lung transplant recipients lung transplantation
Conditions
Interventions
LCP tacrolimus is the investigational drug, and will be compared to IR
tacrolimus which is standard therapy after lung transplantation.
LCP tacrolimus
lung transplantation
toxicity
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: For both the de novo and conversion study: - Participant in Transplanlines biobank study UMCG - Single or bilateral lung transplantation - Age > 18 years - On twice daily tacrolimus with stable trough levels in target range - Written informed consent 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: o At least one year after lung transplantation with a stable clinical course o eGFR >30ml/min*1.73m2 calculated with the CKD-EPI formula
Exclusion criteria
Exclusion criteria: - Administration of mTOR inhibitors; everolimus, sirolimus - Quadruple immunosuppression - Also renal transplant recipient Additional criteria for: - Conversion study o Expected survival
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the absolute change in eGFR measured by cystatin C decline in patients treated with LCP tacrolimus compared to IR tacrolimus assessed by the absolute change in eGFR after 2 years. Cystatin C and creatinine will be used as a marker for eGFR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are additional toxicity analyses including renal function measured with plasma creatinine, creatinine clearance in 24 hours urine analysis, incidence of hypertension, incidence of new onset diabetes after transplantation (NODAT), neurotoxicity, transplant function, quality of life and pharmacogenetic properties for LCP tacrolimus metabolism in the lung transplant population. | — |
Countries
The Netherlands
Outcome results
None listed