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Immunosuppressant
Envarsus XR® in Adolescent Renal Transplant Recipients (EnvarsusXR Trial)
Phase 4
Waitlist Available
Led By Rachana Srivastava, MD
Research Sponsored by Meghan Pearl, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 2.5 months, 4.5 months, 5 months, 7 months, 9 months
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial is testing a new version of tacrolimus called Envarsus XR® in adolescent organ transplant recipients. The goal is to see if taking the medication helps these patients stick to their treatment better and experience fewer side effects. Tacrolimus is used in organ transplantation, originally formulated as Prograf®, which needed to be taken more frequently. Newer versions like Envarsus® XR have been developed to improve patient adherence.
Eligible Conditions
- Kidney Transplant
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks, 2.5 months, 4.5 months, 5 months, 7 months, 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks, 2.5 months, 4.5 months, 5 months, 7 months, 9 months
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 Reported Distress
Change in Patient Reported Medication Adherence and Barriers
Change in Patient Reported Transplant Symptoms
+2 moreSecondary study objectives
Incidence of IgG3 and C1q positive Donor Specific Antibodies
Tacrolimus Dose Exposure
Tacrolimus Trough Coefficient of Variation
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B-Envarsus then TacrolimusExperimental Treatment2 Interventions
Envarsus XR® 14 day run-in followed by 4 months of follow-up and then crossing over to immediate release tacrolimus (twice a day oral formulation) with a 14 day run-in followed by 4 months of follow-up.
Group II: Arm A-Tacrolimus then EnvarsusExperimental Treatment2 Interventions
Immediate release tacrolimus (twice a day oral formulation) 14 day run-in followed by 4 months of follow-up and then crossing over to Envarsus XR® with a 14 day run-in followed by 4 months of follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
FDA approved
Tacrolimus
FDA approved
Find a Location
Who is running the clinical trial?
Meghan Pearl, MDLead Sponsor
University of California, Los AngelesLead Sponsor
1,569 Previous Clinical Trials
10,314,261 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,042 Total Patients Enrolled
Rachana Srivastava, MDPrincipal InvestigatorUniversity of California, Los Angeles