Study Summary
This trial is testing whether a once-daily tacrolimus pill leads to less kidney damage and better function than the current tacrolimus pill taken multiple times a day.
- Heart Transplant
- Chronic Kidney Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: 1 year
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Extended Release Tacrolimus
1 of 1
Experimental Treatment
42 Total Participants · 1 Treatment Group
Primary Treatment: Conversion from IR Tacrolimus to XR Tacrolimus · No Placebo Group · Phase 4
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 80 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Trofe-Clark, Jennifer, Daniel C. Brennan, Patricia West-Thielke, Michael C. Milone, Mary Ann Lim, Robin Neubauer, Vincenza Nigro, and Roy D. Bloom. 2018. “Results of ASERTAA, a Randomized Prospective Crossover Pharmacogenetic Study of Immediate-release Versus Extended-release Tacrolimus in African American Kidney Transplant Recipients”. American Journal of Kidney Diseases. Elsevier BV. doi:10.1053/j.ajkd.2017.07.018.
- Myers, Bryan D., Jon Ross, Lynn Newton, John Luetscher, and Mark Perlroth. 1984. “Cyclosporine-associated Chronic Nephropathy”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm198409133111103.
- Vaidya, Vishal S, Josef S Ozer, Frank Dieterle, Fitz B Collings, Victoria Ramirez, Sean Troth, Nagaraja Muniappa, et al.. 2010. “Kidney Injury Molecule-1 Outperforms Traditional Biomarkers of Kidney Injury in Preclinical Biomarker Qualification Studies”. Nature Biotechnology. Springer Science and Business Media LLC. doi:10.1038/nbt.1623.
- Câmara, Niels Olsen Saraiva, Ana Cristina Carvalho Matos, Dirceu Almeida Rodrigues, Aparecido Bernardo Pereira, and Alvaro Pacheco-Silva. 2001. “Early Detection of Heart Transplant Patients with Increased Risk of Ciclosporin Nephrotoxicity”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(00)04207-0.
- Cosio, Fernando G., Hatem Amer, Joseph P. Grande, Timothy S. Larson, Mark D. Stegall, and Matthew D. Griffin. 2007. “Comparison of Low Versus High Tacrolimus Levels in Kidney Transplantation: Assessment of Efficacy by Protocol Biopsies”. Transplantation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.tp.0000251807.72246.7d.
- Bunnapradist, S., K. Ciechanowski, P. West‐Thielke, S. Mulgaonkar, L. Rostaing, B. Vasudev, K. Budde, and on behalf of the MELT investigators. 2012. “Conversion from Twice‐daily Tacrolimus to Once‐daily Extended Release Tacrolimus (LCPT): The Phase III Randomized MELT Trial”. American Journal of Transplantation. Wiley. doi:10.1111/ajt.12035.
- Naesens, Maarten, Dirk R. J. Kuypers, and Minnie Sarwal. 2009. “Calcineurin Inhibitor Nephrotoxicity”. Clinical Journal of the American Society of Nephrology. American Society of Nephrology (ASN). doi:10.2215/cjn.04800908.
- Chancharoenthana, Wiwat, Asada Leelahavanichkul, Salin Wattanatorn, Yingyos Avihingsanon, Kearkiat Praditpornsilpa, Somchai Eiam-Ong, and Natavudh Townamchai. 2018. “Alteration of Urinary Neutrophil Gelatinase–associated Lipocalin as a Predictor of Tacrolimus-induced Chronic Renal Allograft Fibrosis in Tacrolimus Dose Adjustments Following Kidney Transplantation”. Edited by Stanislaw Stepkowski. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0209708.
- Tsuchimoto, Ayami, Haruka Shinke, Miwa Uesugi, Mio Kikuchi, Emina Hashimoto, Tomoko Sato, Yasuhiro Ogura, et al.. 2014. “Urinary Neutrophil Gelatinase-associated Lipocalin: A Useful Biomarker for Tacrolimus-induced Acute Kidney Injury in Liver Transplant Patients”. Edited by Martin H. de Borst. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0110527.
- Ojo, Akinlolu O., Philip J. Held, Friedrich K. Port, Robert A. Wolfe, Alan B. Leichtman, Eric W. Young, Julie Arndorfer, Laura Christensen, and Robert M. Merion. 2003. “Chronic Renal Failure After Transplantation of a Nonrenal Organ”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa021744.
- Trofe-Clark, Jennifer, Daniel C. Brennan, Patricia West-Thielke, Michael C. Milone, Mary Ann Lim, Robin Neubauer, Vincenza Nigro, and Roy D. Bloom. 2018. “Results of ASERTAA, a Randomized Prospective Crossover Pharmacogenetic Study of Immediate-release Versus Extended-release Tacrolimus in African American Kidney Transplant Recipients”. American Journal of Kidney Diseases. Elsevier BV. doi:10.1053/j.ajkd.2017.07.018.
- Naesens M, Kuypers DR, Sarwal M. Calcineurin inhibitor nephrotoxicity. Clin J Am Soc Nephrol. 2009 Feb;4(2):481-508. doi: 10.2215/CJN.04800908.
- Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, Arndorfer J, Christensen L, Merion RM. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003 Sep 4;349(10):931-40. doi: 10.1056/NEJMoa021744.
- Myers BD, Ross J, Newton L, Luetscher J, Perlroth M. Cyclosporine-associated chronic nephropathy. N Engl J Med. 1984 Sep 13;311(11):699-705. doi: 10.1056/NEJM198409133111103.
- Chancharoenthana W, Leelahavanichkul A, Wattanatorn S, Avihingsanon Y, Praditpornsilpa K, Eiam-Ong S, Townamchai N. Alteration of urinary neutrophil gelatinase-associated lipocalin as a predictor of tacrolimus-induced chronic renal allograft fibrosis in tacrolimus dose adjustments following kidney transplantation. PLoS One. 2018 Dec 21;13(12):e0209708. doi: 10.1371/journal.pone.0209708. eCollection 2018. Erratum In: PLoS One. 2019 Feb 22;14(2):e0213009.
- Camara NO, Matos AC, Rodrigues DA, Pereira AB, Pacheco-Silva A. Early detection of heart transplant patients with increased risk of ciclosporin nephrotoxicity. Lancet. 2001 Mar 17;357(9259):856-7. doi: 10.1016/S0140-6736(00)04207-0.
- Cosio FG, Amer H, Grande JP, Larson TS, Stegall MD, Griffin MD. Comparison of low versus high tacrolimus levels in kidney transplantation: assessment of efficacy by protocol biopsies. Transplantation. 2007 Feb 27;83(4):411-6. doi: 10.1097/01.tp.0000251807.72246.7d.
- Sanjeev Akkina 2021. "Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From IR Tacrolimus to XR Tacrolimus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04917718.
Frequently Asked Questions
What is the total number of participants recruited for this experiment?
"Affirmative. According to the available data on clinicaltrials.gov, this study is actively seeking participants; it first opened for enrollment on August 16th 2021 and was recently updated April 12th 2022. 42 people are required from a single site." - Anonymous Online Contributor
What medical conditions are often addressed by transitioning from IR Tacrolimus to XR Tacrolimus?
"Conversion from IR Tacrolimus to XR Tacrolimus is a frequently prescribed treatment for atopic dermatitis. Research has also established that this medication can be an effective remedy against liver and kidney transplant rejection, psoriasis, as well as other conditions." - Anonymous Online Contributor
Could I potentially participate in this investigation?
"The criteria for enrollment in this clinical trial is quite specific: patients must be afflicted with a form of kidney disease and aged between 18 - 80. The maximum number of participants being sought out amounts to 42 individuals." - Anonymous Online Contributor
Does this research offer inclusion to individuals below the age of seventy-five?
"To be eligible for this medical research, individuals must be of legal age and under 80 years old. Participants younger than 18 are required to join 88 other trials while those over 65 can sign up for 582 studies." - Anonymous Online Contributor
Is a shift from immediate-release to extended-release tacrolimus generally secure for patients?
"With the medication already approved, our team has assigned a score of 3 to Conversion from IR Tacrolimus to XR Tacrolimus in terms of safety." - Anonymous Online Contributor
Are any participants being enrolled in this research protocol at present?
"As indicated by the data on clinicaltrials.gov, this study is currently enlisting volunteers for participation. This trial was initially published on August 16th 2021 and has been revised most recently on April 12th 2022." - Anonymous Online Contributor
Are there any records of transitioning from immediate release to extended release tacrolimus?
"Currently, 150 clinical trials are in progress to assess the efficacy of Conversion from IR Tacrolimus to XR Tacrolimus. Of those studies, 18 have progressed into phase 3 and 871 locations around the world are running these investigations. Nashville, Tennessee is host to a majority of these medical experiments." - Anonymous Online Contributor