Kidney TransplantationPhase 4NCT03828682
Veloxis de Novo Kidney Transplant ECSWD
A Phase 4 study testing Tacrolimus Extended Release Oral Tablet [Envarsus], Mycophenolate Mofetil and Mycophenolic Acid Oral Product in people with Kidney Transplantation and Immunosuppression, run by Simon Tremblay, PharmD, PhD at 2 sites in United States.
Trial summary
This study is designed to evaluate the safety and efficacy of LCPT in combination with rATG, mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Immunosuppression
- What is being tested?
- Tacrolimus Extended Release Oral Tablet [Envarsus], Mycophenolate Mofetil and Mycophenolic Acid Oral Product
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jun 2019to 30 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Male and female patients ≥ 18 years of age.
- Patient who is receiving a renal transplant from a living or heart-beating deceased donor.
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.
- The patient has given written informed consent to participate in the study
Who cannot join
- Patient has previously received an organ transplant other than a kidney.
- Patient is receiving an HLA identical living donor transplant.
- Patient who is a recipient of a multiple organ transplant.
- Patient has a most recent cytotoxic PRA of >25% or calculated PRA >50% where multiple moderate level HLA antibodies exist and in the opinion of the PI represents substantial HLA sensitization.
- Patient with a positive T or B cell crossmatch that is primarily due to HLA antibodies.
- Patient with a donor specific antibody (DSA) as deemed by the PI to be associated with significant risk of rejection.
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- Patient has received an ABO incompatible donor kidney.
- The deceased donor and/or deceased donor kidney meet any of the following extended criteria for organ donation (ECD):
- Donor age ≥ 60 years OR
- Donor age 50-59 years and 1 of the following:
- Cerebrovascular accident (CVA) + hypertension + SCr > 1.5 mg/dL OR ii. CVA + hypertension OR iii. CVA + SCr > 1.5 mg/dL OR iv. Hypertension + SCr > 1.5 mg/dL OR c. CIT ≥ 24 hours, donor age > 10 years OR d. Donation after cardiac death (DCD)
- Recipients will be receiving a dual or en bloc kidney transplant.
- Donor anticipated cold ischemia is >30hours.
- Recipient that is seropositive for hepatitis C virus (HCV) with detectable Hepatitis C viral load are excluded. HCV seropositive patients with a negative HCV viral load testing may be included.
- Recipients with a positive hepatitis B viral load or positive hepatitis B surface antigen testing within 1 year of consent.
- Hepatitis B surface antibody negative recipients receiving a kidney from a donor seropositive for hepatitis B core antibody or hepatitis B nucleic acid.
- Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
- Recipient who is seronegative for Epstein Barr Virus (EBV)
- Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
- Patients with thrombocytopenia (PLT <75,000/mm3), and/or leukopenia (WBC < 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.
- Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
- Patient who has undergone desensitization therapy within 6 months prior to transplant.
- Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil/mycophenolic acid, rabbit anti-thymocyte globulin, or glucocorticoids.
- Patient is receiving chronic steroid therapy at the time of transplant.
- Patients with a history of cancer (other than non-melanoma skin cell cancers cured by local resection) within the last 5 years, unless they have an expected disease free survival of >95%.
- Patient is pregnant, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
- Women of childbearing potential must use reliable contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy.
- Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
- Inability to cooperate or communicate with the investigator.
- Renal allograft has been reperfused for more than 48 hours at the time of enrollment
- Patient unable to receive intact LCPT formulation
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
The Christ Hospital
Cincinnati, Ohio, 45219
Simon Tremblay, PharmD, PhD, 513-558-9967, simon.tremblay@uc.edu
Adele Rike-Shields, PharmD
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Simon Tremblay, PharmD, PhD, 513-558-9967, simon.tremblay@uc.edu
Rita R Alloway, PharmD
About this study
Official title: A 12-Month, Open Label Study of Extended Release Tacrolimus (Envarsus XR®, LCPT) With Mycophenolate, Rabbit Antithymocyte Globulin (rATG) and Early Steroid Withdrawal in de Novo Kidney Transplant Recipients
This study is designed to evaluate the safety and efficacy of LCPT in combination with rATG, mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant recipients.
- Conditions
- Kidney Transplantation, Immunosuppression
- Being tested
- Tacrolimus Extended Release Oral Tablet [Envarsus], Mycophenolate Mofetil, Mycophenolic Acid Oral Product, Tacrolimus, Methylprednisolone
- Keywords
- tacrolimus, extended release, kidney transplantation, steroid withdrawal, once daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus Extended Release Oral Tablet [Envarsus]Drug
Also called Envarsus XR
Tacrolimus Extended Release Oral Tablet [Envarsus]
Also called Cellcept, MMF
Mycophenolate mofetil capsules or tablets
Mycophenolic Acid Oral ProductDrug
Also called Myfortic, MPA
mycophenolic acid tablets
TacrolimusDrug
Also called Prograf, FK506
Twice daily tacrolimus
Methylprednisolone taper
PrednisoneDrug
Also called Deltasone
Prednisone taper
Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]Drug
Also called Thymoglobulin, rATG
Rabbit Anti-Human T-Lymphocyte Globulin
| Study group | Role | What they receive |
|---|---|---|
| Prospective Arm | Experimental | De novo kidney transplant recipients receiving:
rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Once-daily tacrolimus XR 0.8mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 24-hr trough levels of 8-12ng/mL up to day 30 followed by 24-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery Receives: Drug: Tacrolimus Extended Release Oral Tablet [Envarsus]; Drug: Mycophenolate Mofetil; Drug: Mycophenolic Acid Oral Product; Drug: Methylprednisolone; Drug: Prednisone; Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin] |
| Comparator arm | Active comparator | Historical control arm consisting of the following
De novo kidney transplant recipients receiving:
rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Twice-daily tacrolimus 0.1mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 12-hr trough levels of 8-12ng/mL up to day 30 followed by 12-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery Receives: Drug: Mycophenolate Mofetil; Drug: Mycophenolic Acid Oral Product; Drug: Tacrolimus; Drug: Methylprednisolone; Drug: Prednisone; Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with the combination oral outcome of Biopsy-proven acute rejection, patient death and graft loss
Biopsy-proven acute rejection, patient death and graft loss
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start21 Jun 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective cohort of de novo kidney transplant recipients will be assigned to treatment group and compared to historical controls
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simon Tremblay, PharmD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Simon Tremblay, PharmD, PhD, University of Cincinnati
- Investigators
- Simon Tremblay, PharmD, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03828682
- Sponsor's protocol ID
- 2018-7742
- Status last verified
- May 2020
- First submitted
- 31 Jan 2019
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Month, Open Label Study of Extended Release Tacrolimus (Envarsus XR®, LCPT) With Mycophenolate, Rabbit Antithymocyte Globulin (rATG) and Early Steroid Withdrawal in de Novo Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT03828682
- Acronym / sponsor ID
- 2018-7742
- Conditions
- Kidney Transplantation, Immunosuppression
- Keywords
- tacrolimus, extended release, kidney transplantation, steroid withdrawal, once daily
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Simon Tremblay, PharmD, PhDUniversity, hospital or other
- Collaborators
- Veloxis Pharmaceuticals
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 4 Feb 2019 (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 study is designed to evaluate the safety and efficacy of LCPT in combination with rATG, mycophenolate and early corticosteroid withdrawal (CSWD) in de novo kidney transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective cohort of de novo kidney transplant recipients will be assigned to treatment group and compared to historical controls
| Arm | Type | Receives |
|---|---|---|
| Prospective Arm | Experimental | Drug: Tacrolimus Extended Release Oral Tablet [Envarsus], Drug: Mycophenolate Mofetil, Drug: Mycophenolic Acid Oral Product, Drug: Methylprednisolone, Drug: Prednisone, Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]De novo kidney transplant recipients receiving: rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Once-daily tacrolimus XR 0.8mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 24-hr trough levels of 8-12ng/mL up to day 30 followed by 24-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery |
| Comparator arm | Active comparator | Drug: Mycophenolate Mofetil, Drug: Mycophenolic Acid Oral Product, Drug: Tacrolimus, Drug: Methylprednisolone, Drug: Prednisone, Drug: Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]Historical control arm consisting of the following De novo kidney transplant recipients receiving: rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Twice-daily tacrolimus 0.1mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 12-hr trough levels of 8-12ng/mL up to day 30 followed by 12-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients ≥ 18 years of age.
- Patient who is receiving a renal transplant from a living or heart-beating deceased donor.
- Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.
- The patient has given written informed consent to participate in the study
Key exclusion criteria (31 listed)
- Patient has previously received an organ transplant other than a kidney.
- Patient is receiving an HLA identical living donor transplant.
- Patient who is a recipient of a multiple organ transplant.
- Patient has a most recent cytotoxic PRA of >25% or calculated PRA >50% where multiple moderate level HLA antibodies exist and in the opinion of the PI represents substantial HLA sensitization.
- Patient with a positive T or B cell crossmatch that is primarily due to HLA antibodies.
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 |
|---|---|---|
| Tacrolimus Extended Release Oral Tablet [Envarsus]Also: Envarsus XRTacrolimus Extended Release Oral Tablet [Envarsus] | Drug | Prospective Arm |
| Mycophenolate MofetilAlso: Cellcept, MMFMycophenolate mofetil capsules or tablets | Drug | Comparator arm, Prospective Arm |
| Mycophenolic Acid Oral ProductAlso: Myfortic, MPAmycophenolic acid tablets | Drug | Comparator arm, Prospective Arm |
| TacrolimusAlso: Prograf, FK506Twice daily tacrolimus | Drug | Comparator arm |
| MethylprednisoloneMethylprednisolone taper | Drug | Comparator arm, Prospective Arm |
| PrednisoneAlso: DeltasonePrednisone taper | Drug | Comparator arm, Prospective Arm |
| Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]Also: Thymoglobulin, rATGRabbit Anti-Human T-Lymphocyte Globulin | Drug | Comparator arm, Prospective Arm |
Primary outcome
Proportion of patients with the combination oral outcome of Biopsy-proven acute rejection, patient death and graft loss
Time frame: 12 months
Biopsy-proven acute rejection, patient death and graft loss
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- 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. This study is not recruiting at the moment.
Simon Tremblay, PharmD, PhD principal investigator
University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus Extended Release Oral Tablet [Envarsus], Mycophenolate Mofetil and Mycophenolic Acid Oral Product in people with Kidney Transplantation and Immunosuppression, run by Simon Tremblay, PharmD, PhD at 2 sites 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 31 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: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Tremblay, PharmD, PhD (513-558-9967, tremblsn@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with the combination oral outcome of Biopsy-proven acute rejection, patient death and graft loss (time frame: 12 months). 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 13 May 2020.