lung transplantation
Conditions
Interventions
Randomising for LCP tacrolimus or IR tacrolimus
Sponsors
University Medical Center Groningen (UMCG)
Eligibility
Inclusion 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: o At 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 o eGFR >30ml/min*1.73m2 calculated with the CKD-EPI formula
Exclusion criteria
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 o Expected survival < 3 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is reduction in eGFR decline in patients treated with Envarsus® compared to Prograft® assessed by the absolute change in eGFR calculated by the 2012 CKD-EPI creatinine–cystatin C equation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary endpoints are: renal function measured by creatinine clearance in repeated 24h urine sample, percentage change in eGFR calculated by the 2012 CKD-EPI creatinine–cystatin C equation, incidence of new onset hypertension, incidence of new onset diabetes after transplantation (NODAT), CNI related neurotoxicity, transplant function, pharmacodynamic/pharmacokinec/pharacogenetic properties of LCP tacrolimus in lung transplant recipients. | — |
Contacts
Public ContactHeleen Grootjans
University Medical Center Groningen
Outcome results
None listed