BridgeMD
New treatment option for End Stage Kidney Disease
Official title Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants
ClinicalTrials.gov ID: NCT06613568
What this study is testing
- What it's testing
- The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Are between 18 and 80 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)...
- Have a well-functioning and stable vascular access (tunneled central venous catheter arteriovenous fistula, or graft) that allows a blood flow of at...
- Can successfully complete a Skills and Comprehension Assessment with a Care Partner prior to the completion of the Training Period.
You likely can't join if
- 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...
- Persistent pre-dialysis sitting SBP \< 100 mmHg despite medical therapy,
- Nadir intradialytic Systolic Blood Pressure (SBP) \< 90 mmHg, if Subject's pre-HD SBP \< 160 mmHg
- 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
See the full eligibility criteria
- Are between 18 and 80 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...
- 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 Screening
- Can successfully complete a Skills and Comprehension Assessment with a Care Partner prior to the completion of the Training Period.
- 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:
- Persistent pre-dialysis sitting SBP \< 100 mmHg despite medical therapy,
- Nadir intradialytic Systolic Blood Pressure (SBP) \< 90 mmHg, if Subject's pre-HD SBP \< 160 mmHg
- 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
- Participant had an average ultrafiltration rate \> 13 mL/kg/hour during the last 2 weeks prior to Screening, per medical records.
- Had a significant cardiovascular adverse event within the last 90 days prior to Screening.
The study team makes the final eligibility decision.
Where it's taking place
- San Dimas, California, United States
- New Hyde Park, New York, United States
- Knoxville, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Dimas, California, United States; New Hyde Park, New York, United States; Knoxville, Tennessee, United States; Houston, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.