Kidney TransplantationPhase 4SIMPLENCT04773392

Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR

A Phase 4 study testing Twice-daily Tacrolimus, Once-daily envarsus XR and Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) in people with Kidney Transplantation and Kidney Transplant Rejection, run by University of Southern California at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to determine if the combination of once-daily tacrolimus extended-release (EnvarsusXR) and Azathioprine is non inferior with respect to the composite outcome of acute rejection, graft and patient survival as compared to a combination of twice-daily immediate release tacrolimus and… Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Kidney Transplantation, Kidney Transplant Rejection
What is being tested?: Twice-daily Tacrolimus, Once-daily envarsus XR and Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 23 Nov 2021to 23 Feb 2024
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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

De- Novo Kidney transplant patients between 18 and 85 years old
Cold ischemia time (CIT) < 24 hours for 3-6 HLA mismatches between donor and recipient and CIT >24 hours for HLA mismatch of less than 3 between donor and recipient
Most recent pre-transplant cPRA (calculated panel reactive antibody) ≤ 20%

Who cannot join

Repeat kidney transplant recipients
cPRA >20%
rATG (rabbit anti-thymocyte globulin) induction >6mg/kg at time of induction
Crossmatches deemed positive by accepting physician
Presence of pre-formed anti-HLA (anti-Human Leukocyte Antigen) DSA (Donor-Specific Antibody) as defined by MFI (mean fluorescence intensity) approaching 3000 using flow cytometry/Luminex-based, specific anti-HLA antibody testing.
Receipt of desensitization protocols

Show all 9Show fewer

History of skin cancer
Recipient of multi-organ or dual kidney transplants
For any condition, in which the investigator's opinion makes the subject unsuitable for study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Southern California
Los Angeles, California, 90033

Other trials in United States

About this study

Official title: SIMPLE Study: A Prospective and Randomized Trial of a Simplified Immunosuppressive Protocol Utilizing Low Dose EnvarsusXR

Read the detailed description

While short-term graft outcomes in kidney transplantation have improved, this requires adherence to a complex medication regimen. The current twice-daily immunosuppressive regimen, immediate release tacrolimus and mycophenolate mofetil/mycophenolic acid, has reduced rejection rates significantly, but frequently cause neurologic and gastrointestinal side effects which impact recipient quality of life. These side effects often require dose adjustments and studies have shown inferior outcomes when multiple changes are made to the immunosuppressive regimen. Furthermore, patients taking twice-daily medications have poorer compliance and yet adherence to these medications is critical to mitigate the risk of allograft rejection. Acute and chronic rejection are important causes of graft failure and patient survival.

Immediate release (IR) tacrolimus based immunosuppressive regimens have become the standard of care at most US centers. With the introduction of a once-daily tacrolimus formulation, kidney transplant recipients can now be on a combination regimen (EnvarsusXR and azathioprine) that permits all immunosuppressive medications to be taken once a day instead of twice . Previous studies suggest that therapeutic goals with EnvarsusXR may be achieved at a lower dose than the currently recommended dose. This once a day medication schedule has the potential to simplify the immunosuppressive regimen by reducing adverse side effects and facilitating compliance.

The investigators seek to demonstrate that a once-daily regimen, including EnvarsusXR and azathioprine, will be at least equally effective with respect to acute rejection, graft and patient survival as compared to the standard, twice-daily, immediate release tacrolimus and mycophenolate mofetil/mycophenolic acid. The investigators will also assess graft function, medication complications and side effects in each arm.

Conditions: Kidney Transplantation, Kidney Transplant Rejection
Being tested: Twice-daily Tacrolimus, Once-daily envarsus XR, Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG), Methylprednisolone, prednisone, Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)
Keywords: tacrolimus, envarsus XR, kidney transplant, rejection, immunosuppressive agents, renal transplant
Medical subject headings: Rejection, Psychology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Twice-daily TacrolimusDrug
Also called immediate release tacrolimus
Within 48 hours of transplantation, immediate release tacrolimus (IRT) (0.1 mg/kg /day) will be administered twice a day.
Once-daily envarsus XRDrug
Also called extended releated tacrolimus
Within 48 hours of transplantation, Envarsus XR (0.13mg/kg/day) will be administered once a day.
Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)Drug
Also called Simulect, ATG
Induction immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) per protocol. The dose of Basiliximab will be a standard of two 20 mg doses and total rATG will not exceed 6 mg/kg.
Methylprednisolone, prednisoneDrug
Also called Steroids
Methylprednisolone intraoperatively (500mg) and immediately post transplantation (200mg on post operative day (POD) #1, 150mg on POD#2, 100mg on POD#3) then oral prednisone (50mg on POD #4, 20mg on POD #5). Oral prednisone will be tapered down to a minimal dose of 5mg within 6 weeks post transplantation.
Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)Drug
Also called Twice a day anti-metabolite
Mycophenolate mofetil (MMF) (up to 1000mg) or Mycophenolic acid (MPA) (up to 720mg) will be administered twice a day.
AzathioprineDrug
Also called Once a day anti-metabolite
Azathioprine (1-3 mg/kg) will be administered once a day.

Study groups in NCT04773392
Study group	Role	What they receive
Twice-daily Regimen	Active comparator	Twice-daily regimen of immediate release tacrolimus, mycophenolate mofetil (MMF)/mycophenolic acid (MPA) plus daily methylprednisolone or prednisone. Receives: Drug: Twice-daily Tacrolimus; Drug: Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG); Drug: Methylprednisolone, prednisone; Drug: Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)
Once-daily Regimen	Active comparator	Once-daily regimen of Envarsus, azathioprine plus methylprednisolone or prednisone. Receives: Drug: Once-daily envarsus XR; Drug: Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG); Drug: Methylprednisolone, prednisone; Drug: Azathioprine

What is being measured

The primary outcome is the main question the study is designed to answer.

To compare the composite incidence of biopsy proven acute rejection, graft survival and patient survival
Biopsies will be performed for unexplained rise in serum creatinine or proteinuria and the development of donor specific antibodies. Biopsies will be assessed by a pathologist using standard Banff classification of renal allograft pathology. Graft loss will be defined as return to chronic dialysis or graft removal.
Measured: 3 months
To compare the composite incidence of biopsy proven acute rejection, graft survival and patient survival
Biopsies will be performed for unexplained rise in serum creatinine or proteinuria and the development of donor specific antibodies. Biopsies will be assessed by a pathologist using standard Banff classification of renal allograft pathology. Graft loss will be defined as return to chronic dialysis or graft removal.
Measured: 6 months
To compare the composite incidence of biopsy proven acute rejection, graft survival and patient survival
Biopsies will be performed for unexplained rise in serum creatinine or proteinuria and the development of donor specific antibodies. Biopsies will be assessed by a pathologist using standard Banff classification of renal allograft pathology. Graft loss will be defined as return to chronic dialysis or graft removal.
Measured: 12 months

Secondary outcomes (15)

Renal allograft function
Estimated glomerular filtration rate (eGFR)
Measured: Every month, for a duration of 12 months
Proteinuria
Urinalysis
Measured: Every month, for a duration of 12 months
Donor-specific antibodies (DSA)
Donor-specific anti-HLA antibodies, with a MFI (mean fluorescence intensity) >1000, measured by flow cytometry/Luminex-based assay
Measured: 3, 6, and 12 months
Cytomegalovirus (CMV)
CMV PCR
Measured: 3, 6, and 12 months
Liver Function
Alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase
Measured: 3, 6, and 12 months
Gastrointestinal side effects
GI side effects will be assessed by the Gastrointestinal Symptoms Rating Scale (GSRS) is a 15 item questionnaire addressing reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.
Measured: 3, 6, and 12 months
Dyspepsia and quality of life
The Quality of Life in Reflux and Dyspepsia (QOLRAD) is a 25 item instrument depicting problems with emotions, vitality, sleep, eating/drinking, and physical/social functioning in adult patients with reflux disease. The questions are rated on a seven-point graded Likert scale; lower values indicate a more severe impact on daily functioning.
Measured: 3, 6, and 12 months
Tremor
Tremor will be assessed by Quality of life in Essential Tremor Questionnaire, (QUEST) a 30-item scale developed specifically for patients with essential tremor to measure items impacting perceived quality of life (QOL). The items are rated on a five-point scale (score 0-4), corresponding to the frequency (never, rarely, sometimes, frequently, always) with which tremor was perceived to currently impact a function or to be associated with various feelings and attitudes
Measured: 3, 6, and 12 months
Perception of quality of life
The Short Form (36) Healthy Survey (SF-36) is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being.Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Measured: 3, 6, and 12 months
Cancer
Incidence of cancers
Measured: 3, 6, and 12 months
Diabetes
Incidence of new onset diabetes measured by HgbA1c
Measured: 3, 6, and 12 months
Electrolytes
Dose of magnesium, potassium and phosphorus needed to replete electrolytes
Measured: 3, 6, and 12 months
Adverse Events
An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use the product, whether or not related to the product.
Measured: 3, 6, and 12 months
Dose changes
Frequency of dose changes made in Envarsus, tacrolimus and MMF/MPA. Dosage changes will be adjusted for Tacrolimus drug levels as per protocol. MMF/MPA will be adjusted depending on gastrointestinal tolerability and bone marrow suppression.
Measured: 3, 6, and 12 months
BK Viremia
BK quantitative serum assay
Measured: 3, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Nov 202123 Feb 2024

First posted26 Feb 2021
Study start23 Nov 2021
Primary completion23 Feb 2024
Study completion23 Feb 2024

Why it stopped: Research contract expired

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Model description: This is an open-label, randomized, prospective clinical trial. Patients will be screened prior to surgery and randomized 1:1 to each arm.
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04773392
Sponsor's protocol ID: HS-18-00513
Acronym: SIMPLE
Status last verified: Nov 2025
First submitted: 15 Feb 2021
Last updated: 10 Nov 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Park SI, Felipe CR, Pinheiro-Machado PG, Garcia R, Fernandes FB, Casarini DE, Tedesco-Silva H Jr, Medina-Pestana JO. Tacrolimus pharmacokinetic drug interactions: effect of prednisone, mycophenolic acid or sirolimus. Fundam Clin Pharmacol. 2009 Feb;23(1):137-45. doi: 10.1111/j.1472-8206.2008.00644.x.
PubMed 19267777
Dalal P, Shah G, Chhabra D, Gallon L. Role of tacrolimus combination therapy with mycophenolate mofetil in the prevention of organ rejection in kidney transplant patients. Int J Nephrol Renovasc Dis. 2010;3:107-15. doi: 10.2147/ijnrd.s7044. Epub 2010 Aug 4.
PubMed 21694936
Kulich KR, Madisch A, Pacini F, Pique JM, Regula J, Van Rensburg CJ, Ujszaszy L, Carlsson J, Halling K, Wiklund IK. Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study. Health Qual Life Outcomes. 2008 Jan 31;6:12. doi: 10.1186/1477-7525-6-12.
PubMed 18237386
Troster AI, Pahwa R, Fields JA, Tanner CM, Lyons KE. Quality of life in Essential Tremor Questionnaire (QUEST): development and initial validation. Parkinsonism Relat Disord. 2005 Sep;11(6):367-73. doi: 10.1016/j.parkreldis.2005.05.009.
PubMed 16103000

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SIMPLE Study: A Prospective and Randomized Trial of a Simplified Immunosuppressive Protocol Utilizing Low Dose EnvarsusXR
ClinicalTrials.gov ID: NCT04773392
Acronym / sponsor ID: SIMPLE / HS-18-00513
Conditions: Kidney Transplantation, Kidney Transplant Rejection
Keywords: tacrolimus, envarsus XR, kidney transplant, rejection, immunosuppressive agents, renal transplant
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Research contract expired
Enrolment: 20 participants (actual)
Lead sponsor: University of Southern CaliforniaUniversity, hospital or other
Collaborators: Veloxis Pharmaceuticals
Study start: 23 Nov 2021 (actual)
Primary completion: 23 Feb 2024 (actual)
Study completion: 23 Feb 2024 (actual)
First posted: 26 Feb 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This is an open-label, randomized, prospective clinical trial. Patients will be screened prior to surgery and randomized 1:1 to each arm.

Arm	Type	Receives
Twice-daily Regimen	Active comparator	Drug: Twice-daily Tacrolimus, Drug: Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG), Drug: Methylprednisolone, prednisone, Drug: Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)Twice-daily regimen of immediate release tacrolimus, mycophenolate mofetil (MMF)/mycophenolic acid (MPA) plus daily methylprednisolone or prednisone.
Once-daily Regimen	Active comparator	Drug: Once-daily envarsus XR, Drug: Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG), Drug: Methylprednisolone, prednisone, Drug: AzathioprineOnce-daily regimen of Envarsus, azathioprine plus methylprednisolone or prednisone.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

De- Novo Kidney transplant patients between 18 and 85 years old
Cold ischemia time (CIT) < 24 hours for 3-6 HLA mismatches between donor and recipient and CIT >24 hours for HLA mismatch of less than 3 between donor and recipient
Most recent pre-transplant cPRA (calculated panel reactive antibody) ≤ 20%

Key exclusion criteria (9 listed)

Repeat kidney transplant recipients
cPRA >20%
rATG (rabbit anti-thymocyte globulin) induction >6mg/kg at time of induction
Crossmatches deemed positive by accepting physician
Presence of pre-formed anti-HLA (anti-Human Leukocyte Antigen) DSA (Donor-Specific Antibody) as defined by MFI (mean fluorescence intensity) approaching 3000 using flow cytometry/Luminex-based, specific anti-HLA antibody testing.

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
Twice-daily TacrolimusAlso: immediate release tacrolimusWithin 48 hours of transplantation, immediate release tacrolimus (IRT) (0.1 mg/kg /day) will be administered twice a day.	Drug	Twice-daily Regimen
Once-daily envarsus XRAlso: extended releated tacrolimusWithin 48 hours of transplantation, Envarsus XR (0.13mg/kg/day) will be administered once a day.	Drug	Once-daily Regimen
Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)Also: Simulect, ATGInduction immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) per protocol. The dose of Basiliximab will be a standard of two 20 mg doses and total rATG will not exceed 6 mg/kg.	Drug	Once-daily Regimen, Twice-daily Regimen
Methylprednisolone, prednisoneAlso: SteroidsMethylprednisolone intraoperatively (500mg) and immediately post transplantation (200mg on post operative day (POD) #1, 150mg on POD#2, 100mg on POD#3) then oral prednisone (50mg on POD #4, 20mg on POD #5). Oral prednisone will be tapered down to a minimal dose of 5mg within 6 weeks post transplantation.	Drug	Once-daily Regimen, Twice-daily Regimen
Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)Also: Twice a day anti-metaboliteMycophenolate mofetil (MMF) (up to 1000mg) or Mycophenolic acid (MPA) (up to 720mg) will be administered twice a day.	Drug	Twice-daily Regimen
AzathioprineAlso: Once a day anti-metaboliteAzathioprine (1-3 mg/kg) will be administered once a day.	Drug	Once-daily Regimen

Primary outcome

To compare the composite incidence of biopsy proven acute rejection, graft survival and patient survival
Time frame: 3 months
Biopsies will be performed for unexplained rise in serum creatinine or proteinuria and the development of donor specific antibodies. Biopsies will be assessed by a pathologist using standard Banff classification of renal allograft pathology. Graft loss will be defined as return to chronic dialysis or graft removal.
To compare the composite incidence of biopsy proven acute rejection, graft survival and patient survival
Time frame: 6 months
Biopsies will be performed for unexplained rise in serum creatinine or proteinuria and the development of donor specific antibodies. Biopsies will be assessed by a pathologist using standard Banff classification of renal allograft pathology. Graft loss will be defined as return to chronic dialysis or graft removal.
To compare the composite incidence of biopsy proven acute rejection, graft survival and patient survival
Time frame: 12 months
Biopsies will be performed for unexplained rise in serum creatinine or proteinuria and the development of donor specific antibodies. Biopsies will be assessed by a pathologist using standard Banff classification of renal allograft pathology. Graft loss will be defined as return to chronic dialysis or graft removal.

15 secondary outcomes

Renal allograft function
Time frame: Every month, for a duration of 12 months
Proteinuria
Time frame: Every month, for a duration of 12 months
Donor-specific antibodies (DSA)
Time frame: 3, 6, and 12 months
Cytomegalovirus (CMV)
Time frame: 3, 6, and 12 months
Liver Function
Time frame: 3, 6, and 12 months
Gastrointestinal side effects
Time frame: 3, 6, and 12 months
Dyspepsia and quality of life
Time frame: 3, 6, and 12 months
Tremor
Time frame: 3, 6, and 12 months
Perception of quality of life
Time frame: 3, 6, and 12 months
Cancer
Time frame: 3, 6, and 12 months
Diabetes
Time frame: 3, 6, and 12 months
Electrolytes
Time frame: 3, 6, and 12 months
Adverse Events
Time frame: 3, 6, and 12 months
Dose changes
Time frame: 3, 6, and 12 months
BK Viremia
Time frame: 3, 6, 12 months

Results and safety

The study was stopped early (reason given: Research contract expired). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
Background: PubMed 19267777Park SI, Felipe CR, Pinheiro-Machado PG, Garcia R, Fernandes FB, Casarini DE, Tedesco-Silva H Jr, Medina-Pestana JO. Tacrolimus pharmacokinetic drug interactions: effect of prednisone, mycophenolic acid or sirolimus. Fundam Clin Pharmacol. 2009 Feb;23(1):137-45. doi: 10.1111/j.1472-8206.2008.00644.x.
Background: PubMed 21694936Dalal P, Shah G, Chhabra D, Gallon L. Role of tacrolimus combination therapy with mycophenolate mofetil in the prevention of organ rejection in kidney transplant patients. Int J Nephrol Renovasc Dis. 2010;3:107-15. doi: 10.2147/ijnrd.s7044. Epub 2010 Aug 4.
Background: PubMed 18237386Kulich KR, Madisch A, Pacini F, Pique JM, Regula J, Van Rensburg CJ, Ujszaszy L, Carlsson J, Halling K, Wiklund IK. Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study. Health Qual Life Outcomes. 2008 Jan 31;6:12. doi: 10.1186/1477-7525-6-12.
Background: PubMed 16103000Troster AI, Pahwa R, Fields JA, Tanner CM, Lyons KE. Quality of life in Essential Tremor Questionnaire (QUEST): development and initial validation. Parkinsonism Relat Disord. 2005 Sep;11(6):367-73. doi: 10.1016/j.parkreldis.2005.05.009.
Prescribing informationLink provided by the sponsor.
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.

Santhi Voora, MD principal investigator

University of Southern California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 10 Nov 2025. 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?

The study was stopped early (reason given: Research contract expired). Results are not available in the source record.

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?

To compare the composite incidence of biopsy proven acute rejection, graft survival and patient survival (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT04773392, which also lists 4 linked publications.

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 10 Nov 2025.