Immunosuppressive Drugs and Gut Microbiome: Pharmacokinetic- and Microbiome Diversity Effects
Phase 1
- Conditions
- Kidney transplantationMedDRA version: 20.0Level: LLTClassification code: 10023438Term: Kidney transplant Class: 10042613Therapeutic area: Phenomena and Processes [G] - Microbiological Phenomena [G06]
- Registration Number
- CTIS2023-510486-10-00
- Lead Sponsor
- Oslo University Hospital HF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
De novo, standard risk kidney (only) transplant recipients., Patients scheduled to receive tacrolimus and mycophenolate mofetil as part of their immunosuppressive therapy following transplantation (clinical decision not influenced by this study)., First kidney transplant only., Recipients of kidney from deceased or living adult donor, ABO-compatible transplantation, PRA =20%, DSA negative, Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations.
Exclusion Criteria
Pregnant or lactating female patients.
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