A Phase 4 interventional study of Envarsus XR and Tacrolimus in Delayed Graft Function, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Treatment
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.
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.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's enrollment of 100 is above the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.
Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Females of must have a negative urine or serum pregnancy test prior to randomization and agree to use adequate (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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of Care Tacrolimus
Drug: Tacrolimus
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.
Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.
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).
Time frame: up to 3 months post transplant
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.
Time frame: up to 3 months post transplant
Number of Participants Experiencing Related Adverse Events
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
Participants were recruited from the University of Wisconsin Hospital and Clinics between March 2019 and April 2022.
| Milestone | Standard of Care | Experimental |
|---|---|---|
| Started | 50 | 50 |
| Completed | 50 | 48 |
| Not completed | 0 | 2 |
| Withdrew: Death | 0 | 2 |
The primary endpoint of the study will be the length of time between first dialysis and last dialysis after kidney transplant (duration of DGF).
| days | Standard of Care | Experimental |
|---|---|---|
| Number of Days Needed to Recover From Delayed Graft Function (DGF) | 14.0 (7.5 to 21.0) | 15.0 (9.0 to 20.0) |
The secondary endpoint will be number of tacrolimus or Envarsus XR dose adjustments required during the period of DGF.
| dose adjustments | Standard of Care | Experimental |
|---|---|---|
| Number of Tacrolimus or Envarsus XR Dose Adjustments Required During the Period of DGF | 4.0 (3.0 to 6.0) | 3.0 (2.0 to 5.0) |
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.
| Participants | Standard of Care | Experimental |
|---|---|---|
| Number of Participants Experiencing Related Adverse Events | 50 | 48 |
Collected over up to 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/50 (0%) | 23/50 (46%) | 50/50 (100%) |
| Experimental | 2/50 (4%) | 26/50 (52%) | 50/50 (100%) |
| Event | Standard of Care | Experimental |
|---|---|---|
| fluid collection around kidney transplantSurgical and medical procedures | 6/50 | 5/50 |
| HematomaVascular disorders | 2/50 | 6/50 |
| Infections and Infestations - OtherInfections and infestations | 5/50 | 2/50 |
| OtherGastrointestinal disorders | 4/50 | 3/50 |
| OtherGeneral disorders | 0/50 | 4/50 |
| OtherRenal and urinary disorders | 2/50 | 4/50 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/50 | 4/50 |
| OtherRespiratory, thoracic and mediastinal disorders | 0/50 | 4/50 |
| Atrial FibrillationCardiac disorders | 3/50 | 1/50 |
| DiarrheaGastrointestinal disorders | 2/50 | 3/50 |
| Event | Standard of Care | Experimental |
|---|---|---|
| DiarrheaGastrointestinal disorders | 37/50 | 28/50 |
| Hand tremorNervous system disorders | 22/50 | 26/50 |
| NauseaGastrointestinal disorders | 14/50 | 18/50 |
| EdemaGeneral disorders | 10/50 | 13/50 |
| VomitingGastrointestinal disorders | 11/50 | 6/50 |
| HeadacheNervous system disorders | 9/50 | 11/50 |
| ConstipationGastrointestinal disorders | 5/50 | 9/50 |
| Acid RefluxGastrointestinal disorders | 9/50 | 2/50 |
| OtherInjury, poisoning and procedural complications | 1/50 | 9/50 |
| DizzinessNervous system disorders | 9/50 | 5/50 |
| Age, Customized(Participants) | Standard of Care | Experimental | Total |
|---|---|---|---|
| 30-39 years | 5 | 5 | 10 |
| 40-49 years | 8 | 11 | 19 |
| 50-59 years | 21 | 10 | 31 |
| 60-69 years | 12 | 17 | 29 |
| 70-79 years | 4 | 7 | 11 |
| Sex: Female, Male(Participants) | Standard of Care | Experimental | Total |
|---|---|---|---|
| Female | 19 | 12 | 31 |
| Male | 31 | 38 | 69 |
| Ethnicity (NIH/OMB)(Participants) | Standard of Care | Experimental | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 4 | 7 |
| Not Hispanic or Latino | 47 | 45 | 92 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Standard of Care | Experimental | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 4 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 15 | 30 |
| White | 29 | 32 | 61 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Standard of Care | Experimental | Total |
|---|---|---|---|
| United States | 50 | 50 | 100 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2019 to primary completion in Jul 2022, 40 months.
Results were first posted in Jun 2023, 10 months after primary completion.
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Studies of the drug tested here: Tacrolimus
University of Wisconsin, Madison →