Effect of Apiban Therapy on AVF Maturation in ESRD Patients

NCT07559942 | Recruiting

• 1 other identifier: 793/2026
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

End-stage renal disease (ESRD) is a growing global health burden, and the creation of a native arteriovenous fistula (AVF) is the gold standard for vascular access in patients requiring hemodialysis \[1\]. AVFs offer superior longevity, fewer infectious complications, and lower mortality rates compared to central venous catheters or synthetic grafts \[2\]. However, a significant limitation to their widespread success is the high rate of early failure, primarily due to failure to mature (FTM). FTM occurs in 20-40% of AVFs, rendering them unusable for dialysis \[3\]. Apixaban, a direct factor Xa inhibitor, offers a potential advantage by providing sustained anticoagulation throughout the critical maturation period \[7\]. Its predictable pharmacokinetics, oral administration, and favorable safety profile make it an attractive agent for short-term use in this setting \[8\]. By reducing microthrombotic events during the first 4-6 weeks following AVF creation, apixaban could potentially improve maturation rates. However, this potential benefit must be weighed against the increased risk of bleeding, hematoma formation, and wound complications that could negatively impact fistula maturation \[9\].

Conditions

Endstage Renal Disease; Direct Oral Anticoagulants (DOACs); Arterio-venous Fistula, Maturation, Chronic Kidney Disease

Keywords

arteriovenous fistula, maturation, anticoagulation

Outcome Measures

Primary Outcomes (1)

• AV Fistula Maturation

  As per standard definitions

  Six weeks from index operation

Study Arms (2)

Apiban group

EXPERIMENTAL

Apiban 2.5mg BD

Drug: Apixaban

Non-Apiban group

NO INTERVENTION

No Apiban given

Interventions

Apixaban DRUG

Apixaban 2.5mg BD given postoperatively for 6 weeks to intervention arm

Also known as: anticoagulant, DOACs, Apiban

Apiban group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years. Diagnosis of ESRD (eGFR \< 15 mL/min/1.73m² or already on dialysis) with plans for hemodialysis.
• Planned primary upper extremity AVF creation (radiocephalic, brachiocephalic, or brachiobasilic).
• Suitable vessels on preoperative duplex ultrasound (artery ≥ 2 mm, vein ≥ 2.5 mm without tourniquet).
• Ability to provide informed consent.

You may not qualify if:

• Known bleeding diathesis or hypercoagulable state. Current therapeutic anticoagulation (any indication). Current dual antiplatelet therapy. History of intracranial hemorrhage. Known allergy or hypersensitivity to apixaban. Inability to comply with study protocol or follow-up.

Sponsors & Collaborators

• Combined military hospital lahore: lead

Study Sites (1)

Combined Military Hospital, Lahore

Lahore, Punjab Province, 54300, Pakistan

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula; Renal Insufficiency, Chronic

Interventions

apixaban; Anticoagulants

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Muhammad Irfan Khan, Classified Vascular Surgeon

  Combined military hospital lahore

  STUDY CHAIR

Central Study Contacts

Muhammad Kashif, FCPS Surgery, MRCSEd Surgery

CONTACT

00923219698888; kashiramzan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Made available from 1st july 2027 for 1 year

Locations

PA (1)