Transplant; Failure, KidneyPhase 4NCT02213068
Belatacept 3 Month Post Transplant Conversion Study
A Phase 4 study testing belatacept, Tacrolimus and MPA in people with Transplant; Failure, Kidney and EBV, run by Lorenzo Gallon at 1 site in United States.
Trial summary
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation. The immune system is the body's defense against infection and other disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant; Failure, Kidney, EBV
- What is being tested?
- belatacept, Tacrolimus and MPA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2020
- 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
- Adult ≥ 18 years of age
- Male or Female
- EBV seropositive
- Recipient of renal transplant from living or deceased donor
Who cannot join
- Recipients with EBV serostatus negative or unknown
- History of acute rejection (AR) within 3 months prior to randomization
- History of positive donor specific antibodies (DSA)
- History of antibody mediated rejection
- Positive T-cell lymphocytotoxic cross match
- Proteinuria >1 g/day or > 0.5 g/day if diabetic
Show all 10Show fewer
- Rejection on 3 month post-transplant screening biopsy
- BK nephropathy at 3 months post-transplant screening biopsy
- Positive pregnancy test at the time of randomization in female of child bearing potential
- History of previous transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University, The Comprehensive Transplant Center
Chicago, Illinois, 60611
About this study
Official title: Randomized Conversion Of Epstein-Barr Virus (EBV)+ Kidney Transplant Recipients Of Living Or Standard Criteria Donors At Three Months Post Transplantation To Belatacept With MPA Or Belatacept With Low-Dose Tacrolimus (50% Of Dose) Compared To Patients Remaining On Center Specific Standard Therapy Of Tacrolimus And MPA
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation. The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking the transplanted organ. The primary purpose of this research study is to evaluate the effects of three (3) different immunosuppressive treatments on rejection in post-transplant kidney recipients. This study will test whether switching from tacrolimus to belatacept will improve long-term kidney function.
Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug Administration (FDA) to be used after transplant. All of these medications have been routinely used in kidney recipients here at Northwestern University.
Read more
Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant. However, the use of belatacept in this study is considered investigational as it has not been FDA approved for use beginning at 3 months after transplant.
This study will involve 51 adult kidney transplant recipients at Northwestern.
Read the detailed description
Immunosuppressive therapy with the calcineurin inhibitors (CNI) cyclosporine (CsA) and Tacrolimus (Tac), have radically changed the field of organ transplantation. Ironically, although extensively and effectively used for kidney transplantation and other solid organ transplants, CsA and Tac cause important adverse renal side effects: acute and chronic renal dysfunction, hemolytic-uremic syndrome, hypertension, electrolyte disturbances and tubular acidosis. Chronic nephrotoxicity from CNI has been implicated as a principal cause of post-transplant renal dysfunction and it is characterized by an irreversible and progressive tubular atrophy, interstitial fibrosis, and focal hyalinosis of small renal arteries and arterioles. Attempts to minimize CNIs and their known toxicities have been marginally successful due to unacceptable rates of acute rejection and drug toxicity. Patients are converted to alternative immunosuppressive therapy related to CNI side effects including neurotoxicity, nephrotoxicity, cardiovascular (HTN, hyperlipidemia), metabolic (NODAT), and cosmetic side effects. Furthermore, this class of medications is associated also, by blocking Interleukin 2 (IL2) production, with negative impact on regulatory T cells (Tregs) generation (an important subpopulation of T helper cells that has been associated with positive immunomodulation and donor specific hypo-responsiveness).
Until the approval of Belatacept for adult EBV+ renal transplant recipients, there have been limited alternative immunosuppressive agents available to mitigate drug induced renal impairment. The phase III drug trials of Belatacept in combination with MMF and corticosteroids have resulted in significant and sustained improvement in glomerular filtration rate (GFR) at one year through three years post transplant. The overall safety of belatacept compared to cyclosporine in de novo transplant recipients was similar. However, there was an increased rate and severity of early acute rejection and post-transplant lymphoproliferative disorder (PTLD) of the central nervous system in patients treated with belatacept.
In a phase II switch study conducted by Bristol Myers Squibb (BMS), the incidence of acute rejection at 24 months post conversion was similar in patients remaining on CNI (4%) compared to those converted to belatacept (7%). There were no reported cases of post-transplant lymphoproliferative disorder (PTLD) in this patient population as of two years post randomization. However, one belatacept patient from Mexico developed tuberculosis and there were more non-serious fungal infections in the belatacept treated patients.
Mechanistically, CD28 (Cluster of Differentiation 28) and CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) are important for the function of regulatory T cells (Tregs). Belatacept binds to CD80/CD86 (Cluster of Differentiation 80/Cluster of Differentiation 86) ligands on antigen presenting cells (APCs) preventing CD28 to bind with these ligands and deliver the costimulatory signal to activate the T Cell. CTLA-4 is a related receptor expressed on activated T cells that also recognizes CD80/CD86 (Cluster of Differentiation 80/Cluster of Differentiation 86) and is thus termed co-inhibitory. It transmits both cell intrinsic and cell extrinsic negative signals that impair activation.
Investigation of the effect of early conversion to Belatacept at month 3 post-transplant on the subpopulations of T cells and B cells and peripheral blood and allograft biopsy-derived gene expression subpopulation profiles are planned. Optimization of the Belatacept immunosuppressive regimen to achieve good long term renal function and improved graft survival requires understanding the relationships of these cell populations to clinical outcomes.
- Conditions
- Transplant; Failure, Kidney, EBV
- Being tested
- belatacept, Tacrolimus, MPA
- Keywords
- Kidney, Renal, Transplant, EBV, Immunosuppressants, Belatacept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
belataceptDrug
Also called Belatacept (Nulojix®)
Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
TacrolimusDrug
Also called Tacrolimus (Prograf®)
Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
MPADrug
Also called Mycophenolic Acid (MPA) (Myfortic®)
Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
| Study group | Role | What they receive |
|---|---|---|
| belatacept + MPA | Experimental | subjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus:
Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 40-60% of the previous dose Day 21 (~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue
MPA: administered according to SOC Receives: Drug: belatacept; Drug: MPA |
| belatacept + Low-Dose Tac | Active comparator | Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter.
Tacrolimus tapered over one month as follows:
Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 10% of the previous dose Day 21 (~ 3 weeks into study): 20% of the previous dose Day 30 (~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter. Receives: Drug: belatacept; Drug: Tacrolimus |
| Tacrolimus + MPA standard treatment regimen | Other | Standard of Care treatment regimen:
Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.
MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper.
MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator. Receives: Drug: Tacrolimus; Drug: MPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eGFR (MDRD) at 2 Years Post-transplant Compared to Baseline at Month 3 (Conversion)
To assess change in renal function by calculated (MDRD) GFR of adult EBV seropositive renal transplant recipients of living or standard criteria donors converted from Tacrolimus to Belatacept or low dose Tacrolimus with Belatacept at three months post-operatively compared to renal transplant recipients randomized to remain on standard dose Tacrolimus and MPA for maintenance therapy at 2 years post-transplantation
Measured: 2 years
Acute Rejection
Number of Participants with Acute Rejection (AR). AR is defined as allograft dysfunctions in the setting of recipient immune system engaging an allo-response against the kidney transplant.
Measured: 2 years
Graft Survival
Number of Subjects with a functioning Graft
Measured: 2 years
Patient Survival
Number of Subjects alive at the end of 24 months
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2020
- Study completionSep 2020
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.
- Other trials for Transplant; Failure, KidneyStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lorenzo Gallon
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Lorenzo Gallon, Northwestern University
- Investigators
- Lorenzo Gallon, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213068
- Sponsor's protocol ID
- STU00085274
- Status last verified
- Jan 2023
- First submitted
- 7 Aug 2014
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Conversion Of Epstein-Barr Virus (EBV)+ Kidney Transplant Recipients Of Living Or Standard Criteria Donors At Three Months Post Transplantation To Belatacept With MPA Or Belatacept With Low-Dose Tacrolimus (50% Of Dose) Compared To Patients Remaining On Center Specific Standard Therapy Of Tacrolimus And MPA
- ClinicalTrials.gov ID
- NCT02213068
- Acronym / sponsor ID
- STU00085274
- Conditions
- Transplant; Failure, Kidney, EBV
- Keywords
- Kidney, Renal, Transplant, EBV, Immunosuppressants, Belatacept
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Lorenzo GallonUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jul 2014
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Posted 8 Sep 2021
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 being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months after kidney transplantation. The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking the transplanted organ. The primary purpose of this research study is to evaluate the effects of three (3) different immunosuppressive treatments on rejection in post-transplant kidney recipients. This study will test whether switching from tacrolimus to belatacept will improve long-term kidney function.
Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug Administration (FDA) to be used after transplant. All of these medications have been routinely used in kidney recipients here at Northwestern University.
Belatacept (the "study drug") has been approved by the FDA for use at the time of transplant. However, the use of belatacept in this study is considered investigational as it has not been FDA approved for use beginning at 3 months after transplant.
This study will involve 51 adult kidney transplant recipients at Northwestern.
Detailed description
Immunosuppressive therapy with the calcineurin inhibitors (CNI) cyclosporine (CsA) and Tacrolimus (Tac), have radically changed the field of organ transplantation. Ironically, although extensively and effectively used for kidney transplantation and other solid organ transplants, CsA and Tac cause important adverse renal side effects: acute and chronic renal dysfunction, hemolytic-uremic syndrome, hypertension, electrolyte disturbances and tubular acidosis. Chronic nephrotoxicity from CNI has been implicated as a principal cause of post-transplant renal dysfunction and it is characterized by an irreversible and progressive tubular atrophy, interstitial fibrosis, and focal hyalinosis of small renal arteries and arterioles. Attempts to minimize CNIs and their known toxicities have been marginally successful due to unacceptable rates of acute rejection and drug toxicity. Patients are converted to alternative immunosuppressive therapy related to CNI side effects including neurotoxicity, nephrotoxicity, cardiovascular (HTN, hyperlipidemia), metabolic (NODAT), and cosmetic side effects. Furthermore, this class of medications is associated also, by blocking Interleukin 2 (IL2) production, with negative impact on regulatory T cells (Tregs) generation (an important subpopulation of T helper cells that has been associated with positive immunomodulation and donor specific hypo-responsiveness).
Until the approval of Belatacept for adult EBV+ renal transplant recipients, there have been limited alternative immunosuppressive agents available to mitigate drug induced renal impairment. The phase III drug trials of Belatacept in combination with MMF and corticosteroids have resulted in significant and sustained improvement in glomerular filtration rate (GFR) at one year through three years post transplant. The overall safety of belatacept compared to cyclosporine in de novo transplant recipients was similar. However, there was an increased rate and severity of early acute rejection and post-transplant lymphoproliferative disorder (PTLD) of the central nervous system in patients treated with belatacept.
In a phase II switch study conducted by Bristol Myers Squibb (BMS), the incidence of acute rejection at 24 months post conversion was similar in patients remaining on CNI (4%) compared to those converted to belatacept (7%). There were no reported cases of post-transplant lymphoproliferative disorder (PTLD) in this patient population as of two years post randomization. However, one belatacept patient from Mexico developed tuberculosis and there were more non-serious fungal infections in the belatacept treated patients.
Mechanistically, CD28 (Cluster of Differentiation 28) and CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) are important for the function of regulatory T cells (Tregs). Belatacept binds to CD80/CD86 (Cluster of Differentiation 80/Cluster of Differentiation 86) ligands on antigen presenting cells (APCs) preventing CD28 to bind with these ligands and deliver the costimulatory signal to activate the T Cell. CTLA-4 is a related receptor expressed on activated T cells that also recognizes CD80/CD86 (Cluster of Differentiation 80/Cluster of Differentiation 86) and is thus termed co-inhibitory. It transmits both cell intrinsic and cell extrinsic negative signals that impair activation.
Investigation of the effect of early conversion to Belatacept at month 3 post-transplant on the subpopulations of T cells and B cells and peripheral blood and allograft biopsy-derived gene expression subpopulation profiles are planned. Optimization of the Belatacept immunosuppressive regimen to achieve good long term renal function and improved graft survival requires understanding the relationships of these cell populations to clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| belatacept + MPA | Experimental | Drug: belatacept, Drug: MPAsubjects continue MPA per SOC, receive bimonthly infusions of belatacept while gradually reducing and then discontinuing tacrolimus: Belatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter. Tacrolimus tapered over one month as follows: Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 40-60% of the previous dose Day 21 (~ 3 weeks into study): 20-30% of the previous dose Day 30 (about 1 month): discontinue MPA: administered according to SOC |
| belatacept + Low-Dose Tac | Active comparator | Drug: belatacept, Drug: TacrolimusBelatacept: 5 mg/kg IV on Day 1, 15, 29, 43, and 57 post-conversion, then monthly thereafter. Tacrolimus tapered over one month as follows: Days 1- 14: SOC administration Day 15 (~ 2 weeks into study): 10% of the previous dose Day 21 (~ 3 weeks into study): 20% of the previous dose Day 30 (~ 1 month into study): 20% of the previous dose Target trough level ≤ 5 mg per ml of tacrolimus thereafter. |
| Tacrolimus + MPA standard treatment regimen | Other | Drug: Tacrolimus, Drug: MPAStandard of Care treatment regimen: Tacrolimus: administered orally twice daily (BID) The total initial dose of Tacrolimus is given at 0.1 mg/kg in two divided doses to achieve a stable 12-hour trough level of 8 - 12 ng/mL on Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter. MPA: dosed orally per package insert beginning on the day of transplantation. Methylprednisolone as sodium succinate is administered as 500 mg IV, 250 mg IV, 125 mg IV, on Days 0, 1, and 2 without corticosteroid taper. MPA dose adjustments for gastrointestinal side effects or leukopenia will be made at the discretion of the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult ≥ 18 years of age
- Male or Female
- EBV seropositive
- Recipient of renal transplant from living or deceased donor
Key exclusion criteria (10 listed)
- Recipients with EBV serostatus negative or unknown
- History of acute rejection (AR) within 3 months prior to randomization
- History of positive donor specific antibodies (DSA)
- History of antibody mediated rejection
- Positive T-cell lymphocytotoxic cross match
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 |
|---|---|---|
| belataceptAlso: Belatacept (Nulojix®)Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention | Drug | belatacept + Low-Dose Tac, belatacept + MPA |
| TacrolimusAlso: Tacrolimus (Prograf®)Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention | Drug | Tacrolimus + MPA standard treatment regimen, belatacept + Low-Dose Tac |
| MPAAlso: Mycophenolic Acid (MPA) (Myfortic®)Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention | Drug | Tacrolimus + MPA standard treatment regimen, belatacept + MPA |
Primary outcome
Change in eGFR (MDRD) at 2 Years Post-transplant Compared to Baseline at Month 3 (Conversion)
Time frame: 2 years
To assess change in renal function by calculated (MDRD) GFR of adult EBV seropositive renal transplant recipients of living or standard criteria donors converted from Tacrolimus to Belatacept or low dose Tacrolimus with Belatacept at three months post-operatively compared to renal transplant recipients randomized to remain on standard dose Tacrolimus and MPA for maintenance therapy at 2 years post-transplantation
Acute Rejection
Time frame: 2 years
Number of Participants with Acute Rejection (AR). AR is defined as allograft dysfunctions in the setting of recipient immune system engaging an allo-response against the kidney transplant.
Graft Survival
Time frame: 2 years
Number of Subjects with a functioning Graft
Patient Survival
Time frame: 2 years
Number of Subjects alive at the end of 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lorenzo Gallon, MD principal investigator
Northwestern University
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 belatacept, Tacrolimus and MPA in people with Transplant; Failure, Kidney and EBV, run by Lorenzo Gallon 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 10 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 8 Feb 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 8 Sep 2021). 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?
Change in eGFR (MDRD) at 2 Years Post-transplant Compared to Baseline at Month 3 (Conversion) (time frame: 2 years). The study lists 4 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 8 Feb 2023.