NL-OMON29263RecruitingNot Applicable
‘Randomized controlled prospEctiVe trial comparing extended-release with immediate-release tacrOlimus; reducing calcineurin inhibitor related toxicity in LUng TransplantatION patients’
niversity Medical Center Groningen (UMCG)0 sites150 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •For both the de novo and conversion study:
- •-Single or bilateral lung transplantation
- •-Age > 18 years
- •-On twice daily tacrolimus with stable trough levels in target range
- •-Written informed consent
- •-Participant in the TransplantLines biobank study in the UMCG
- •Additional criteria for:
- •-De novo study: De novo lung transplant patients are recruited before transplantation, and subsequently in all patients put on tacrolimus intravenously. Participants can be randomized when they are on stable daily dosage.
- •-Conversion study:
- •oAt least one year after lung transplantation with a stable clinical course, lung function and stable twice daily administered tacrolimus dosage for at least 3 months prior to conversion
- •oeGFR >30ml/min*1.73m2 calculated with the CKD-EPI formula
Exclusion Criteria
- •For both the de novo and conversion study:
- •--Administration of mTOR inhibitors; everolimus, sirolimus
- •-Quadruple immunosuppression
- •-Also renal transplant recipient
- •Additional criteria for:
- •-Conversion study
- •oExpected survival < 3 years
Investigators
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