Study Summary
This trial is testing a new treatment for tremors in kidney pancreas transplant recipients.
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
4 Primary · 6 Secondary · Reporting Duration: Over 6 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
1 Treatment Group
Envarsus XR
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Envarsus XR · No Placebo Group · Phase 2 & 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 70 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Baraldo, M.. 2016. “Meltdose Tacrolimus Pharmacokinetics”. Transplantation Proceedings. Elsevier BV. doi:10.1016/j.transproceed.2016.02.002.
- Stacy, Mark A., Rodger J. Elble, William G. Ondo, Shu-Chen Wu, Joseph Hulihan, and TRS Study Group. 2007. “Assessment of Interrater and Intrarater Reliability of the Fahn-tolosa-marin Tremor Rating Scale in Essential Tremor”. Movement Disorders. Wiley. doi:10.1002/mds.21412.
- Ohkura, Tsuyoshi, Hideki Shiochi, Youhei Fujioka, Keisuke Sumi, Naoya Yamamoto, Kazuhiko Matsuzawa, Shoichiro Izawa, et al.. 2013. “20/(fasting C-peptide × Fasting Plasma Glucose) Is a Simple and Effective Index of Insulin Resistance in Patients with Type 2 Diabetes Mellitus: A Preliminary Report”. Cardiovascular Diabetology. Springer Science and Business Media LLC. doi:10.1186/1475-2840-12-21.
- Gutch, Manish, Sukriti Kumar, SyedMohd Razi, KumarKeshav Gupta, and Abhinav Gupta. 2015. “Assessment of Insulin Sensitivity/resistance”. Indian Journal of Endocrinology and Metabolism. Medknow. doi:10.4103/2230-8210.146874.
- Langone, Anthony, Steven M. Steinberg, Roberto Gedaly, Laurence K. Chan, Tariq Shah, Kapil D. Sethi, Vincenza Nigro, et al.. 2015. “Switching st Udy of Kidney Transplant pa Tients with Tremor to lcp ‐tacro ( strato ): An Open‐label, Multicenter, Prospective Phase 3b Study”. Clinical Transplantation. Wiley. doi:10.1111/ctr.12581.
- Kerstenetzky, L., J. L. Descourouez, M. R. Jorgenson, D. C. Felix, D. A. Mandelbrot, R. R. Redfield, and J. S. Odorico. 2017. “A Single-center Experience with Tacrolimus LCP (envarsus XR) in Pancreas Transplant Recipients”. Annals of Pharmacotherapy. SAGE Publications. doi:10.1177/1060028017749076.
- Forbes, S., R. A. Oram, A. Smith, A. Lam, T. Olateju, S. Imes, A. J. Malcolm, A. M. J. Shapiro, and P. A. Senior. 2016. “Validation of the beta ‐2 Score: An Improved Tool to Estimate Beta Cell Function After Clinical Islet Transplantation Using a Single Fasting Blood Sample”. American Journal of Transplantation. Wiley. doi:10.1111/ajt.13807.
- Langone, Anthony, Steven M. Steinberg, Roberto Gedaly, Laurence K. Chan, Tariq Shah, Kapil D. Sethi, Vincenza Nigro, et al.. 2015. “Switching st Udy of Kidney Transplant pa Tients with Tremor to lcp ‐tacro ( strato ): An Open‐label, Multicenter, Prospective Phase 3b Study”. Clinical Transplantation. Wiley. doi:10.1111/ctr.12581.
- Kerstenetzky L, Descourouez JL, Jorgenson MR, Felix DC, Mandelbrot DA, Redfield RR, Odorico JS. A Single-Center Experience With Tacrolimus LCP (Envarsus XR) in Pancreas Transplant Recipients. Ann Pharmacother. 2018 Apr;52(4):392-396. doi: 10.1177/1060028017749076. Epub 2017 Dec 14. No abstract available.
- Stacy MA, Elble RJ, Ondo WG, Wu SC, Hulihan J; TRS study group. Assessment of interrater and intrarater reliability of the Fahn-Tolosa-Marin Tremor Rating Scale in essential tremor. Mov Disord. 2007 Apr 30;22(6):833-8. doi: 10.1002/mds.21412.
- Ohkura T, Shiochi H, Fujioka Y, Sumi K, Yamamoto N, Matsuzawa K, Izawa S, Kinoshita H, Ohkura H, Kato M, Taniguchi S, Yamamoto K. 20/(fasting C-peptide x fasting plasma glucose) is a simple and effective index of insulin resistance in patients with type 2 diabetes mellitus: a preliminary report. Cardiovasc Diabetol. 2013 Jan 22;12:21. doi: 10.1186/1475-2840-12-21.
- 2019. "CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03769298.
Frequently Asked Questions
Are any elderly patients a part of this research?
"The eligibility requirements for this study are that participants must be between 18-70 years old. There are 44 other trials available for people who do not meet this age criteria and 120 trials for those older than 65." - Anonymous Online Contributor
Envarsus XR is typically given to patients for what reason?
"Envarsus XR can help patients manage dermatitis, atopic conditions, and organ transplant rejection." - Anonymous Online Contributor
How many patients are enrolled in this research project?
"The clinicaltrials.gov website indicates that this trial is still looking for volunteers. This research project was initially announced on February 27th, 2019 and the most recent update was on April 5th, 2022. So far, only one facility has been used but the team needs 30 more participants." - Anonymous Online Contributor
What goal does this experiment aim to achieve?
"The purpose of this trial, which will last for 6 months, is to collect data on patients' Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) Questionnaire scores. Other important metrics that will be tracked include glycemic control, renal function, and mycophenolate doses and levels." - Anonymous Online Contributor
Are patients still being enrolled in this clinical trial?
"Yes, this study detailed on clinicaltrials.gov is currently seeking participants. The trial was originally listed on February 27th, 2019 and has had its information updated as recently as April 5th, 2022." - Anonymous Online Contributor
Who meets the selection criteria for this clinical trial?
"Patients that meet the requirements of being 18 to 70 years old and having stage 3 or 4 kidney disease are encouraged to apply for this study. The ideal number of participants is 30." - Anonymous Online Contributor
Are there any other ongoing or completed research projects that have utilized Envarsus XR?
"Envarsus XR is being investigated in 153 different active clinical trials, 18 of which are in Phase 3. The vast majority of these studies are based in the city of Philadelphia within the state of Pennsylvania; however, there are 875 locations worldwide where research into Envarsus XR is conducted." - Anonymous Online Contributor