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Clinical Trials/JPRN-jRCTs031220704
JPRN-jRCTs031220704
Recruiting
Phase 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 enrollmentMarch 14, 2023
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
akamura Motonobu
Enrollment
10
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 14, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
akamura Motonobu

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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