Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruitment pending
Participants planned
66
Countries
1
Sites
1
Vaccination response
To compare uncensored graft survival in low-risk kidney transplant recipients on tacrolimus monotherapy versus dual regimen with tacrolimus and mycophenolate mofetil.
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
- Phenomena and Processes [G] - Immune system processes [G12]
- Decision date (initial)
- 2025-01-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Erasmus MC Rotterdam
External identifiers
- EU CT number
- 2024-513394-42-01
- EudraCT number
- 2019-001854-24
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To compare uncensored graft survival in low-risk kidney transplant recipients on tacrolimus monotherapy versus dual regimen with tacrolimus and mycophenolate mofetil.
Secondary objectives 6
- 1. To compare long-term outcomes in low-risk kidney transplant recipients on tacrolimus monotherapy versus dual regimen with tacrolimus and mycophenolate mofetil. a. Renal function and proteinuria. b. Patient survival. c. Rejection episodes. d. Infectious complications. e. Malignancy i. Skin ii. Non-skin.
- 2. To investigate the incidence and course of donor-specific antibodies in low-risk kidney transplant recipients beyond one year after transplantation (TAC vs TAC/MMF comparison).
- 3. To investigate protective antibody responses after pneumococcal vaccination in patients using tacrolimus versus tacrolimus/ mycophenolate mofetil (TAC vs TAC/MMF comparison). The persistence of this vaccination response 3 and 5 years after vaccination. The boosting effect of a repeated pneumococcal vaccination response five years after initial vaccination. The persistence of this boosted response one year after re-vaccination.
- 4. The persistence of this vaccination response 3 and 5 years after vaccination.
- 5. The boosting effect of a repeated pneumococcal vaccination response five years after initial vaccination.
- 6. The persistence of this boosted response one year after re-vaccination.
Conditions and MedDRA coding
Vaccination response
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Intervention period (6 years after kidney transplantation) This is a single-center investigator initiated trial with an open-label treatment
|
Not Applicable | None |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-513394-42-00 | Long-term outcomes in immunologically low-risk kidney transplant recipients using tacrolimus | Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) |
| 2014-001372-66 | Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study., Tacrolimus monotherapie bij niertransplantatie patiënten met een immunologisch laag risico: een gerandomiseerde, gecontroleerde pilot studie., Tacrolimus monotherapie bij niertransplantatie patiënten met een immunologisch laag risico: een gerandomiseerde, gecontroleerde pilot studie. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: - recipient of a kidney transplant who has participated in the study: ‘Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study’, NL46834.078.14. - able to give written informed consent
Exclusion criteria 1
- A potential subject who is unable to give written informed consent will be excluded from participation in this study:
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- a. Renal function and proteinuria. (creatinin and CKD-EPI; urine spot protein/ creatinine) b. Patient survival. c. Rejection episodes. d. Infectious complications: opportunistic infections, use of antibiotics. e. Malignancy o Skin (diagnosed via routine dermatology check-up) o Non-skin.
Secondary endpoints 2
- Determination of donor-specific antibodies using Luminex single-antigen beads 4, 6 and 10 years after transplantation.
- Quantification of pneumococcal vaccination response 3 and 5 years after pneumococcal vaccination (year 4 and 6 after kidney transplantation) with the 23-serotype polyvalent pneumococcal vaccine; and 3 weeks and one year after booster vaccination 5 years after the initial vaccination.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Pneumovax 23, oplossing voor injectie in een voorgevulde spuit Pneumokokkenpolysacharidevaccin
PRD4585845 · Product
- Active substance
- Pneumococcal Polysaccharide Serotype 4
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 120 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
- Marketing authorisation
- RVG 115340
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Netherlands
- 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
- A.E.Weerd de
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- A.E.Weerd de
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 66 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Internal Medicine, Dr. Molewaterplein 60, 3015 GJ, Rotterdam
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol_2024-513394-42-01 | 4 |
| Recruitment arrangements (for publication) | K1_Blanc document Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_2024-513394-42-01 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pneumovax 23 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-07 | Netherlands | Acceptable 2025-01-27
|
2025-01-27 |