Overview
Sponsor-declared trial summary
Chronic renal failure
The primary aim of our clinical study is to identify staging biomarkers of immunosuppressant (mainly Tacrolimus and mycophenolate mofetil) pharmacokinetic variability by investigating the gut microbiota modulations and physiological changes after kidney transplantation.
Key facts
- Sponsor
- Universite Catholique de Louvain
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 2 Sep 2024 → ongoing
- Decision date (initial)
- 2024-03-18
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Pharmacokinetic, Pharmacodynamic
The primary aim of our clinical study is to identify staging biomarkers of immunosuppressant (mainly Tacrolimus and mycophenolate mofetil) pharmacokinetic variability by investigating the gut microbiota modulations and physiological changes after kidney transplantation.
Conditions and MedDRA coding
Chronic renal failure
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10077912 | Renal retransplantation | 10042613 |
| 21.1 | LLT | 10009119 | Chronic renal failure | 10038359 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- (i) diagnosis of chronic renal failure
- (ii) planned for a kidney transplantation from a living-donor kidney
- (iii) followed at Cliniques universitaires Saint-Luc
- (iv) immunosuppressive treatment includes a combination of Tacrolimus (Advagraft) and mycophenolate mofetil (Cellcept)
- (v) aged between 18 and 75 years old at time of inclusion.
- (vi) BMI ranging from 18 to 35 kg/m2
- (viii) not being pregnant
- (viiii) able to speak and to understand French
Exclusion criteria 6
- (i) diagnosis of inflammatory bowel disease (IBD)
- (ii) having undergone or planed for bariatric surgery
- (iii) alcohol or drug addiction
- (iv) BMI lower than 18 or > than 35 kg/m2
- (v) not able to provide informed consent
- (vi) pregnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Immunosuppressive drug pharmacokinetic parameters, including tacrolimus, mycophenolic acid (the active moiety of mycophenolate mofetil) and glucuronides (MPA-glucuronide and acyl-MPA-glucuronide). Microbiota composition and function. Antibiotic pharmacokinetics
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SUB23141 · Substance
- Active substance
- Tacrolimus Monohydrate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.20 mg/kg milligram(s)/kilogram
- Max total dose
- 0.30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 5200 Week(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
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 5200 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB23141 · Substance
- Active substance
- Tacrolimus Monohydrate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.20 mg/kg milligram(s)/kilogram
- Max total dose
- 0.30 mg/kg milligram(s)/kilogram
- Max treatment duration
- 5200 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB23141 · Substance
- Active substance
- Tacrolimus Monohydrate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.20 mg/kg milligram(s)/kilogram
- Max total dose
- 030 mg/kg milligram(s)/kilogram
- Max treatment duration
- 5200 Week(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
Universite Catholique de Louvain
- Sponsor organisation
- Universite Catholique de Louvain
- Address
- Place De L'Universite 1
- City
- Ottignies-Louvain-La-Neuve
- Postcode
- 1348
- Country
- Belgium
Scientific contact point
- Organisation
- Universite Catholique de Louvain
- Contact name
- Laure Elens
Public contact point
- Organisation
- Universite Catholique de Louvain
- Contact name
- Laure Elens
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 50 | 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 |
|---|---|---|---|---|---|
| Belgium | 2024-09-02 | 2024-09-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1-Protocol_2023-508335-31-00_public with track changes | 4 |
| Protocol (for publication) | D1-Protocol_2023-508335-31-00_public_clean | 4 |
| Protocol (for publication) | D10_instructions blood collection VAMS | 1 |
| Protocol (for publication) | D11_FFQ_V1 | 1 |
| Protocol (for publication) | D4_Patient facing document_drug diary | 1 |
| Protocol (for publication) | D4_Patient facing document_food diary | 1 |
| Protocol (for publication) | D5_Monitoring plan_2023-508335-31-00_public | 1 |
| Protocol (for publication) | D6_Data management plan_2023-508335-31-00_public | 1 |
| Protocol (for publication) | D7_Patient flyer | 1 |
| Protocol (for publication) | D8_Storyboard video ENIGMA | 1 |
| Protocol (for publication) | D9_Storyboard video VAMS | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF receiver V4_clean | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC_advagraf | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC_advagraf | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC_advagraf | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC_cellcept | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE FR NL GER_2023-508335-31-00 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-27 | Belgium | Acceptable with conditions 2024-03-11
|
2024-03-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-11 | Belgium | Acceptable 2024-05-24
|
2024-05-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-08 | Belgium | Acceptable 2025-10-23
|
2025-10-27 |