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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
Must not have
Solitary pancreas transplant recipients
Currently maintained on an extended-release tacrolimus immunosuppressive regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
Select...
My pancreas transplant is working well without needing insulin or diabetes pills.
Select...
I am between 18 and 70 years old.
Select...
My kidney transplant is functioning well.
Select...
I understand the study and can give my consent.
Select...
I have Type 1 diabetes or insulin-dependent Type 2 diabetes with kidney disease.
Select...
I am a woman who can have children and I have a negative pregnancy test.
Select...
I am currently on Immediate-Release tacrolimus medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have received a pancreas transplant only.
Select...
I am currently on a long-acting tacrolimus medication plan.
Select...
I have had an organ transplant, but it was not a kidney or pancreas.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,040 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,231 Previous Clinical Trials
3,199,855 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
~4 spots leftby Dec 2025
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