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

Phase 3

Recruiting

• Conditions: lung transplant recipients; lung transplantation; 10012653; 10034606; 10029149

• Registration Number: NL-OMON53377
• Lead Sponsor: Academisch Medisch Centrum

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: 145

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

- Administration of mTOR inhibitors; everolimus, sirolimus
- Quadruple immunosuppression
- Also renal transplant recipient
Additional criteria for:
- Conversion study
o Expected survival < 3 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the absolute change in eGFR measured by cystatin C<br /><br>decline in patients treated with LCP tacrolimus compared to IR tacrolimus<br /><br>assessed by the absolute change in eGFR after 2 years. Cystatin C and<br /><br>creatinine will be used as a marker for eGFR. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are additional toxicity analyses including renal function<br /><br>measured with plasma creatinine, creatinine clearance in 24 hours urine<br /><br>analysis, incidence of hypertension, incidence of new onset diabetes after<br /><br>transplantation (NODAT), neurotoxicity, transplant function, quality of life<br /><br>and pharmacogenetic properties for LCP tacrolimus metabolism in the lung<br /><br>transplant population. </p><br>