End Stage Renal DiseasePhase 2/3NCT03321656
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
A Phase 2/3 study testing Tacrolimus and Envarsus XR in people with End Stage Renal Disease, run by Roberto Gedaly at 1 site in United States.
Trial summary
This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Tacrolimus and Envarsus XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2019to 31 Mar 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent in English able to understand and provide informed consent.
- End stage renal disease listed for primary solitary kidney transplant.
- Willing to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent.
- Female who are of childbearing potential will be asked to use 2 different medically acceptable methods of contraception for the duration of the study and at least 1 year post-infusion.
Who cannot join
- Previously undergone organ, tissue or cell transplant
- Allergic to Tacrolimus or MMF (Cellcept)
- Chronic use of blood thinners
- Previous chronic use of glucocorticoids or other immunosuppression, or biologic immunomodulators (prescribed for the treatment of serious inflammatory disorders)
- Significant or active infection
- Diagnosed with HIV, Hepatitis B or C, Herpes simplex virus, Varicella-Zoster virus, Epstein-Barr virus
Show all 14Show fewer
- Have or have had cancer with in the past 3 years
- Have taken part in another study that involved an investigational drug within the last 12 months.
- Have a history of delayed or abnormal wound healing
- Are pregnant or breastfeeding
- Had a transfusion within the past 3 months
- Have or plan to be receive a live vaccination (intranasal influenza measles, mumps, rubella, oral polio, yellow fever, varicella)
- Are unable or unwilling to comply with study protocol or procedures.
- Current use anticoagulation medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Deepa Valvi
Lexington, Kentucky, 40536
Deepa Valvi, DrPH, 8592579443, deepa.valvi@uky.edu
Roberto Gedaly, MD
About this study
This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.
Read the detailed description
Participants will be identified through the Department of Transplantation Surgery at the University of Kentucky. Participants will be pre-screened by the department for entry into the study. The investigator will determine if the participant meets study eligibility requirements.
The purpose of this research is to gather information on how safe and effective of Envarsus® is when compared to twice-daily tacrolimus. The results of this study will be shared with the company providing financial support for the study, the Food and Drug Administration and other federal agencies, if required.
All participants that successfully meeting inclusion criteria will be randomized (like the flipping of coin) to Envarsus vs. Tacrolimus at the time of transplant.
Participants will be randomized to one of two treatment arms. Treatment begins on post-op day 1.
- Treatment: Envarsus® 0.07-0.14 mg/kg/day every morning
- Control: Generic tacrolimus 0.1-0.2 mg/kg/day in 2 divided doses given every 12 hours
The total amount of time a person will be asked to volunteer for this study is 9-18 hours over the next 6 months.
Participants will need to complete 9 study visits each of these visits will take approximately 1-2 hours to complete. Participants will be given medication dosing diaries to complete throughout the study and will undergo 2 kidney biopsies.
Participants will be screened for HIV, Hepatitis B and Hepatitis C viruses.
- Conditions
- End Stage Renal Disease
- Being tested
- Tacrolimus, Envarsus XR
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
0.1-0.2 mg/kg/day orally divided into two doses every 12 hours orally
Envarsus XRDrug
0.07-0.14 mg/kg/day every morning orally
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Active comparator | 0.1 - 0.2 mg/kg/day in 2 divided doses every 12 hours orally Receives: Drug: Tacrolimus |
| Envarsus XR | Experimental | 0.07-0.14 mg/kg/day every morning orally Receives: Drug: Envarsus XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change in the percentage of donor specific antibodies
We will check these donor specific antibodies to: HLA-A, -B and -C; or HLA-DR, -DQ and -DP. We will quantify the expression of these markers by Flow Cytometry analysis and reported as mean fluorescence intensity (MFI) units.
Measured: Time of transplant and six months post-transplant
Changes in the percentage of blood immunologic markers
We will monitor the lymphocyte profile in blood in response to these 2 different treatments. The lymphocyte profile test will be performed by multi-parametric flow cytometry analysis with a panel of specific flourochrome-conjugated antibodies to selectively determine the following sub-populations:
- Circulating T cells: CD4/CD8 rates and determine the following CD4 subpopulations: effector TH1, TH2, TH9, Tfh, and regulatory/suppressor T cells.
- Circulating B cells (number and percentage of naïve, activated, memory and plasma B cells.
- Circulating NK cells (mature and immature)
Measured: Time of transplant and six months post-transplant
Secondary outcomes (1)
Changes in creatinine clearance
Baseline creatinine will be considered the creatinine plasma levels several days after transplantation once the kidney function is stabilized.
Measured: Time of transplant and six 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 posted26 Oct 2017
- Study start28 Mar 2019
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Treatment: Envarsus® 0.07-0.14 mg/kg/day every morning * Control: Generic tacrolimus 0.1-0.2 mg/kg/day in 2 divided doses given every 12 hours
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roberto Gedaly
- Sponsor type
- University, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Roberto Gedaly, University of Kentucky
- Investigators
- Roberto Gedaly, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321656
- Sponsor's protocol ID
- 42753
- Status last verified
- Mar 2026
- First submitted
- 28 Sep 2017
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
- ClinicalTrials.gov ID
- NCT03321656
- Acronym / sponsor ID
- 42753
- Conditions
- End Stage Renal Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Roberto GedalyUniversity, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.
Detailed description
Participants will be identified through the Department of Transplantation Surgery at the University of Kentucky. Participants will be pre-screened by the department for entry into the study. The investigator will determine if the participant meets study eligibility requirements.
The purpose of this research is to gather information on how safe and effective of Envarsus® is when compared to twice-daily tacrolimus. The results of this study will be shared with the company providing financial support for the study, the Food and Drug Administration and other federal agencies, if required.
All participants that successfully meeting inclusion criteria will be randomized (like the flipping of coin) to Envarsus vs. Tacrolimus at the time of transplant.
Participants will be randomized to one of two treatment arms. Treatment begins on post-op day 1.
- Treatment: Envarsus® 0.07-0.14 mg/kg/day every morning
- Control: Generic tacrolimus 0.1-0.2 mg/kg/day in 2 divided doses given every 12 hours
The total amount of time a person will be asked to volunteer for this study is 9-18 hours over the next 6 months.
Participants will need to complete 9 study visits each of these visits will take approximately 1-2 hours to complete. Participants will be given medication dosing diaries to complete throughout the study and will undergo 2 kidney biopsies.
Participants will be screened for HIV, Hepatitis B and Hepatitis C viruses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Treatment: Envarsus® 0.07-0.14 mg/kg/day every morning * Control: Generic tacrolimus 0.1-0.2 mg/kg/day in 2 divided doses given every 12 hours
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | Active comparator | Drug: Tacrolimus0.1 - 0.2 mg/kg/day in 2 divided doses every 12 hours orally |
| Envarsus XR | Experimental | Drug: Envarsus XR0.07-0.14 mg/kg/day every morning orally |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fluent in English able to understand and provide informed consent.
- End stage renal disease listed for primary solitary kidney transplant.
- Willing to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent.
- Female who are of childbearing potential will be asked to use 2 different medically acceptable methods of contraception for the duration of the study and at least 1 year post-infusion.
Key exclusion criteria (14 listed)
- Previously undergone organ, tissue or cell transplant
- Allergic to Tacrolimus or MMF (Cellcept)
- Chronic use of blood thinners
- Previous chronic use of glucocorticoids or other immunosuppression, or biologic immunomodulators (prescribed for the treatment of serious inflammatory disorders)
- Significant or active infection
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 |
|---|---|---|
| Tacrolimus0.1-0.2 mg/kg/day orally divided into two doses every 12 hours orally | Drug | Tacrolimus |
| Envarsus XR0.07-0.14 mg/kg/day every morning orally | Drug | Envarsus XR |
Primary outcome
1. Change in the percentage of donor specific antibodies
Time frame: Time of transplant and six months post-transplant
We will check these donor specific antibodies to: HLA-A, -B and -C; or HLA-DR, -DQ and -DP. We will quantify the expression of these markers by Flow Cytometry analysis and reported as mean fluorescence intensity (MFI) units.
Changes in the percentage of blood immunologic markers
Time frame: Time of transplant and six months post-transplant
We will monitor the lymphocyte profile in blood in response to these 2 different treatments. The lymphocyte profile test will be performed by multi-parametric flow cytometry analysis with a panel of specific flourochrome-conjugated antibodies to selectively determine the following sub-populations: 1. Circulating T cells: CD4/CD8 rates and determine the following CD4 subpopulations: effector TH1, TH2, TH9, Tfh, and regulatory/suppressor T cells. 2. Circulating B cells (number and percentage of naïve, activated, memory and plasma B cells. 3. Circulating NK cells (mature and immature)
1 secondary outcome
Changes in creatinine clearance
Time frame: Time of transplant and six months post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Roberto Gedaly, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tacrolimus and Envarsus XR in people with End Stage Renal Disease, run by Roberto Gedaly 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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deepa Valvi, DrPH (8592579443, deepa.valvi@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Change in the percentage of donor specific antibodies (time frame: Time of transplant and six months post-transplant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.