Delayed Graft FunctionPhase 4E-DGFNCT03864926
Envarsus in Delayed Graft Function (E-DGF)
A Phase 4 study testing Envarsus XR and Tacrolimus in people with Delayed Graft Function, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function
- What is being tested?
- Envarsus XR and Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2019to 22 Jul 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
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
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.
Read the 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
- Being tested
- Envarsus XR, Tacrolimus
- Keywords
- Kidney Transplant
- Medical subject headings
- Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Envarsus XRDrug
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.
TacrolimusDrug
Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Standard of Care Tacrolimus Receives: Drug: Tacrolimus |
| Experimental | Experimental | Envarsus XR Receives: Drug: Envarsus XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 3 months post transplant
Secondary outcomes (1)
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.
Measured: up to 3 months post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start18 Mar 2019
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Sandesh Parajuli, MBBS, Principal investigator, University of Wisconsin School of Medicine and Public Health, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864926
- Sponsor's protocol ID
- 2018-0530
- Other IDs
- A534280, SMPH/MEDICINE/NEPHROLOGY
- Acronym
- E-DGF
- Status last verified
- May 2023
- First submitted
- 5 Mar 2019
- Last updated
- 20 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 39158946
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03864926
- Acronym / sponsor ID
- E-DGF / 2018-0530
- Conditions
- Delayed Graft Function
- Keywords
- Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Posted 5 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: TacrolimusStandard of Care Tacrolimus |
| Experimental | Experimental | Drug: Envarsus XREnvarsus XR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Envarsus XREnvarsus 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. | Drug | Experimental |
| TacrolimusTacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients. | Drug | Standard of Care |
Primary outcome
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).
1 secondary outcome
Number of Tacrolimus or Envarsus XR Dose Adjustments Required During the Period of DGF
Time frame: up to 3 months post transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39158946Parajuli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandesh Parajuli, MBBS principal investigator
University of Wisconsin School of Medicine and Public Health, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Envarsus XR and Tacrolimus in people with Delayed Graft Function, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days Needed to Recover From Delayed Graft Function (DGF) (time frame: up to 3 months post transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.