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

Primary Purpose

Delayed Graft Function

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Envarsus XR

Tacrolimus

About this trial

This is an interventional treatment trial for Delayed Graft Function focused on measuring Kidney Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Wisconsin Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Experimental

Arm Description

Standard of Care Tacrolimus

Envarsus XR

Outcomes

Primary Outcome Measures

Number of Days Needed to Recover From Delayed Graft Function (DGF)

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

Number of Tacrolimus or Envarsus XR Dose Adjustments Required During the Period of DGF

The secondary endpoint will be number of tacrolimus or Envarsus XR dose adjustments required during the period of DGF.

Full Information

NCT ID

NCT03864926

First Posted

March 5, 2019

Last Updated

July 12, 2023

Sponsor

University of Wisconsin, Madison

Collaborators

Veloxis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03864926

Brief Title

Envarsus in Delayed Graft Function (E-DGF)

Acronym

E-DGF

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

March 18, 2019 (Actual)

Primary Completion Date

July 22, 2022 (Actual)

Study Completion Date

July 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

Veloxis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Delayed Graft Function

Keywords

Kidney Transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

Standard of Care Tacrolimus

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Envarsus XR

Intervention Type

Drug

Intervention Name(s)

Envarsus XR

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Tacrolimus

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Days Needed to Recover From Delayed Graft Function (DGF)

Description

The primary endpoint of the study will be the length of time between first dialysis and last dialysis after kidney transplant (duration of DGF).

Time Frame

up to 3 months post transplant

Secondary Outcome Measure Information:

Title

Number of Tacrolimus or Envarsus XR Dose Adjustments Required During the Period of DGF

Description

The secondary endpoint will be number of tacrolimus or Envarsus XR dose adjustments required during the period of DGF.

Time Frame

up to 3 months post transplant

Other Pre-specified Outcome Measures:

Title

Number of Participants Experiencing Related Adverse Events

Description

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.

Time Frame

up to 3 months post transplant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandesh Parajuli, MBBS

Organizational Affiliation

University of Wisconsin School of Medicine and Public Health, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin Hospital and Clinics

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Envarsus in Delayed Graft Function (E-DGF)

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