2024-518639-12-00
Not yet recruiting
Phase 3
REVOLUTION; Randomized controlled trial comparing immediate versus extended release tacrolimus; reducing calcineurin inhibitor related toxicity in lung transplantation patients
Universitair Medisch Centrum Groningen1 site in 1 country140 target enrollmentStarted: January 28, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Kidney function
Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
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 and lung function o eGFR >30ml/min*1.73m2 calculated with the CKD-EPI formula
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Kidney function
Kidney function
Secondary Outcomes
No secondary outcomes reported
Investigators
C.T.Gan
Scientific
Universitair Medisch Centrum Groningen
Study Sites (1)
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