Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
27
Countries
1
Sites
1
Organ transplantation
Assess oral bioequivalence of generic Tac and MMF in kidney transplant recipients at steady-state.
Key facts
- Sponsor
- Oslo University Hospital HF
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 4 Aug 2025 → 13 Nov 2025
- Decision date (initial)
- 2025-07-04
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Oslo University Hospital
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Bioequivalence, Pharmacokinetic
Assess oral bioequivalence of generic Tac and MMF in kidney transplant recipients at steady-state.
Secondary objectives 2
- Investigate direct and indirect effects of gut microbiota on Tac and MMF pharmacokinetics
- Update current population pharmacokinetic models by including data on generic products (if bioequivalent)
Conditions and MedDRA coding
Organ transplantation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10023438 | Kidney transplant | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- • Kidney transplant recipients on stable immunosuppressive therapy for the last two weeks
- • Immunosuppressive drug regimen containing Prograf® (tacrolimus twice daily), CellCept® (mycophenolate mofetil twice daily).
- • Above 18 years of age.
- • Able to comply with the medical treatment on their own.
- • Signed informed consent.
Exclusion criteria 8
- • Recent (1 month) rejection episode of the kidney graft treated with methylprednisolone.
- • Ongoing acute infectious disease, including any eventual treatment for the infection, that may influence drug PK.
- • Concomitant treatment with interacting drugs such as (but not limited to): cyclosporine, oral calcium supplements, diltiazem, verapamil, fenytoin, carbamazapin, fluconazole, ketoconazole, vorikonazole, erythromycin, clarithromycin, ritonavir, cholestyramine, rifampicin, ciprofloxacin, vancomycin, amoxicillin/clavulanic acid, cholestyramine, rifampicin, ciprofloxacin, vancomycin, amoxicillin/clavulanic acid.
- • Concomitant anti-coagulation treatment that affects capillary finger-prick sampling.
- • Severe diarrhea.
- • Women who are breastfeeding, pregnant patients or women of childbearing potential (WOCBP) not on highly effective contraception (see section 6.7 for details).
- • Severe medical condition that may affect drug metabolism, transportation and therefore study outcomes.
- • Hypersensitivity to the active substances or any of the excipients of the study drugs.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- AUC0-12 and Cmax of Tac and MPA test:reference (according to EMA bioequivalence guidelines).
Secondary endpoints 1
- Tac and MMF pharmacokinetic parameters and variables such as AUC0-12, Cmax, C0, C12, CL/F, popPK model parameters, metagenomic feces analyses, feces derived ex vivo drug conversion rates.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Tacrolimus Ascend 1 mg Hartkapseln
PRD11013201 · Product
- Active substance
- Tacrolimus
- Substance synonyms
- TACROLIMUS ANHYDROUS
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 420 mg milligram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- 7000303.00.00
- MA holder
- ASCEND GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mycophenolate Mofetil Accord 250 mg kapselit
PRD11134327 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 3 g gram(s)
- Max total dose
- 42 g gram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- 24747
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
CellCept 500 mg film-coated tablets
PRD2153969 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 3 g gram(s)
- Max total dose
- 45 g gram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- EU/1/96/005/004
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10226711 · Product
- Active substance
- Tacrolimus
- Substance synonyms
- TACROLIMUS ANHYDROUS
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 2 Week(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
Oslo University Hospital HF
- Sponsor organisation
- Oslo University Hospital HF
- Address
- Taarnbygget, Kirkeveien 166 Kirkeveien 166
- City
- Oslo
- Postcode
- 0450
- Country
- Norway
Scientific contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Anders Åsberg
Public contact point
- Organisation
- Oslo University Hospital HF
- Contact name
- Anders Åsberg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ended | 27 | 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 |
|---|---|---|---|---|---|
| Norway | 2025-08-04 | 2025-11-13 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-97175
- Sponsor became aware
- 2025-08-29
- Date of breach
- 2025-08-27
- Submission date
- 2025-09-10
- Member states concerned
- Norway
- Categories
- Protocol
- Areas impacted
- Subject safety, Data reliability or robustness
- Benefit-risk balance changed
- No
- Description
- Some Tacrolimus Ascend capsules break when taken out from blister pack.
Will potentially affect the bioequivalence endpoint if patients do not get the right dose from broken capsules.
Will potentially result in too low systemic exposure of tacrolimus if the patients do not take a new capsule. - Sponsor actions
- Contacted the product owner about the problem.
Patients are from then informed to note when this happens and take a new capsule. Patients are also informed to report number of capsules broken at the next visit.
Patients are equipped with more capsules to cover for a random breakage.
Number of broken capsules are registered in eCRF
| Organisation | City | Country | Type |
|---|---|---|---|
| Oslo University Hospital HF | Oslo | Norway | Sponsor (non commercial) |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-521800-22-00 | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC CellCept_20250414 | 0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC MMF Accord_20250623 | 0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Prograf_20250414 | 0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tacrolimus Ascend_20250623 | 0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO 2025-521800-22-00 | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-16 | Norway | Acceptable 2025-07-03
|
2025-07-04 |