Envarsus in Delayed Graft Function (E-DGF)

NCT ID: NCT03864926

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-18
• Study Completion Date: 2022-07-22

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.

Conditions

Delayed Graft Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Standard of Care Tacrolimus

Group Type: ACTIVE_COMPARATOR

Tacrolimus

Intervention Type: DRUG

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

Experimental

Envarsus XR

Group Type: EXPERIMENTAL

Envarsus XR

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Tacrolimus

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veloxis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandesh Parajuli, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin School of Medicine and Public Health, Madison

Locations

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

References

Parajuli S, Bloom M, Mandelbrot D, Astor BC. Serum beta2-Microglobulin Predicts Time to Recovery of Delayed Graft Function in Kidney Transplant Recipients. Clin Transplant. 2024 Aug;38(8):e15435. doi: 10.1111/ctr.15435.

Reference Type: DERIVED

PMID: 39158946 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A534280

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/NEPHROLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0530

Identifier Type: -

Identifier Source: org_study_id