Envarsus in Delayed Graft Function (E-DGF) (E-DGF)
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|ClinicalTrials.gov Identifier: NCT03864926|
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : July 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Delayed Graft Function||Drug: Envarsus XR Drug: Tacrolimus||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Envarsus in Delayed Graft Function: A Phase IV, Randomized, Single Center Study Among Kidney Transplant Recipients With Delayed Graft Function (DGF) to Study the Effect of Envarsus XR in the DGF Recovery|
|Actual Study Start Date :||March 18, 2019|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||August 2021|
Active Comparator: Standard of Care
Standard of Care Tacrolimus
Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.
Drug: Envarsus XR
Envarsus XR is FDA approved for the prophylaxis of organ rejection in kidney transplant recipients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Envarsus XR, is designed to deliver tacrolimus more smoothly over the whole day.
Envarsus XR, a calcineurin-inhibitor immunosuppressant, is available for oral administration as extended-release tablets containing the equivalent of 0.75 mg, 1 mg, or 4 mg of anhydrous tacrolimus USP. Inactive ingredients include hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF. Tacrolimus is the active ingredient in ENVARSUS XR.
- Number of days needed to recover from delayed graft function (DGF) [ Time Frame: up to 3 months post transplant ]The primary endpoint of the study will be the length of time between first dialysis and last dialysis after kidney transplant (duration of DGF).
- Number of Tacrolimus or Envarsus XR Dose Adjustments Required During the Period of DGF. [ Time Frame: up to 3 months post transplant ]The secondary endpoint will be number of tacrolimus or Envarsus XR dose adjustments required during the period of DGF.
- Number of participants experiencing related adverse events [ Time Frame: up to 3 months post transplant ]Number of participants having adverse event will be reported. Adverse events includes the events such as: infections, malignancies, hematological complications including leukopenia, anemia, and thrombocytopenia, cardiovascular complications and events, neuropathy, tremors, gastrointestinal symptoms, uncontrolled hypertension, serious electrolytes abnormalities and immunosuppression-related adverse effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864926
|Contact: Meghan Talukdar, BSfirstname.lastname@example.org|
|Contact: Lucille Ptak, BSemail@example.com|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Meghan K Talukdar, BS|
|Principal Investigator:||Sandesh Paranjuli, MBBS||University of Wisconsin School of Medicine and Public Health, Madison|