VALINE, ARGININE GLUTAMATE, ALANINE, ARGININE, ISOLEUCINE, LEUCINE, METHIONINE, PHENYLALANINE, PROLINE, SERINE, THREONINE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE HYDROCHLORIDE MONOHYDRATE, POTASSIUM DIHYDROGEN PHOSPHATE, TRYPTOPHAN, POTASSIUM HYDROXIDE, SODIUM CHLORIDE, SODIUM HYDROXIDE, CALCIUM CHLORIDE DIHYDRATE, GLUCOSE MONOHYDRATE, LYSINE HYDROCHLORIDE, MAGNESIUM ACETATE TETRAHYDRATE, SODIUM ACETATE TRIHYDRATE for Muscle protein turnover | Chronic kidney disease on hemodialysis

Inclusion criteria

• {"criterion_text":"- Age at least 18 years\n- Receiving HD treatment at least 3 months\n- Receiving HD treatment 3 times per week for at least 4 hours per session\n- 24-hour urine production < 100 mL\n- Adequate dialysis dose (eKt/V at least 1.2)\n- AV fistula with blood flow (measured invasively or by Doppler ultrasound) at least 750 mL/min"}

Exclusion criteria

• {"criterion_text":"- Occurrence of intradialytic hypotension in the last month, defined by systolic blood pressure < 90 mm Hg combined with a nursing intervention\n- Hospitalization < 3 months before inclusion\n- Active infection or inflammation at randomization\n- Use of oral or intravenous corticosteroids \n- Incapacitation\n- 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)\n- Pregnancy\n- Use of oral anticoagulants or antiplatelet agents that cannot be safely stopped during the study\n- Diabetes mellitus\n- AV fistula with recirculation"}

Primary endpoints

• {"endpoint_text":"- Difference in myofibrillar fractional synthetic rate during a one-week treatment with IDPN versus control","definition_or_measurement_approach":"Measured as the myofibrillar fractional synthetic rate during a one-week treatment with intradialytic parenteral nutrition (IDPN) versus a control period without IDPN."}

Secondary endpoints

• {"endpoint_text":"- Intradialytic forearm amino acid balance\n- difference in the loss of amino acids in the dialysate during a one-week treatment with IDPN versus control period\n- Effects of IDPN on intradialytic blood pressure and cardiac output.","definition_or_measurement_approach":"Endpoints measured during the one-week treatment with IDPN versus a control period; includes forearm amino acid balance, amino acid loss in dialysate during one-week treatment, and intradialytic blood pressure and cardiac output measurements."}

Netherlands

Earliest CTIS Part Ii Submission Date

06-10-2025

Latest Decision Or Authorization Date

12-01-2026

Processing Time Days

98

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands