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ElucidatiNg Immunosuppressant pharmacokinetic variabilities by investigating Gut Microbiota modulations After kidney transplantation - ENIGMA
EU CTIS ID: 2023-508335-31-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- (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
You likely can't join if
- (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
See the full eligibility 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
- (viii) not being pregnant
- (viiii) able to speak and to understand French
- (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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.