Authorised Therapeutic use (Phase IV) muscle protein turnover hemodialysis

LOTUS

EU CTIS ID: 2025-522111-42-02

What this study is testing

To study the effect of IDPN on muscle protein synthesis in chronic hemodialysis patients and to characterize the hemodynamic effects of IDPN.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • To be eligible to participate in this study, a participant must meet all the following criteria: - Age at least 18 years - Receiving HD treatment at least 3 months - Receiving HD treatment 3 times per week for at least 4 hours per session - 24-hour urine production < 100 mL - Adequate dialysis dose (eKt/V at least 1.2) - AV fistula with blood flow (measured invasively or by Doppler ultrasound) at least 750 mL/min

You likely can't join if

  • A potential subject who meets any of the following criteria will be excluded from participation in this study: - Occurrence of intradialytic hypotension in the last month, defined by systolic blood pressure < 90 mm Hg combined with a nursing intervention - Hospitalization < 3 months before inclusion - Active infection or inflammation at randomization - Use of oral or intravenous corticosteroids - Incapacitation - Patients who are not expected to be able to complete the study protocol (e.g., due to a planned kidney transplantation within the planned study time frame) - Pregnancy - Use of oral anticoagulants or antiplatelet agents that cannot be safely stopped during the study - Diabetes mellitus - AV fistula with recirculation

The study team makes the final eligibility decision.

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.