A clinical trial to study the safety and effectiveness of the first Indian dialysis machine.

Not yet recruiting

• Conditions: 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.

• Registration Number: CTRI/2018/02/011882
• Lead Sponsor: Renalyx Health Systems Pvt Ltd

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-02-13
• Study Start: 2018-02-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• 1.Patient willing and competent to sign the approved informed consent.
• 2.Patient must be at least 21 years of age or older.
• 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.

Exclusion Criteria

• 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.
• 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.
• Clinical evidence of metastatic malignancy, receiving radiation or chemotherapy, within the past 365 days.
• 12.Active bleeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of HD (Hemodialysis)	4 hours per session

Secondary Outcome Measures

Name	Time	Method
Subject vital signs as a Measure of Safety and Tolerability.	Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Trial Locations

Locations (1)

JSS Hospital; 🇮🇳 Mysore, KARNATAKA, India

JSS Hospital

🇮🇳Mysore, KARNATAKA, India

Dr Manjunath S Shetty

Principal investigator

9880739069

drmanjunathsshetty@yahoo.com