Overview
Sponsor-declared trial summary
End-stage renal disease. Kidney transplantation.
To define if mannitol can be used to improve the results of kidney transplantation by reducing delayed graft function.
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 13 Nov 2025 → ongoing
- Decision date (initial)
- 2025-04-07
- 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: Therapy, Efficacy
To define if mannitol can be used to improve the results of kidney transplantation by reducing delayed graft function.
Secondary objectives 2
- To define if the use of mannitol decreases early kidney graft rejections-
- To define if the use of mannitol improves kidney graft survival.
Conditions and MedDRA coding
End-stage renal disease. Kidney transplantation.
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518817-24-00 | Mannitol versus normal saline in brain death donors and recipients of kidney allograft on delayed graft function (MAVERICK) – A double-blinded, placebo-controlled randomized clinical trial | HUS-Yhtymae |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients receiving a kidney allograft from adult brain-dead donor.
Exclusion criteria 4
- Recipient or donor age under 18 years.
- No informed consent from kidney recipient.
- Mannitol allergy
- Pre-emptive kidney transplantation - patient has not yet been to dialysis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Days to kidney function (see trial protocol)
Secondary endpoints 3
- Delayed kidney graft function (DGF)
- Biopsy-proven acute kidney graft rejection within 3 months
- Estimated glomerular filtration rate (eGFR) at 7 days, 1 month and 3 months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB03087MIG · Substance
- Active substance
- Mannitol
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 ml millilitre(s)
- Max total dose
- 200 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
-
V07AB · Product
- Pharmaceutical form
- PHF00017MIG
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 ml millilitre(s)
- Max total dose
- 200 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V07AB — SOLVENTS AND DILUTING AGENTS, INCL. IRRIGATING SOLUTIONS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Stenbackinkatu 9
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Ville Sallinen
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Ville Sallinen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 466 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2025-11-13 | 2025-11-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Clinical Trial Protocol Maverick CTIS | 1 |
| Protocol (for publication) | Clinical Trial Protocol Maverick Revised 122024 | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements with Finnish answers | 1 |
| Subject information and informed consent form (for publication) | Informed Consent_EN | 1 |
| Subject information and informed consent form (for publication) | Informed Consent_FI | 1 |
| Subject information and informed consent form (for publication) | Informed Consent_SV | 1 |
| Subject information and informed consent form (for publication) | MAVERICK_tutkimustiedote_FI_V2_REVISED | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Mannitol smpc | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Saline smpc | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-03 | Finland | Acceptable 2025-02-12
|
2025-04-07 |