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NCT04917718UNKNOWNanonymous

Assessment of Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From Immediate Release Tacrolimus to Extended Release Tacrolimus.

Sponsor

Source record

Loyola University

Phase

Source record

PHASE4

Modality

AI-normalized

small molecule

Target

AI-normalized

Conversion from IR Tacrolimus to XR Tacrolimus

Indication / condition

AI-normalized

Chronic Kidney Diseases

Intervention

Source record

Conversion from IR Tacrolimus to XR Tacrolimus

Source & freshness

Source record

NCT ID

NCT04917718

Original source

ClinicalTrials.gov

Source last updated

Apr 13, 2022

Ingested at

Jun 08, 2026

Internal sync

Jun 08, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT04917718

Title

Assessment of Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From Immediate Release Tacrolimus to Extended Release Tacrolimus.

Sponsor

Loyola University

Status

UNKNOWN

Phase

PHASE4

Condition raw

Chronic Kidney Diseases, Heart Transplant

Condition normalized

Chronic Kidney Diseases, Heart Transplant

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Conversion from IR Tacrolimus to XR Tacrolimus

Target normalized

Conversion from IR Tacrolimus to XR Tacrolimus

Interventions

Conversion from IR Tacrolimus to XR Tacrolimus

Public preview

Source record

Immediate release (IR) tacrolimus peaks in the first two hours after administration. These peak levels are influenced by CYP3A5 expression with expressors requiring higher total daily doses with higher peak levels compared to non-expressors. Tacrolimus XR (Envarsus) is a once daily formulation with delayed absorption and lower peak levels while maintaining similar trough levels as seen with IR tacrolimus. A randomized trial of conversion from IR tacrolimus to tacrolimus XR in kidney transplant recipients have shown similar efficacy and adverse events between the two groups but no improvement in estimated GFR. However, urinary biomarkers of acute kidney injury associated with changes in tacrolimus dosing may be more sensitive then serum creatinine. The objective of this study is to assess renal tubular injury in heart transplant recipients who are converted from immediate release to tacrolimus XR. The hypothesis is that the delayed absorption and lower peak levels of tacrolimus XR will lead to less tubular injury and improved renal function without increased risk to the heart allograft.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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