Search / Trial NCT06613568

Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants

Launched by DIALITY INC. · Sep 23, 2024

Trial Information

Current as of October 09, 2024

Not yet recruiting

Keywords

Renal Disease Hemodialysis Complication Kidney Diseases Dialysis Renal Dialysis Hemodialysis, Home Renal Insufficiency Kidney Failure, Chronic

Description

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * Are between 18 and 75 years of age and Care Partner is at least 18 years of age at the time of signing consent
  • * Have a diagnosis of end stage kidney disease (ESKD) adequately treated by maintenance dialysis (defined as achieving a spKt/V ≥ 1.2 OR stdKt/V ≥ 2.1) and be deemed stable by their treating nephrologist prior to the end of the Run-In Period
  • * In the opinion of the Investigator, have a well-functioning and stable vascular access (tunneled central venous catheter arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml/min prior to the end of the Run-In Period
  • * In the opinion of the Investigator, can successfully complete a Skills Assessment with a Care Partner prior to the completion of the Training Period
  • Exclusion Criteria:
  • * Hgb level of \< 9 g/dL at Screening
  • * Symptomatic intradialytic hypotension requiring medical intervention (ultrafiltration turned off, bolus of fluid) in at least two treatments during the Run-In period defined as:
  • 1. Persistent pre-dialysis sitting SBP \< 100 mmHg despite medical therapy,
  • 2. Nadir intradialytic Systolic Blood Pressure (SBP) \< 90 mmHg, if Subject's pre-HD SBP \< 160 mmHg
  • 3. Nadir intradialytic SBP \< 100 mmHg if Subject's pre-HD SBP ≥ 160 mmHg
  • * Documented history of non-adherence to dialysis therapy that would prevent successful completion of the study

About Diality Inc.

Diality Inc. is an innovative clinical trial sponsor dedicated to advancing the development of transformative therapies through cutting-edge research and technology. With a focus on enhancing patient outcomes, Diality leverages a robust portfolio of clinical programs and partnerships to accelerate the delivery of novel treatments across various therapeutic areas. Committed to rigorous scientific standards and ethical practices, Diality fosters collaboration with healthcare professionals and regulatory bodies to ensure the highest quality of clinical trials, ultimately aiming to improve health care solutions for patients worldwide.

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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