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Randomized controlled trial comparing immediate versus extended release tacrolimus; reducing calcineurin inhibitor related toxicity in lung transplantation patients
EU CTIS ID: 2024-518639-12-00
What this study is testing
To compare absolute difference in renal function expressed as absolute difference in eGFR, at 2 years compared to baseline, calculated by the 2012 CKD-EPI creatinine–cystatin C equation in patients treated with IR or LCP tacrolimus.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 and lung function o eGFR >30ml/min*1.73m2 calculated with the CKD-EPI formula
You likely can't join if
- Administration of mTOR inhibitors; everolimus, sirolimus - Quadruple immunosuppression - Renal transplantation - The subject has any disease or condition that might interfere with completion of this study or reaching the primary endpoint (e.g., life expectancy of <3 years, renal replacement therapy at start study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.