| CTRI Number |
CTRI/2018/02/011882 [Registered on: 13/02/2018] Trial Registered Prospectively |
| Last Modified On: |
13/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the safety and effectiveness of the first Indian dialysis machine. |
|
Scientific Title of Study
|
Clinical Safety and Efficacy Testing Of The First Indian Hemodialysis Device. |
| Trial Acronym |
|
|
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 |
JSS Hospital,
Department of Nephrology, Room no 1024
Mahathma Gandhi Road, Mysore
Karnataka, India.
Mysore
KARNATAKA
57004
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 |
No 3, 5th C main Rd, Tata Silk Farm, K.R. Road, Banashankari II Stage
Bangalore
KARNATAKA
560070
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 |
JSS Hospital
Department of Nephrology,
Room no 1027
Mahathma Gandhi Road, Mysore
Karnataka, India
Mysore
KARNATAKA
57004
India |
| Phone |
9845207534 |
| Fax |
|
| Email |
drkirankk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Renalyx Health Systems Pvt.Ltd
3, 5th C main, K R road, Tata Silk Farm, Bangalore 560070 |
|
|
Primary Sponsor
|
| Name |
Renalyx Health Systems Pvt Ltd |
| Address |
3, 5th C main Rd, Tata Silk Farm, K.R. Road, Banashankari II Stage, Bengaluru 560070 |
| Type of Sponsor |
Other [Medical technology and device] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manjunath S Shetty |
JSS Hospital |
JSS Hospital,
Department of Nephrology,
Dialysis Unit, Ground floor
Mahathma Gandhi Road, Mysore
Mysore
KARNATAKA |
9880739069
drmanjunathsshetty@yahoo.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 |
These patients have CKD stage V on normal intermittent haemodialysis. The subjects are atleast 21 years old with no history of cancer or recent surgeries and expected survival of atleast 6 months., |
|
|
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 bench mark the outcomes of the intervention (RxT17).This dialysis sessions will be a total of 5 sessions on 5 subjects who meet the inclusion criteria. The dialysis sessions will be monitored and measurements from both device and patients will be recorded. Each session will last for 4 hours. Samples from both device and patients will be collected to determine safety and efficacy parameters. The adverse events log will also be maintained and addressed accordingly. The study will be completed after meeting all the required standards and documentation are also closed. |
| 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 RxT 17 HD.
This dialysis sessions will be a total of 15 sessions on 5 subjects who meet the inclusion criteria. The dialysis sessions will be monitored and measurements from both device and patients will be recorded. Each session will last for 4 hours.
Samples from both device and patients will be collected to determine safety and efficacy parameters.
The adverse events log will also be maintained and addressed accordingly. The study will be completed after meeting all the required standards and documentation are also closed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing and competent to sign the approved informed consent.
2.Patient must be at least 21 years of age or older.
3.Patient must weigh between 40 and 100kg, inclusive.
4.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.
5.Vascular access must be through a functioning arteriovenous fistula (AVF) with no thrombolytic therapy or clotting of the AVF within the past 4 weeks.
6.Willing to comply with the requirements of experimental treatment with the follow-up after 24 hours.
7.Expected survival of no less than 6 months.
8.Consent to allow review of their medical records by the investigators, and monitors.
9.Hemoglobin level greater than or equal to 9.0 g per dL prior to hemodialysis treatment.
|
|
| ExclusionCriteria |
| Details |
1.Anticipating or scheduled for a living related donor kidney transplant in less than 2 months.
2.History (within the 12 weeks prior to the study) of cardiovascular events including.
Unstable angina
Myocardial Infarction
Stroke
3.Clinical Significant Arrhythmia.
4.Life threatening arrhythmia within the past 30 days.
5.Severe intra-dialytic hypotension within the last 30 days.
6.Shock within the last 30 days.
7. Hemodynamic instability as demonstrated by repeated episodes of hypotension or hypertension requiring intervention by dialysis personnel or representing a present hazard to the patient.
8.Seizure disorder requiring active treatment for a seizure episode during the last 6 months.
9.Major Surgery (excluding vascular access surgery) within the past 30 days.
10.Currently receiving intravenous antibiotic therapy for systemic infection.
11. Clinical evidence of metastatic malignancy, receiving radiation or chemotherapy, within the past 365 days.
12.Active bleeding
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety and efficacy of HD (Hemodialysis) |
4 hours per session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subject vital signs as a Measure of Safety and Tolerability.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Blood electrolytes as a Measure of Safety and Efficacy.
Dialysate toxin load as a Measure of Safety and Tolerability.
Satisfaction survey as a Measure of Safety and Tolerability.
Blood urea levels.
Dialysate Urea Levels.
Blood creatinine levels.
Dialysate creatinine levels.
Volume of spent dialysate. |
4 hours |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2018 |
| 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)
|
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, non -randomised, open label, crossover, interventional study designed to provide preliminary data on human use of the first Indian hemodialysis machine(Renalyx RxT17). Five stable subjects with CKD V (Chronic Kidney Disease, Stage V), currently receiving twice weekly intermittent hemodialysis (HD) treatment via Arterio-Venous fistula as vascular access, will be studied, while Fresenius 4008S will be the comparator whose base line values will be used as a bench mark. This study is being conducted to obtain the required approval for the device to be legally commercialised. The development of this device within India is to potentially respond to the unmet public health needs of CKD patients. It is expected to improve the outcomes, reduce costs and provide treatment access to patients in end stage renal disease state, especially in rural India and developing countries. |