Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
20
Countries
1
Sites
1
muscle protein turnover hemodialysis
To study the effect of IDPN on muscle protein synthesis in chronic hemodialysis patients and to characterize the hemodynamic effects of IDPN.
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Decision date (initial)
- 2025-10-27
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
To study the effect of IDPN on muscle protein synthesis in chronic hemodialysis patients and to characterize the hemodynamic effects of IDPN.
Conditions and MedDRA coding
muscle protein turnover hemodialysis
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-522111-42-00 | Long-term muscle synthetic effects of intradialytic parenteral nutrition in chronic hemodialysis patients | Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) |
| 2025-522111-42-01 | Long-term muscle synthetic effects of intradialytic parenteral nutrition in chronic hemodialysis patients | Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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
Exclusion criteria 1
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference in myofibrillar fractional synthetic rate during a one-week treatment with IDPN versus control
Secondary endpoints 1
- 1. Intradialytic forearm amino acid balance, 2. difference in the loss of amino acids in the dialysate during a one-week treatment with IDPN versus control period, 3. Effects of IDPN on intradialytic blood pressure and cardiac output.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP1002941 · ATC
- Active substance
- Valine
- Route of administration
- PARENTERAL
- Max daily dose
- 1000
- Max total dose
- 1000 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- B05BA10 — COMBINATIONS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Wesley Visser
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Wesley Visser
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Internal Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Amendement_C1_Protocol_2025-522111-42-00_Clean_12-01-2026 | 1.2 |
| Protocol (for publication) | Amendement_C1_Protocol_2025-522111-42-00_TC_12-01-2026 | 1.2 |
| Protocol (for publication) | D1_Protocol_2025-522111-42-00_Clean_06-10-2025 | 1.1 |
| Protocol (for publication) | D1_Protocol_2025-522111-42-00_Track changes_06-10-2025 | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_cleen | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Track changes | 1 |
| Subject information and informed consent form (for publication) | Amendement_CTR L1 SIS and ICF_Hoofdstudie_Clean | 1.3 |
| Subject information and informed consent form (for publication) | Amendement_CTR L1 SIS and ICF_Hoofdstudie_TC | 1.3 |
| Subject information and informed consent form (for publication) | Amendement_CTR L1 SIS and ICF_Pilot_Clean | 1.3 |
| Subject information and informed consent form (for publication) | Amendement_CTR L1 SIS and ICF_Pilot_TC | 1.3 |
| Subject information and informed consent form (for publication) | E1_ Proefpersoneninformatie LOTUS Studie_Clean 06102025docx | 1 |
| Subject information and informed consent form (for publication) | E1_ Proefpersoneninformatie LOTUS Studie_pilotfase_Clean 06102025 | 1 |
| Subject information and informed consent form (for publication) | E1_ Proefpersoneninformatie LOTUS Studie_TC 06102025docx | 1 |
| Subject information and informed consent form (for publication) | E1_Proefpersoneninformatie LOTUS Studie pilotfase Track Changes 06102025 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Olimel | 1 |
| Synopsis of the protocol (for publication) | D1_EN_Protocol synopsis_2025-522111-42 | 1 |
| Synopsis of the protocol (for publication) | D1_NL-NL_Protocol synopsis_2025-522111-42-00_RFI06-10-25 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-11 | Netherlands | Acceptable 2025-10-27
|
2025-10-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-12 | Netherlands | Acceptable 2025-10-27
|
2026-01-12 |