Who is sponsoring NCT04917718?

NCT04917718 is sponsored by Loyola University.

What drugs are being tested in NCT04917718?

Interventions in NCT04917718: Conversion from IR Tacrolimus to XR Tacrolimus.

What condition does NCT04917718 study?

NCT04917718 studies Chronic Kidney Diseases, Heart Transplant.

Is NCT04917718 still recruiting?

NCT04917718 is currently status unknown. Last updated 13 April 2022.

Last reviewed 2022-04-13 · How we verify

NCT04917718

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From IR Tacrolimus to XR Tacrolimus

Status unknown Phase 4 Last updated 13 April 2022

What this trial tests

Phase 4 trial testing Conversion from IR Tacrolimus to XR Tacrolimus in Chronic Kidney Diseases in 42 participants. Status unknown.

Timeline

16 August 2021

Primary endpoint
31 December 2024

31 December 2024

Quick facts

Lead sponsor	Loyola University
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	42
Start date	16 August 2021
Primary completion	31 December 2024
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

Conversion from IR Tacrolimus to XR Tacrolimus — full drug profile →

Conditions studied

Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
Heart Transplant — all drugs for Heart Transplant →

Sponsor

Loyola University

Who can join

Adults 18 to 80, any sex, with Chronic Kidney Diseases or Heart Transplant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Lipocalin 2-not only a biomarker: a study of current literature and systematic findings of ongoing clinical trials.
Asaf S, Maqsood F, Jalil J, Sarfraz Z, et al · · 2023 · cited 38× · PMID 36529828 · DOI 10.1007/s12026-022-09352-2

Verify or expand the search:

Other recruiting trials for Chronic Kidney Diseases

Currently open trials in the same condition.

NCT06593392 — Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus · Phase 2 · recruiting
NCT07358572 — Eye-Brain-Kidney in CKD · recruiting
NCT06463483 — Automated Insulin Delivery in Adults With Advanced Kidney Disease · NA · recruiting
NCT06927024 — Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD) · NA · recruiting
NCT07115953 — Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension · NA · recruiting

Other Loyola University trials

Trials by the same sponsor.

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NCT07216664 — Multisensory Early Oral Administration of Human Milk (M-MILK) for Very Preterm Infants · NA · recruiting
NCT07226505 — Effects of Core Strengthening Exercises for Treating TMD · NA · not yet recruiting
NCT06525701 — Surgeon Core-strengthening Program as a Modifier for Exertion Associated With Vaginal Surgery · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04917718 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Loyola University
Last refreshed: 13 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04917718.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing