| CTRI Number |
CTRI/2019/03/018081 [Registered on: 13/03/2019] Trial Registered Prospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Phase 2 study of indigenous dialysis machine |
|
Scientific Title of Study
|
Pivotal phase-2 trials of the first Indian hemodialysis device with a telenephrology based rural care delivery model |
| Trial Acronym |
Renalyx RxT17 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjunath S Shetty |
| Designation |
Professor and Head of department of Nephrology |
| Affiliation |
JSS Hospital |
| Address |
Department of Nephrology, room number 1023, JSS Hospital, Mahatma Gandhi Road
Ramachandra Agrahara
Mysore
Dialysis unit, room number 17,
JSS Hospital,JSS College Rd
Chamrajnagar
Chamarajanagar
KARNATAKA
570004
India |
| Phone |
9880739069 |
| Fax |
|
| Email |
drmanjunathsshetty@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Sharma |
| Designation |
Chief Research Officer |
| Affiliation |
Renalyx Health Systems Pvt. Ltd |
| Address |
19-19/1, 2nd Floor,
south end Rd, Basavangudi
Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
8884151372 |
| Fax |
|
| Email |
drsharma@renalyx.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran KK |
| Designation |
Assistant Professor, Department of Nephrology |
| Affiliation |
JSS Hospital |
| Address |
Department of Nephrology, room number 1024, JSS hospital, Mahatma Gandhi Road
Ramachandra Agrahara
Mysore
Dialysis unit, room number 17, JSS Hospital,JSS College Rd
Chamrajnagar
Chamarajanagar
KARNATAKA
570004
India |
| Phone |
9845207534 |
| Fax |
|
| Email |
drkirankk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Renalyx Health Systems Pvt Ltd
19-19/1, 2nd floor
South End Rd,
Basavangudi, Bangalore-56004 |
|
|
Primary Sponsor
|
| Name |
Renalyx Health Systems Pvt Ltd |
| Address |
19-19/1, 2nd floor
South End Rd,
Basavangudi, Bangalore-56004 |
| Type of Sponsor |
Other [Medical technology and device] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kiran |
JSS Hospital |
Mahatma Gandhi Road,
Ramachandra Agrahara
Mysore- 57004
Mysore
KARNATAKA |
9845207534
drkirankk@gmail.com |
| Dr Kiran |
JSS Hospital |
Dialysis unit, Room number 17,
JSS College Rd, Chamarajanagar
Chamarajanagar
KARNATAKA |
9845207534
drkirankk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, JSS Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fresenius 4008S(Fresenius
Medical Care AG & Co. KGaA,
Bad Hambourg, Germany) |
The market standard Fresenius 4008S hemodialysis machine that can perform both dialysis and isolated ultrafiltration. This
device has been designed and
developed with the aim to
reduce the coast of
hemodialysis within India and developing countries. The machine is fitted with standard extracorporeal consumables
available in the market. The aim of utlising a baseline HD session is to compare the
outcomes of the intervention
RxT17. |
| Intervention |
Renalyx RxT17 HD |
An indigenous hemodialysis
machine that can perform both dialysis and isolated
ultrafiltration. This device has been designed and developed with the aim to reduce the coast of hemodialysis within India and developing countries. The machine is fitted with standard extracorporeal consumables available in the market. The aim
of the study is to test the safety and efficacy of the Renalyx RxT17 HD in addition to test the remote monitoring faeture of the hemodialysis device. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing and competent to sign the approved informed consent.
Patient must be at least 21 years of age or older.
Patient must weigh between 40 and 100kg, inclusive.
Patient must have End Stage Renal Disease and currently undergoing consistent intermittent HD at least 2 times a week for at least 3 months prior to being enrolled.
Vascular access must be through a functioning arteriovenous fistula (AVF) with no thrombolytic therapy or clotting of the AVF within the past 4 weeks.
Willing to comply with the requirements of experimental treatment with the follow-up after 24 hours.
Expected survival of no less than 6 months.
Consent to allow review of their medical records by the investigators, and monitors.
Hemoglobin level ≥ 8.0 g/dL prior to hemodialysis treatment. |
|
| ExclusionCriteria |
| Details |
Anticipating or scheduled for a living related donor kidney transplant in less than 2 months.
History (within the 12 weeks prior to the study) of cardiovascular events including.
Unstable angina
Myocardial Infarction
Stroke
Clinical Significant Arrhythmia.
Life threatening arrhythmia within the past 30 days.
Severe intra-dialytic hypotension within the last 30 days.
Shock within the last 30 days.
Hemodynamic instability as demonstrated by repeated episodes of hypotension or hypertension requiring intervention by dialysis personnel or representing a present hazard to the patient.
Seizure disorder requiring active treatment for a seizure episode during the last 6 months.
Major Surgery (excluding vascular access surgery) within the past 30 days.
Currently receiving intravenous antibiotic therapy for systemic infection.
Clinical evidence of metastatic malignancy, receiving radiation or chemotherapy, within the past 365 days.
Active bleeding.
Hematological disease (e.g. malignancies, hemolytic anemia, thrombocytopenia), and other conditions that may interfere with data.
Current enrollment in another investigational device or drug trial.
Subject is pregnant (e.g., positive HCG test) or is breast-feeding.
Subject has any disorder (excluding illiteracy or visual impairment) that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures.
Allergy to heparin or ethylene oxide.
Hypertension deemed uncontrolled, at the discretion of the investigator, within the past 30 days.
Has an implantable electronic device (e.g. pacemaker).
Has no positive viral serology.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety and Efficacy of device |
4 hours per session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effectiveness of remote monitoring
Costs (direct and indirect) |
4 hours per session |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/05/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective study, open labelled, controlled crossover interventional study designed to provide the phase-2 trial data of the first Indian hemodialysis device (RxT17). One hundred and thirty sessions of hemodialysis involving stable chronic kidney disease (CKD) stage -V subjects, receiving regular intermittent hemodialysis (HD) treatment via an arteriovenous fistula as vascular access, will be studied. The RxT17 device is intended to potentially respond to the unmet public health needs of the rural Indian CKD-V patients. The patients will also be monitored using a remote care delivery model in addition to the conventional care using the Fresenius 4008S machine for comparision of primary outcomes. It is expected to improve outcomes, reduce costs and provide treatment access to patients with end stage renal disease (ESRD), especially in rural India and developing world. |