ElucidatiNg Immunosuppressant pharmacokinetic variabilities by investigating Gut Microbiota modulations After kidney transplantation - ENIGMA
Phase 1
- Conditions
- Chronic renal failureMedDRA version: 21.1Level: LLTClassification code: 10077912Term: Renal retransplantation Class: 10042613MedDRA version: 21.1Level: LLTClassification code: 10009119Term: Chronic renal failure Class: 10038359Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Registration Number
- CTIS2023-508335-31-00
- Lead Sponsor
- niversite Catholique de Louvain
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
(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
Exclusion Criteria
(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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method