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Immunosuppressant

Envarsus XR for Kidney Transplant (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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 2.5 months, 4.5 months, 5 months, 7 months, 9 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 Reported Distress

Change in Patient Reported Medication Adherence and Barriers

Change in Patient Reported Transplant Symptoms

+2 more

Secondary 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

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