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Immunosuppressant

Envarsus XR for Tremors Post-Transplant

Phase 2 & 3

Recruiting

Led By Jon S Odorico, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Stable pancreas allograft function as evidenced by no requirement of exogenous insulin or oral anti-diabetic agents and stable pancreatic enzymes

Adult, 18-70 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 6 months

Awards & highlights

Study Summary

This trial is testing a new treatment for tremors in kidney pancreas transplant recipients.

Who is the study for?

This trial is for adults aged 18-70 who had a simultaneous kidney and pancreas transplant between 3 months to 5 years ago, have stable organ function without diabetes medication, and developed tremors post-transplant. It's not for those with previous tremors, other organ transplants, specific immune system antibodies or on extended-release tacrolimus.Check my eligibility

What is being tested?

The study tests Envarsus XR in patients who received a simultaneous pancreas-kidney transplant. It aims to see if this drug can manage tremors that started after the surgery. Participants must currently be taking Immediate-Release tacrolimus and will switch to Envarsus XR.See study design

What are the potential side effects?

Envarsus XR may cause similar side effects as other immunosuppressants like increased infection risk, possible kidney damage, high blood pressure, shaking (tremor), headache, gastrointestinal issues such as nausea or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pancreas transplant is working well without needing insulin or diabetes pills.

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I am between 18 and 70 years old.

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My kidney transplant is functioning well.

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I understand the study and can give my consent.

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I have Type 1 diabetes or insulin-dependent Type 2 diabetes with kidney disease.

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I am a woman who can have children and I have a negative pregnancy test.

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I am currently on Immediate-Release tacrolimus medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~over 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and over 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in patient and physician-assessed degree of tremors based on Fahn-Tolosa-Marin Tremor Rating Scale

Change in patient and physician-assessed degree of tremors based on Quality of Life in Essential Tremor (QUEST) Questionnaire

Scores on Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) Questionnaire

+1 more

Secondary outcome measures

Comparable or improved glycemic control as measured by HbA1c

Comparable or improved glycemic control as measured by mixed meal tolerance test

Mycophenolate doses and levels

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Envarsus XRExperimental Treatment1 Intervention

Envarsus XR (extended release) will be administered orally, once-daily, for 6 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Envarsus XR

2017

Completed Phase 4

~230

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Veloxis PharmaceuticalsIndustry Sponsor

41 Previous Clinical Trials

3,116 Total Patients Enrolled

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,516 Total Patients Enrolled

Jon S Odorico, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

Envarsus XR (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT03769298 — Phase 2 & 3

Kidney Pancreas Transplant Research Study Groups: Envarsus XR

Kidney Pancreas Transplant Clinical Trial 2023: Envarsus XR Highlights & Side Effects. Trial Name: NCT03769298 — Phase 2 & 3

Envarsus XR (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03769298 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

Envarsus XR is typically given to patients for what reason?

"Envarsus XR can help patients manage dermatitis, atopic conditions, and organ transplant rejection."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

Transplantation ProceedingsJournal

Meltdose Tacrolimus Pharmacokinetics

Baraldo, M.. 2016. “Meltdose Tacrolimus Pharmacokinetics”. Transplantation Proceedings. Elsevier BV. doi:10.1016/j.transproceed.2016.02.002.

Movement DisordersJournal

Assessment of Interrater and Intrarater Reliability of the Fahn-tolosa-marin Tremor Rating Scale in Essential Tremor

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.

Cardiovascular DiabetologyJournal

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

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.

Indian Journal of Endocrinology and MetabolismJournal