Health Condition 1: null- 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.
Conditions
Sponsors
Renalyx Health Systems Pvt Ltd
Eligibility
Inclusion criteria
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. 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.
Exclusion criteria
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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy of HD (Hemodialysis)Timepoint: 4 hours per session | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 4 hours | — |
Countries
India
Contacts
Public ContactDr Kiran KK
Renalyx Health Systems Pvt. Ltd
Outcome results
None listed