‘Randomized controlled prospEctiVe trial comparing extended-release with immediate-release tacrOlimus; reducing calcineurin inhibitor related toxicity in LUng TransplantatION patients’

Recruiting

• Conditions: lung transplantation

• Registration Number: NL-OMON29263
• Lead Sponsor: niversity Medical Center Groningen (UMCG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 150

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br>