Health Condition 1: N184- Chronic kidney disease, stage 4 (severe) Health Condition 2: N185- Chronic kidney disease, stage 5
Conditions
Interventions
Intervention1: AntiPlatelet, AntiCoagulant (APAC): Single (1 ml rinse pre surgery + 2ml post surgery) intraluminal dose only during the surgery at each of the 3 dose levels
Control Intervention1: Sali
Sponsors
Cadila Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Dialysis naïve patients with CKD stages 4 and 5 (defined as an eGFR less than 30 mL/min/1.73m2), �18 and hemodialysis access surgery. 2.Patient eligible to undergo AVF surgery as determined by the nephrologist and surgeon. 3.Patients with appropriate vessel diameters: a radial artery and a cephalic vein diameter � 2 mm (inner-to-inner diameter), measured via duplex ultrasound. 4.Venous patency in the draining vein with no stenosis or thrombosis, with visible, palpable, and compressible (thrombus free) vein. 5.Life expectancy of at least 12 months and not likely to require kidney transplantation within 3 months of administration of study medication. 6.Patients able to provide written informed consent and willing to follow all study requirements.
Exclusion criteria
Exclusion criteria: 1.Patients already receiving hemodialysis or who have previously undergone dialysis, successful or otherwise. 2.Existing AVF at any anatomical site. 3.Patients in whom the intended site for surgical intervention is the only potential site for an AVF. 4.Patients taking a contraindicated medication which will interfere with the study outcome. 5.Patients receiving warfarin, unfractionated heparin, LMWH or any other systemic anticoagulant, such as direct oral anticoagulants at Screening 6.Patients who are taking or who have taken antiplatelet agents during 30 days prior to Screening, excluding aspirin. 7.Patients with a history of known sensitivity to heparin or aspirin. 8.Patients with APTT i.e., â?¥1.5-fold prolongation, PT >1.5 of ULN, LFT >2.5 of ULN, Hb 9.Patients with a history of myocardial infarction, stroke, peripheral arterial occlusive disease, angioplasty, previous venous thromboembolism, transient ischemic attack (TIA). 10.Patients with known medical history of nephrotic syndrome, arterial aneurysm, heparin-induced thrombocytopenia, inherited or acquired thrombophilic condition or symptoms of fever or active infection or any other medical condition or underlying cause for their CKD. 11.Patients demonstrating an absence of radial and/or ulnar arterial blood flow or non-patent palmer arch, as determined via a modified Allen test at Screening. 12.Patients with any systemic condition (as noted in their medical history at Screening) known to be associated with impaired hemostasis e.g., hemophilia, Von Willebrandâ??s disease or other bleeding disorders. 13.Concurrent involvement in any other clinical study with an investigational drug or device, or participation in a clinical study within 30 days prior to entering the study. 14.Female patients who are pregnant, lactating or of childbearing potential and unwilling or unable to use adequate contraception 15.Patients who for any reason, in the investigatorâ??s opinion, are unsuitable for enrolment into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the highest safe dose by evaluating the safety and tolerability of of APAC during AVF creation in patients with CKDTimepoint: During the first 24-hours post-the AVF surgery and administration of APAC | — |
Secondary
| Measure | Time frame |
|---|---|
| To establish the safety and tolerability profile of APACTimepoint: During the 4 weeks post-surgery and treatment;Determination of AVF maturation rate, functional AVF patency rate and AVF failure rateTimepoint: At Week 4 following surgery;To determine a Recommended Phase 2 Dose(s) (RP2D)Timepoint: During 4 weeks post-surgery and treatment | — |
Countries
India
Contacts
Public ContactDr Sanjay Patel
Cadila Pharmaceuticals Limited
Outcome results
None listed