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NCT Number: NCT03864926

Envarsus in Delayed Graft Function (E-DGF)

Envarsus XR is an extended release tacrolimus designed to deliver tacrolimus more consistently, thus avoiding large fluctuations of tacrolimus trough levels with Envarsus XR compared to immediate release tacrolimus. It is expected that patients with DGF on Envarsus XR will have more stable tacrolimus levels and facilitate early recover from DGF compared to immediate release tacrolimus.

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Key information

Conditions

Delayed Graft Function Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

About this study

This is a single center randomized phase IV trial of comparing extended release Envarsus XR (study drug) once a day vs immediate release tacrolimus twice a day in a new kidney transplant recipients with delayed graft function (DGF). The primary study endpoint is the interval between first dialysis and last dialysis after kidney transplant (duration of DGF). The second end point is the number of tacrolimus or Envarsus XR dose adjustments required during the period of DGF.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing and able to provide written informed consent
  • Willing to comply with all study procedures and be available for the duration of the study
  • Male or female, at least 18 years of age
  • Documented diagnosis of DGF or need for dialysis or had dialysis within the first week of kidney transplant
  • Current treatment with tacrolimus based regimen or planned to start tacrolimus based immunosuppressive regimen
  • Females of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy.
  • A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Exclusion criteria

  • History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes
  • Current use of non-tacrolimus based immunosuppressive regimen or no plan to start tacrolimus based regimen
  • Women who are or plan to become pregnant or breast-feeding during the study period
  • Not suitable for study participation due to other reasons at the discretion of the investigator
  • Major post-surgical complications requiring allograft nephrectomy
  • Multi-organ transplant recipients
  • Non kidney transplant recipients

Treatment and study plan

Envarsus XR

Drug

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.

Tacrolimus

Drug

Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Veloxis Pharmaceuticals

Registry information

Official study 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

Acronym: E-DGF

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2019
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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