An observational study in Disorder Related to Renal Transplantation, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2020-04-22.
Sponsored by University of Illinois at Chicago · Observational
This study will investigate whether converting patients from FDA approved immediate-release tacrolimus to FDA approved extended release tacrolimus (Envarsus) reduces neurological side-effects, improves quality of life, and enhances adherence. A select group of elderly (> 60 years of age) patients, who are especially sensitive to tacrolimus-related adverse (AEs) effects, will be provided the opportunity to convert to Envarsus with this study.
Tacrolimus (Prograf) is a calcineurin inhibitor that is widely used in all types of solid organ transplants. However, one of the major limitations in using tacrolimus are the adverse effects that significantly reduce a transplant recipient's quality-of-life (QOL). These QOL reducing AEs associated with tacrolimus include post-transplant diabetes mellitus, neurotoxicity, diarrhea, nephrotoxicity, and alopecia. A recent open-label, multicenter, prospective phase 3b study showed that Envarsus significantly reduced tremors and improved quality of life when compared to tacrolimus. It is postulated that the mechanism behind tremor reduction occurs as a result of lower Cmax tacrolimus concentrations with the new Envarsus formulation. Given its ability for tremor improvement, it would be beneficial to investigate whether conversion from tacrolimus to Envarsus can improve other neurological AEs such as insomnia vertigo, photophobia, mood disturbances, or headache. In particular, the elderly are especially sensitive to tacrolimus-related AEs and may benefit from tacrolimus to Envarsus conversion. Further, it is useful to understand the cost effectiveness of converting to Envarsus in this patient population.
Study duration: 35 days per subject until a total of 40 subjects are enrolled. Patients will have a total of 4 visits.
This study will enroll elderly kidney transplant recipients who are at least 60 years of age and have experienced neurological adverse events while on generic tacrolimus, Prograf, or Astagraf XL.
Exclusion Criteria:
Drug: Tacrolimus XR (Envarsus)
Elderly patients (age 60 or older) on tacrolimus experiencing neurological AEs (tremor, insomnia, vertigo, photophobia, mood disturbances, or headache) presumably from tacrolimus immediate-release or tacrolimus XL will be converted to Envarsus. This conversion will be based on the Envarsus package insert which is a 20% reduction in total daily dose and is taken once a day. The conversion from Astagraf to Envarsus will be a 36% reduction.
Quality of life (QOL)
Mean change in QOL scores from baseline to day 14 and day 28 after conversion from tacrolimus to Envarsus.
Time frame: through study completion, an average of two years
Neurological Scores
Mean change in neurological scores (including insomnia, vertigo, photophobia, mood, headache, and tremor) from baseline to day 14 and day 28 after conversion from tacrolimus to Envarsus.
Time frame: through study completion, an average of two years
Tacrolimus preference
Proportion of patients preferring Envarsus compared with their previous tacrolimus formulation after 28 days of treatment
Time frame: through study completion, an average of two years
Non-adherence
Percent of patients reporting non-adherence from baseline to day 14 and 28 after conversion from tacrolimus to Envarsus.
Time frame: through study completion, an average of two years
Incremental costs
Mean incremental costs from baseline to day 28 following conversion to Envarsus.
Time frame: through study completion, an average of two years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Illinois at Chicago