Clinical trial • Not applicable • Nephrology
MANNITOL for End-stage renal disease | Kidney transplantation
Not applicable trial of MANNITOL for End-stage renal disease | Kidney transplantation.
Overview
- Trial Therapeutic Area
- Nephrology
- Trial Disease
- End-stage renal disease | Kidney transplantation
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 03-02-2025
- First CTIS Authorization Date
- 07-04-2025
Trial design
Randomised, comparator arm: normal saline (placebo/comparator), intravenous solution; max total dose 200 ml (dose uom ml), route: intravenous. test arm: mannitol (solution for infusion), intravenous; max total dose 200 ml (dose uom ml), route: intravenous. further dosing schedule details refer to protocol/smpc documents (not specified in ctis record).-controlled Not applicable trial across 1 site in Finland.
- Randomised
- Yes
- Comparator
- Comparator arm: Normal saline (placebo/comparator), intravenous solution; max total dose 200 ml (dose UOM ml), route: intravenous. Test arm: Mannitol (solution for infusion), intravenous; max total dose 200 ml (dose UOM ml), route: intravenous. Further dosing schedule details refer to protocol/SmPC documents (not specified in CTIS record).
- Target Sample Size
- 466
- Trial Duration For Participant
- 90
Eligibility
Recruits 466 No vulnerable population selected (isVulnerablePopulationSelected=false). Consent must be obtained from the kidney recipient (exclusion criterion: "No informed consent from kidney recipient."). Informed consent documents available (titles include Informed Consent_EN, Informed Consent_FI, Informed Consent_SV)..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). Consent must be obtained from the kidney recipient (exclusion criterion: "No informed consent from kidney recipient."). Informed consent documents available (titles include Informed Consent_EN, Informed Consent_FI, Informed Consent_SV).
Inclusion criteria
- {"criterion_text":"- Patients receiving a kidney allograft from adult brain-dead donor."}
Exclusion criteria
- {"criterion_text":"- Recipient or donor age under 18 years.\n- No informed consent from kidney recipient.\n- Mannitol allergy\n- Pre-emptive kidney transplantation - patient has not yet been to dialysis"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Days to kidney function (see trial protocol)","definition_or_measurement_approach":"Refer to trial protocol (CTIS entry: \"Days to kidney function (see trial protocol)\"). No further definition or measurement details provided in the CTIS record."}
Secondary endpoints
- {"endpoint_text":"- Delayed kidney graft function (DGF)","definition_or_measurement_approach":"Not specified in CTIS entry; endpoint listed as \"Delayed kidney graft function (DGF)\"."}
- {"endpoint_text":"- Biopsy-proven acute kidney graft rejection within 3 months","definition_or_measurement_approach":"Endpoint specifies biopsy-proven rejection within 3 months; measurement approach not further detailed in CTIS record."}
- {"endpoint_text":"- Estimated glomerular filtration rate (eGFR) at 7 days, 1 month and 3 months","definition_or_measurement_approach":"eGFR measured at specified timepoints (7 days, 1 month, 3 months); further measurement details not provided in CTIS record."}
Recruitment
- Planned Sample Size
- 466
- Recruitment Window Months
- 285
- Consent Approach
- Informed consent must be obtained from the kidney recipient (exclusion criterion: "No informed consent from kidney recipient."). Participant information and informed consent forms are available (documents listed: Subject information and informed consent form; Informed Consent_EN; Informed Consent_FI; Informed Consent_SV). Participants under 18 are excluded.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 466
Finland
- Earliest CTIS Part Ii Submission Date
- 20-03-2025
- Latest Decision Or Authorization Date
- 07-04-2025
- Processing Time Days
- 18
- Number Of Sites
- 1
- Number Of Participants
- 466
Sites
- Site Name
- HUS-Yhtymae (Stenbackinkatu 9, Helsinki)
- Department Name
- Transplant and Liver Surgery
- Principal Investigator Name
- Ville Sallinen
- Principal Investigator Email
- ville.sallinen@hus.fi
- Contact Person Name
- Ville Sallinen
- Contact Person Email
- ville.sallinen@hus.fi
- Number Of Participants
- 466
Sponsor
Primary sponsor
- Full Name
- HUS-Yhtymae
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- MANNITOL
- Active Substance
- MANNITOL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- SmPC provided; approved/marketed medication (as per trial justification 'Low interventional clinical trial with approved medication' and SmPC document present)
- Maximum Dose
- 200 ml
- Investigational Product Name
- Normal saline
- Active Substance
- Normal saline (solvent/diluting agent)
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- SmPC provided (saline SmPC document present); marketed product
- Maximum Dose
- 200 ml
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