Overview
Sponsor-declared trial summary
End stage kidney disease - Kidney transplantation donors receiving kidneys from donation after circulatory death (DCD).
To study whether exogenous alkaline phosphatase can prevent ischemia reperfusion injury in deceased donor kidney transplantation and will thereby decrease the duration of delayed graft function (DGF). DGF is defined as the need for dialysis that started within 7 days post-transplant, excluding single sessions for hyper…
Key facts
- Sponsor
- Stichting Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 22 May 2023 → ongoing
- Decision date (initial)
- 2024-11-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Health Holland B.V. and Alloksys Life Sciences
External identifiers
- EU CT number
- 2024-515480-66-01
- EudraCT number
- 2021-006767-14
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
To study whether exogenous alkaline phosphatase can prevent ischemia reperfusion
injury in deceased donor kidney transplantation and will thereby decrease the duration of
delayed graft function (DGF). DGF is defined as the need for dialysis that started within 7
days post-transplant, excluding single sessions for hyperkalemia.
Secondary objectives 12
- Decrease mean duration of hospitalization after kidney transplantation
- Decrease of incidence of persistent dialysis DGF (> 14 days)
- Decrease incidence of functional DGF and dialysis DGF
- Decrease duration of DGF using functional and dialysis definition and a combination of the two
- Improve fall of serum creatinine in the first week after transplantation
- Improve kidney perfusion contrast renography at day 6
- Improve creatinine clearance at 3 months and 1 year after transplantation
- Decrease proteinuria at 3 months and 1 year after transplantation
- Improve estimated renal glomerular filtration rate (eGFR) calculated with MDRD and the CKD-epi formula at 3 months and 1 year after transplantation
- Reduce primary non-function (defined as dialysis dependency or creatinine clearance <20ml/min at 3 months)
- Reduce incidence of biopsy proven rejection within one year follow-up period
- Improve all-cause mortality at day 28 and 90 and 1 year
Conditions and MedDRA coding
End stage kidney disease - Kidney transplantation donors receiving kidneys from donation after circulatory death (DCD).
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- Coded data will also be made available to a third party; Alloksys life sciences B.V. Only relevant patient baseline criteria and information related to the outcomes specified in this protocol will be provided to this third party. Personal data such as birth year will not be made available.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-515480-66-00 | Alkaline Phosphatase as treatment of Ischemia Reperfusion Injury to prevent delayed graft function | Stichting Amsterdam UMC |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients recipients of a donor awaiting cardiac death on the intensive care (definition of a donor cardiac death type III according to the ‘Maastricht classification’)
- Age >18
- Can give written informed consent
Exclusion criteria 3
- Strict vegetarians
- Vegans
- History of allergy to bovine proteins
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference between treatment and placebo group in delayed graft function (DGF) duration (in days) as measured on day 28. DGF is defined as need for dialysis within 7 days after transplantation, excluding single sessions for hyperkalemia. No need for dialysis will be registered as 0 days.
Secondary endpoints 12
- Mean duration of hospitalization after kidney transplantation
- Incidence of persistent dialysis DGF (> 14 days)
- Incidence of functional and dialysis DGF
- Duration of DGF using functional and dialysis definition and a combination of the two
- Dall of serum creatinine in the first week after transplantation
- Kidney perfusion contrast renography at day 6
- Creatinine clearance at 3 months and 1 year after transplantation
- Proteinuria at 3 months and 1 year after transplantation
- Estimated renal glomerular filtration rate (eGFR) calculated with MDRD and the CKD-epi formula at 3 months and 1 year after transplantation
- Primary non-function (defined as dialysis dependency or creatinine clearance <20ml/min at 3 months).
- Incidence of biopsy proven rejection within one year follow-up period.
- All-cause mortality at day 28 and 90 and 1 year.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11579023 · Product
- Active substance
- Alkaline Phosphatase, Bovine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 50000 IU international unit(s)
- Max total dose
- 75000 IU international unit(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AMSTERDAM UMC
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Amsterdam UMC
- Sponsor organisation
- Stichting Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- Liffert Vogt
Public contact point
- Organisation
- Stichting Amsterdam UMC
- Contact name
- Debby Roosblad
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 1 | 2 |
| 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 |
|---|---|---|---|---|---|
| Netherlands | 2023-05-22 | 2023-05-22 |
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) | D1_Protocol 2024-515480-66-01 CLEAN | 5 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description AMC CLEAN | 2.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description AMC TC | 2.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description CLEAN | 2.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF description LUMC | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-515480-66-01 Dutch | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-515480-66-01 english | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-09 | Netherlands | Acceptable 2024-11-04
|
2024-11-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-08 | Netherlands | Acceptable 2025-06-13
|
2025-06-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-11 | Netherlands | Acceptable | 2025-10-07 |