Clinical trial • Not applicable • Nephrology|Immunology

TACROLIMUS MONOHYDRATE for Chronic kidney disease|Kidney transplantation

Not applicable trial of TACROLIMUS MONOHYDRATE for Chronic kidney disease|Kidney transplantation. 50 participants.

Overview

Trial Therapeutic Area
Nephrology|Immunology
Trial Disease
Chronic kidney disease|Kidney transplantation
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-11-2023
First CTIS Authorization Date
18-03-2024

Trial design

Not applicable trial across 1 site in Belgium.

Target Sample Size
50

Eligibility

Recruits 50 Vulnerable population not selected. Participants unable to provide informed consent are excluded ("(v) not able to provide informed consent"). Only adults aged 18-75 are eligible; no children/minors included. Consent provided by participant; subject information and ICF document available..

Pregnancy Exclusion
(viii) not being pregnant
Vulnerable Population
Vulnerable population not selected. Participants unable to provide informed consent are excluded ("(v) not able to provide informed consent"). Only adults aged 18-75 are eligible; no children/minors included. Consent provided by participant; subject information and ICF document available.

Inclusion criteria

  • {"criterion_text":"- (i)\tdiagnosis of chronic renal failure"}
  • {"criterion_text":"- (ii)\tplanned for a kidney transplantation from a living-donor kidney"}
  • {"criterion_text":"- (iii)\tfollowed at Cliniques universitaires Saint-Luc"}
  • {"criterion_text":"- (iv)\timmunosuppressive treatment includes a combination of Tacrolimus (Advagraft) and mycophenolate mofetil (Cellcept)"}
  • {"criterion_text":"- (v)\taged between 18 and 75 years old at time of inclusion."}
  • {"criterion_text":"- (vi)\tBMI ranging from 18 to 35 kg/m2"}
  • {"criterion_text":"- (viii)\tnot being pregnant"}
  • {"criterion_text":"- (viiii) able to speak and to understand French"}

Exclusion criteria

  • {"criterion_text":"- (i)\tdiagnosis of inflammatory bowel disease (IBD)"}
  • {"criterion_text":"- (ii)\thaving undergone or planed for bariatric surgery"}
  • {"criterion_text":"- (iii)\talcohol or drug addiction"}
  • {"criterion_text":"- (iv)\tBMI lower than 18 or > than 35 kg/m2"}
  • {"criterion_text":"- (v)\tnot able to provide informed consent"}
  • {"criterion_text":"- (vi)\tpregnancy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
50
Recruitment Window Months
58
Consent Approach
Written informed consent provided by the participant (adult, 18-75). Subjects must be able to speak and understand French. Participants unable to provide informed consent are excluded. Subject information and ICF document present (L1_ICF receiver V4_clean).

Geography

Total Number Of Sites
1
Total Number Of Participants
50

Belgium

Earliest CTIS Part Ii Submission Date
12-02-2024
Latest Decision Or Authorization Date
27-10-2025
Processing Time Days
623
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
nephrology
Principal Investigator Name
Arnaud Devresse
Principal Investigator Email
arnaud.devresse@saintluc.uclouvain.be
Contact Person Name
Arnaud Devresse
Number Of Participants
50

Sponsor

Primary sponsor

Full Name
Universite Catholique de Louvain
Organisation Type
Educational Institution
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
TACROLIMUS MONOHYDRATE
Active Substance
TACROLIMUS MONOHYDRATE
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Market authorised
Maximum Dose
0.20 mg/kg (daily max reported)
Investigational Product Name
MYCOPHENOLATE MOFETIL
Active Substance
MYCOPHENOLATE MOFETIL
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Market authorised
Maximum Dose
2 g (daily max reported)
Combination Treatment
Yes

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