Overview
Sponsor-declared trial summary
lung transplantation
To compare absolute difference in renal function expressed as absolute difference in eGFR, at 2 years compared to baseline, calculated by the 2012 CKD-EPI creatinine–cystatin C equation in patients treated with IR or LCP tacrolimus.
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2025-01-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518639-12-00
- EudraCT number
- 2020-000760-36
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To compare absolute difference in renal function expressed as absolute difference in eGFR,
at 2 years compared to baseline, calculated by the 2012 CKD-EPI creatinine–cystatin C
equation in patients treated with IR or LCP tacrolimus.
Secondary objectives 1
- The key secondary objective is graft function. Other secondary endpoints are changes in known side effects of calcineurin inhibitors i.e. hypertension, new onset diabetes mellitus and neurotoxicity.
Conditions and MedDRA coding
lung transplantation
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- For both the de novo and conversion study: - Single or bilateral lung transplantation - Age > 18 years - On twice daily tacrolimus with stable trough levels in target range - Written informed consent - Participant in the TransplantLines biobank study in the UMCG Additional criteria for: - De novo study: De novo lung transplant patients are recruited before transplantation, and subsequently in all patients put on tacrolimus intravenously. Participants can be randomized when they are on stable daily dosage. - Conversion study: o At least one year after lung transplantation with a stable clinical course and lung function o eGFR >30ml/min*1.73m2 calculated with the CKD-EPI formula
Exclusion criteria 1
- Administration of mTOR inhibitors; everolimus, sirolimus - Quadruple immunosuppression - Renal transplantation - The subject has any disease or condition that might interfere with completion of this study or reaching the primary endpoint (e.g., life expectancy of <3 years, renal replacement therapy at start study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Kidney function
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Envarsus 0.75 mg prolonged-release tablets
PRD11085939 · Product
- Active substance
- Tacrolimus
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- PLGB 08829/0183
- MA holder
- CHIESI LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD10226711 · Product
- Active substance
- Tacrolimus
- Substance synonyms
- TACROLIMUS ANHYDROUS
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 8912/2016/02
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- C.T.Gan
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- C.T.Gan
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 140 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 20245186391200 | 5 |
| Recruitment arrangements (for publication) | Blanc document | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF 2024-518639-12-00 | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Envarsus | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Prograft | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | Netherlands | Acceptable 2025-01-28
|
2025-01-28 |