Envarsus XR for Kidney Pancreas Transplant

University of Wisconsin, Madison, WI
Kidney Pancreas TransplantEnvarsus XR - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study Summary

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

Treatment Effectiveness

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: Over 6 months

Over 6 months
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
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
Renal function by eGFR (estimated Glomerular Filtration Rate)
Renal function by serum creatinine
Scores on Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) Questionnaire
Scores on Quality of Life in Essential Tremor Questionnaires
Tacrolimus doses and levels

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

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

Envarsus XR
Drug
Experimental Group · 1 Intervention: Envarsus XR · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: over 6 months

Who is running the clinical trial?

Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,120 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,101 Previous Clinical Trials
2,900,273 Total Patients Enrolled
Jon S Odorico, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Eligibility Criteria

Age 18 - 70 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have experienced shaking (tremors) after receiving an organ transplant in the past.
References

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.