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Envarsus in Delayed Graft Function (E-DGF) (E-DGF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03864926
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
Veloxis Pharmaceuticals
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Delayed Graft Function Drug: Envarsus XR Drug: Tacrolimus Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Active Comparator: Standard of Care
Standard of Care Tacrolimus
Drug: Tacrolimus
Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.

Experimental: Experimental
Envarsus XR
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.





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to provide written informed consent
  2. Willing to comply with all study procedures and be available for the duration of the study
  3. Male or female, at least 18 years of age
  4. Documented diagnosis of DGF or need for dialysis or had dialysis within the first week of kidney transplant
  5. Current treatment with tacrolimus based regimen or planned to start tacrolimus based immunosuppressive regimen
  6. 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:

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

Information from the National Library of Medicine

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


Contacts
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Contact: Meghan Talukdar, BS 608-263-1864 mkcrain@medicine.wisc.edu
Contact: Lucille Ptak, BS 608-262-0731 ldptak@medicine.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Meghan K Talukdar, BS         
Sponsors and Collaborators
University of Wisconsin, Madison
Veloxis Pharmaceuticals
Investigators
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Principal Investigator: Sandesh Paranjuli, MBBS University of Wisconsin School of Medicine and Public Health, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03864926    
Other Study ID Numbers: 2018-0530
A534280 ( Other Identifier: UW Madison )
SMPH/MEDICINE/NEPHROLOGY ( Other Identifier: UW Madison )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Wisconsin, Madison:
Kidney Transplant
Additional relevant MeSH terms:
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Delayed Graft Function
Pathologic Processes
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action