Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
304
Countries
1
Sites
3
kidney transplantation
Lowering the immune suppressive maintenance regimen in the elderly recipient thereby reducing infection-related mortality and morbidity
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
- Not possible to specify
- Trial duration
- 4 Aug 2025 → ongoing
- Decision date (initial)
- 2025-06-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Erasmus Medical Center · Chiesi Pharmaceuticals · Nierstichting Nederland
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
Lowering the immune suppressive maintenance regimen in the elderly recipient thereby reducing infection-related mortality and morbidity
Secondary objectives 1
- - quality of life - biopsy-proven rejection from time of randomization to end of follow-up at 3 years post-transplantation. - Assessment of de novo alloantibody formation as detected by a Luminex-based assay (6 months, 1,2 and 3 years after transplantation) - Assessment of the circulating alloreactive T cells in time (before, 1, 2 and 3 years after transplantation) - Graft function measured by eGFR and 24-hr urine collection - Patient and graft survival
Conditions and MedDRA coding
kidney transplantation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10074474 | Transplantation complications | 10022117 |
| 21.1 | LLT | 10077912 | Renal retransplantation | 10042613 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Tacrolimus monotherapy in elderly kidney transplant recipients A randomized trial of tacrolimus monotherapy compared to standard triple immune suppressive medication in elderly recipients of a kidney transplant to reduce infection-related mortality and improve quality of life; the TACMONO-XL study.
|
Randomised Controlled | None | standard regimen: Patients start with triple immune suppressive medication consisting of prednisone, MMF and tacrolimus after transplantation which is continued thereafter study regimen: Patients start with triple immune suppression but at 3 months after transplantation prednisone is tapered and stopped at 5 months. Starting at 6 months the MMF is tapered to stop at 9 months and patients thereafter continue with tacrolimus monotherapy. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - patients of 60 years or older receiving a deceased or living kidney transplant and at time of transplantation no donor-specific anti-HLA antibodies. - Re-transplantations are allowed when meeting the before mentioned criteria. - Patients have to give written informed consent to participate in the study.
Exclusion criteria 1
- - HLA-identical living-related transplantation - the presence of an immunological-mediated disease requiring immunosuppression - ABO-blood group incompatibility or positive CDC-test with the donor as performed at the HLA lab of the participating UMC - presence of donor-specific anti-HLA antibodies as defined by the Luminex assay (presence defined as MFI above background level) - combined liver/kidney or pancreas/kidney transplantation or previous organ transplantation other than kidney - participation in another clinical trial interfering with immune suppressive medication or risk of infection - not able to stop prednisone because of long-term use - eGFR <25 ml/min at month 3 - within the first 3 months after transplantation: any biopsy-proven rejection requiring T cell depletion or biopsy-proven antibody-mediated rejection - not able to provided written informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- - death by infectious disease - infectious burden defined as the number of infections requiring hospitalization and/or proven viral infections including cytomegalovirus and BK-virus replication within a follow-up of 3 years.
Secondary endpoints 1
- - quality of life - biopsy-proven rejection from time of randomization to end of follow-up at 3 years post-transplantation. - Assessment of de novo alloantibody formation as detected by a Luminex-based assay (6 months, 1,2 and 3 years after transplantation) - Assessment of the circulating alloreactive T cells in time (before, 1, 2 and 3 years after transplantation) - Graft function measured by eGFR and 24-hr urine collection - Patient and graft survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SUB10797MIG · Substance
- Active substance
- Tacrolimus
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 21.9 g gram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 11 g gram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2000 mg milligram(s)
- Max total dose
- 2190 g gram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- 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
- Michiel Betjes
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Michiel Betjes
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 304 | 3 |
| 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 | 2025-08-04 | 2025-08-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_CCMOClinicalTrialProtocol-TACmonoXLvs1_redacted | 1 |
| Protocol (for publication) | D1_CCMOClinicalTrialProtocol-TACmonoXLvs2_clean_redacted | 1 |
| Protocol (for publication) | D1_CCMOClinicalTrialProtocol-TACmonoXLvs2_clean_signed | 1 |
| Protocol (for publication) | D1_CCMOClinicalTrialProtocol-TACmonoXLvs2_marked_redacted | 1 |
| Recruitment arrangements (for publication) | K1_recruitment-arrangement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF -Dutch | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_Cellcept 500mg Film-Coated Tablets - Summary of Product Characteristics-SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_Envarsus-prolonged release tablets-SmPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_Prednisonetablets | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_Dutch | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol-synopsis-English | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-25 | Netherlands | Acceptable with conditions 2025-02-10
|
2025-06-06 |