Interaction between bacteria in the intestines and immunosuppressive drugs

Phase 1

• Conditions: Kidney transplantation; MedDRA version: 20.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-002476-14-NO
• Lead Sponsor: Oslo University Hospital - Rikshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Last Update Posted: 8 July 2024

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.
?Adult patients.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

?Pregnant or lactating female patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified