Study of the Use of Fasudil hydrochloride for Vasospasm on arteriovenous fistula construction - SAEF-AVF study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031220704
Enrollment
10
Registered
2023-03-14
Start date
2023-05-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage renal failure End-stage renal failure

Interventions

During AVF creation (Immediately prior to beginning dissection of the radial artery), 30 mg of fasudil hydrochloride is diluted in 50 mL of sugar solution and infused intravenously once over approxima

Sponsors

Nakamura Motonobu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Incidence of hypotension and bleeding complications (from study drug administration to 2 weeks postoperatively)

Secondary

MeasureTime frame
1. Initial patency rate (0, 7, and 14 days) 2. Maturity rates (30, 60, and 90 days) and primary patency rates 3. Brachial artery blood flow 4. Blood clots in access circuits

Contacts

Public ContactMotonobu Nakamura

The University of Tokyo Hospital

motonobunakamura@g.ecc.u-tokyo.ac.jp+81-3-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026