| CTRI Number |
CTRI/2021/12/038373 [Registered on: 02/12/2021] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Phase I clinical study of AntiPlatelet, AntiCoagulant (APAC) in chronic kidney disease patients to facilitate hemodialysis access. |
|
Scientific Title of Study
|
A Phase I clinical study of locally administered AntiPlatelet, AntiCoagulant (APAC) at the time of
vascular surgery to create a radiocephalic arterio-venous fistula (RCAVF) in patients with
chronic kidney disease (CKD) to facilitate hemodialysis access. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRSC19001 Version 02, dated 01/04/2021 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Arani Chatterjee |
| Designation |
Head - Cadila CRO |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
1389, Trasad Road, Clinical Research Division,
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India |
| Phone |
912714221481 |
| Fax |
|
| Email |
arani.chatterjee@cadilapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Mr. Ashish Amarsheda |
| Designation |
Senior Manager |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
1389, Trasad Road
Dholka, Ahmedabad
1389, Trasad Road
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India |
| Phone |
912714221481 |
| Fax |
|
| Email |
ashish.a@cadilapharma.cm |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sanjay Patel |
| Designation |
General Manager |
| Affiliation |
Cadila Pharmaceuticals Limited |
| Address |
1389, Trasad Road
Dholka, Ahmedabad
1389, Trasad Road
Dholka, Ahmedabad
Ahmadabad
GUJARAT
382225
India |
| Phone |
912714221481 |
| Fax |
|
| Email |
sanjay.p@cadilapharma.com |
|
|
Source of Monetary or Material Support
|
| Cadila Pharmaceuticals Limited. 1389, Trasad Road. Dholka – 382225. Ahmedabad. Gujarat. India. |
|
|
Primary Sponsor
|
| Name |
Cadila Pharmaceuticals Limited |
| Address |
1389, Trasad Road. Dholka – 382225. Ahmedabad. Gujarat. India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinay Rathore |
All India Institute of Medical Science, Raipur |
Department of Nephrology, Gate no.04, G.E. Road, Tatibandh. 492099.
Raipur
CHHATTISGARH |
9914699651
drvinayrathoredm@aiimsraipur.edu.in |
| Dr Haresh Patel |
Apollo Hospital International Ltd. |
Department of Nephrology, Plot No. -1A, Bhat, GIDC Estate, Gandhinagar 382428, Gujarat.
India.
Ahmadabad
GUJARAT |
9824612092
patelharesh74@rediffmail.com |
| Dr Umesh Ramjibhai Godhani |
Devasya Kidney & Multi speciality Hospital |
Nr. Bhimajipura Cross Roads, New Vadaj Road, Ahmedabad-380 013.
Ahmadabad
GUJARAT |
9825306544
drumesh.godhani@gmail.com |
| Dr Balasubramaniyan Thoppalan |
Government Kilpauk Medical College and Hospital |
EVR Periyar Salai Kilpauk, Chennai, Tamilnadu, India-600010
Chennai
TAMIL NADU |
9840062496
drbalasubramaniyan.gkmc@gmail.com |
| Dr Kalpesh Gohel |
Kiran Multi Super Speciality Hospital & Research Center |
Near Sumul Dairy Road, Katargam, Surat, Gujarat 395004.
Surat
GUJARAT |
9824447362
drkalpeshdgohel@gmail.com |
| Dr Abhishek Singh |
Muljibhai Patel Urology Hospital |
Dr. Virendra Desai road, Nadiad - 387001
Kheda
GUJARAT |
9970378000
drabhisheksingh82@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Raipur |
Approved |
| Institutional Ethics Committee, Apollo Hospital, Ahmedabad |
Approved |
| Institutional Ethics Committee, Government Kilpauk Medical college |
Approved |
| Kiran Hospital Ethics Committee |
Approved |
| Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee |
Approved |
| Shrey Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (2) ICD-10 Condition: N185||Chronic kidney disease, stage 5, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
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 |
| Comparator Agent |
Saline as control treatment |
Single (1 ml rinse pre surgery + 2ml post surgery) intraluminal dose of Saline only during the surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Dialysis naïve patients with CKD stages 4 and 5 (defined as an eGFR less than 30 mL/min/1.73m2), ≥18 and <65 years of age of either gender, requiring
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. |
|
| ExclusionCriteria |
| Details |
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., ≥1.5-fold prolongation, PT >1.5 of ULN, LFT >2.5 of ULN, Hb <7 g/dL
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 Willebrand’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 investigator’s opinion, are unsuitable for enrolment into the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determination of the highest safe dose by evaluating the safety and tolerability of of APAC during AVF creation in patients with CKD |
During the first 24-hours post-the AVF surgery and administration of APAC |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish the safety and tolerability profile of APAC |
During the 4 weeks post-surgery and treatment |
| Determination of AVF maturation rate, functional AVF patency rate and AVF failure rate |
At Week 4 following surgery |
| To determine a Recommended Phase 2 Dose(s) (RP2D) |
During 4 weeks post-surgery and treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
16/05/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Phase I, prospective, open label, dose finding, First in Human clinical study to assess the safety and tolerability of either single (1 ml rinse pre surgery + 2 ml post surgery) dose APAC or control treatment at the time of RCAVF creation in 30 CKD patients (10 in each cohort) undergoing AVF creation to facilitate hemodialysis. Total 3 dose levels of APAC will be evaluated and patients participation duration will be of 4 week. |