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The TwoPlus Study-Comparative Effectiveness of an Individualized Model of Hemodialysis vs. Conventional Hemodialysis

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
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Description

The purpose of this study is to compare clinical outcomes and health-related quality of life between an individualized hemodialysis prescription and conventional hemodialysis prescription in individuals requiring chronic hemodialysis who still have residual kidney function.  

Details

Protocol number CED000000872

Eligibility

Clinical Inclusion Criteria:

  1. Age ≥ 18 years 
  2. New-onset kidney dysfunction requiring dialysis (also known as end-stage kidney disease [ESKD] or end-stage renal disease [ESRD] or chronic kidney disease stage 5 on dialysis [CKD5D]) started on chronic, in-center HD, or anticipated to be started on chronic, in-center HD within the next 6 weeks
  3. Has received ≤18 sessions of intermittent HD (i.e., on HD for ≤6 weeks) at the time patient is approached for potential study participation

Residual Kidney Function Inclusion Criteria : 4) Kidney urea clearance ≥3.5 mL/min/1.73 m2

  1. Urine volume of ≥500 mL/24 h

Exclusion Criteria:

  1. Serum potassium ≥5. 8 mEq/L**

  2. Serum sodium ≤125 mEq/L**

  3. Serum bicarbonate level ≤17 mEq/L**

  4. Requirement or anticipated requirement of high-volume ultrafiltration **

  5. History of medical non-adherence that, in the opinion of the site investigators and/or treating provider, precludes safe study participation

  6. A medical condition that, in the opinion of the site investigators and/or treating providers, would jeopardize the safety of the participant

Lead researcher

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

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