Prophylaxis Against Liver Transplant RejectionPhase 4NCT04720326
Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients
A Phase 4 study testing Tacrolimus Pill and Tacrolimus capsule in people with Prophylaxis Against Liver Transplant Rejection, run by Edward Geissler at 15 sites in Germany.
Trial summary
Trial participants are randomised within 14 days after liver transplantation surgery in a 1:1 ratio to two alternative treatment arms containing either Envarsus® (test arm) or Advagraf® (comparator arm) as first-line calcineurin inhibitor within a standard-of-care immunosuppressive regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prophylaxis Against Liver Transplant Rejection
- What is being tested?
- Tacrolimus Pill and Tacrolimus capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 15 sitesGermany
- Study dates
- 23 Dec 2020to 29 Oct 2026
- 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
- Signed and dated written informed consent
- Adult (≥18 years old) male or female
- Recipient of a whole liver transplant from a deceased donor or a split liver transplant from a deceased or living donor
- ABO blood type compatible with the organ donor
- Able to swallow an oral formulation of tacrolimus in tablet or capsule form
Who cannot join
- Multi-organ transplantation
- Any previous organ allograft transplantation
- Biopsy-proven acute rejection that is ongoing at the time of randomisation
- Occurrence of post-transplant thrombosis, occlusion or stent placement in any major hepatic arteries, hepatic veins, portal vein or inferior vena cava
- History of extra-hepatic malignancy that could not be curatively treated
- Hepatocellular carcinoma with extra-hepatic spread or macrovascular invasion
Show all 16Show fewer
- Uncontrolled systemic infection
- Requirement of life support measures such as ventilation or vasopressor agents (>20 µg/kg body weight/h) at the time of randomisation
- Known contraindication or hypersensitivity to tacrolimus, and/or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics of both Envarsus® and Advagraf®, and/or to any other macrolides
- Ongoing, planned or foreseeable use of cyclosporine or any tacrolimus preparation other than Envarsus® or Advagraf® (except for immediate-release formulations administered before randomisation)
- Any prolonged-release tacrolimus treatment prior to randomisation
- Pregnant or nursing (lactating) female, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test
- Female of child-bearing potential, defined as physiologically capable of becoming pregnant, unless using a reliable method of contraception
- Participation in another interventional clinical trial during the time period from randomisation to study end, if the trial is testing an Investigational Medicinal Product or if the intervention and/or follow-up requirements of the trial impede or interfere with either the objectives of EnGraft or the treatment / follow-up requirements of EnGraft
- Any condition or factor which, in the judgement of the investigator, would place the subject at undue risk, invalidate communication with the investigator or study team, or hamper compliance with the trial protocol or follow-up schedule
- Inability to freely give informed consent (e.g. individuals under legal guardianship)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites
University Hospital Aachen
Aachen, 52074
Charite - University Medicine Berlin
Berlin, 13353
University Hospital Essen
Essen, 45147
University Hospital Frankfurt
Frankfurt, 60590
University Hospital Hamburg Eppendorf
Hamburg, 20246
Hannover Medical School
Hanover, 30625
University Hospital Heidelberg
Heidelberg, 69120
University Hospital Jena
Jena, 07747
University Hospital Schleswig-Holstein - Campus Kiel
Kiel, 24105
University Hospital Leipzig
Leipzig, 04103
University Hospital Magdeburg
Magdeburg, 39120
University Hospital Mainz
Mainz, 55131
University Hospital Muenster
Münster, 48149
University Hospital Regensburg
Regensburg, 93053
University Hospital Tuebingen
Tübingen, 72076
About this study
Official title: Multicentre, Open-Label, Randomised, Two-Arm, Parallel-Group, Superiority Study to Assess Bioavailability and Practicability of Envarsus® Compared With Advagraf® in de Novo Liver Transplant Recipients (EnGraft)
Trial participants are randomised within 14 days after liver transplantation surgery in a 1:1 ratio to two alternative treatment arms containing either Envarsus® (test arm) or Advagraf® (comparator arm) as first-line calcineurin inhibitor within a standard-of-care immunosuppressive regimen. Tacrolimus blood trough levels and drug doses are monitored at regular intervals to assess drug bioavailability and the ease and accuracy of achieving the targeted blood concentration range. Dose-normalised trough level (concentration/dose ratio) is measured at 12 weeks post-randomisation as an estimate of tacrolimus bioavailability. It is hypothesised that treatment with Envarsus® will confer a superior (higher) C/D ratio after 12 weeks of therapy owing to the superior bioavailability of this galenic drug formulation (proprietary MeltDose® technology). To test whether an elevated C/D ratio is also associated with improved clinical outcomes, a range of other pharmacokinetic, efficacy and safety variables are evaluated at 10 study visits spanning a period of 3 years.
- Being tested
- Tacrolimus Pill, Tacrolimus capsule
- Keywords
- Liver transplantation, Tacrolimus, Concentration/dose ratio, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus PillDrug
Also called Envarsus
Envarsus® tablets dosed to achieve and maintain whole blood trough levels of tacrolimus within a patient-specific therapeutic range (interval of 3 ng/ml) that lies within a wider reference range of 3-12 ng/ml.
Tacrolimus capsuleDrug
Also called Advagraf
Advagraf® capsules dosed to achieve and maintain whole blood trough levels of tacrolimus within a patient-specific therapeutic range (interval of 3 ng/ml) that lies within a wider reference range of 3-12 ng/ml.
| Study group | Role | What they receive |
|---|---|---|
| Envarsus® | Experimental | Participants take prolonged-release tacrolimus tablets orally once daily and additionally receive standard-of-care immunosuppressive background therapy as per routine practice. Receives: Drug: Tacrolimus Pill |
| Advagraf® | Active comparator | Participants take prolonged-release tacrolimus capsules orally once daily and additionally receive standard-of-care immunosuppressive background therapy as per routine practice. Receives: Drug: Tacrolimus capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-normalised blood trough level of tacrolimus (concentration/dose ratio)
To calculate C/D ratio, "concentration" is the blood trough level of tacrolimus measured in a blood sample collected immediately prior to drug dosing on the day of the 12-week trial visit and "dose" is the daily dose taken by the patient on the day prior to the visit. C/D ratio is measured as a surrogate for tacrolimus bioavailability (i.e. systemic exposure per mg of drug).
Measured: 12 weeks post-randomisation
Secondary outcomes (35)
Number of IMP dose adjustments
Measured: Until 12 weeks post-randomisation
Time to reach the first defined range in target trough level
Measured: Time period measured in days, assessed at 12 weeks post-randomisation
Number of measurements above and below the first defined range in target trough level
Measured: Time period measured in days, assessed at 12 weeks post-randomisation
Dose-normalised trough level (C/D ratio) during long-term follow-up
Measured: 1, 2 and 3 years post-randomisation
Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels
Measured: 1, 2, 4 and 12 weeks post-randomisation
Inter-patient variability (range) of tacrolimus total daily dose
Measured: Until 12 weeks post-randomisation
Proportion of patients with trough levels lower, within, or higher than the standard reference range
Measured: 1, 2, 4 and 12 weeks post-randomisation
Incidence and severity of clinically-confirmed biopsy-proven acute rejection
Measured: 12 weeks and 1, 2, 3 years post-randomisation
Incidence of graft failure (defined as necessity for re-transplantation)
Measured: 12 weeks and 1, 2, 3 years post-randomisation
Incidence of death (for any reason)
Measured: 12 weeks and 1, 2, 3 years post-randomisation
Treatment failure rate (composite endpoint of biopsy-proven acute rejection, graft failure or death)
Measured: 12 weeks and 1, 2, 3 years post-randomisation
Time to treatment failure (composite endpoint of biopsy-proven acute rejection, graft failure or death) after randomisation
Measured: 3 years post-randomisation
Incidence of acute rejections requiring treatment
Measured: 12 weeks post-randomisation
Incidence of multiple rejection episodes
Measured: 12 weeks post-randomisation
Change versus baseline in laboratory measures of liver function (aspartate transaminase, alanine transaminase, alkaline phosphatase, gamma-glutamyltransferase, bilirubin, albumin, cholinesterase, INR)
Measured: 12 weeks and 1, 2, 3 years post-randomisation
Change versus baseline in laboratory measures of metabolic profile (triglycerides, HDL cholesterol, LDL cholesterol, total cholesterol, HbA1c, fasting plasma glucose)
Measured: 12 weeks and 1, 2, 3 years post-randomisation
Change versus baseline in laboratory measures of renal function (creatinine, estimated glomerular filtration rate)
Measured: 12 weeks and 1, 2, 3 years post-randomisation
Incidence and type of malignancies diagnosed in trial participants
Measured: 1, 2 and 3 years post-randomisation
Incidence and type of infections (hepatitis C virus, hepatitis B virus, cytomegalovirus, Epstein-Barr virus) experienced by trial participants
Measured: 1, 2 and 3 years post-randomisation
Degree of liver fibrosis (fibroscan or biopsy)
Measured: 12 weeks and 1, 2, 3 years post-randomisation
Incidence, type, severity, seriousness and causality of adverse events (AEs)
Measured: 3 years post-randomisation
Change versus baseline in heart rate
Measured: 3 years post-randomisation
Change versus baseline in blood pressure
Measured: 3 years post-randomisation
Change versus baseline in body weight
Measured: 3 years post-randomisation
Incidence of de novo occurrence of tremor or vision impairments
Measured: 3 years post-randomisation
Incidence of post-transplant diabetes mellitus and post-transplant hyperglycaemia
Measured: 12 weeks and 1, 2, 3 years post-randomisation
Dose-normalised trough level (C/D ratio)
Measured: 12 weeks post-transplantation
Number and doses of immunosuppressive medications (incl. other tacrolimus formulations)
Measured: At 12 weeks and after 12 weeks (if applicable)
Recurrence of primary hepatic disease
Measured: 3 years post-randomisation
Incidence of donor-specific antibodies
Measured: 12 weeks and 1, 2, 3 years post-randomisation
Continuation rate
Measured: 12 weeks post-randomisation
Incidence and time to study treatment discontinuation
Measured: 3 years post-randomisation
Incidence of patient withdrawal from the study
Measured: 3 years post-randomisation
Time to patient withdrawal from the study
Measured: 3 years post-randomisation
Reason for patient withdrawal from the study
Measured: 3 years post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start23 Dec 2020
- Primary completion25 Jan 2024
- Study completion29 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prophylaxis Against Liver Transplant RejectionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A dynamic allocation technique allocates participants in a 1:1 ratio to one of two treatment arms: Envarsus® tablets (test IMP) or Advagraf® capsules (comparator IMP). Pre-treatment with immediate-release tacrolimus, as well as trial site, are used as stratification factors in the treatment allocation in order to minimise sources of treatment bias.
- Masking
- None (open label)
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Geissler
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi Pharmaceuticals GmbH, Excelya
- Responsible party
- Sponsor-investigator, Edward Geissler, University of Regensburg
- Investigators
- Hans J. Schlitt, MD, Principal investigator, University Hospital Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720326
- Sponsor's protocol ID
- EnGraft
- Other IDs
- 2024-518033-28-00, 2020-000796-20
- Status last verified
- Nov 2026
- First submitted
- 15 Dec 2020
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wohl DS, James B, Gotz M, Brennfleck F, Holub-Hayles I, Mutzbauer I, Baccar S, Brunner SM, Geissler EK, Schlitt HJ; EnGraft Trial Group. EnGraft: a multicentre, open-label, randomised, two-arm, superiority study protocol to assess bioavailability and practicability of Envarsus(R) versus Advagraf in liver transplant recipients. Trials. 2023 May 11;24(1):325. doi: 10.1186/s13063-023-07344-7.
PubMed 37170284
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Open-Label, Randomised, Two-Arm, Parallel-Group, Superiority Study to Assess Bioavailability and Practicability of Envarsus® Compared With Advagraf® in de Novo Liver Transplant Recipients (EnGraft)
- ClinicalTrials.gov ID
- NCT04720326
- Acronym / sponsor ID
- EnGraft
- Keywords
- Liver transplantation, Tacrolimus, Concentration/dose ratio, Immunosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Edward GeisslerUniversity, hospital or other
- Collaborators
- Chiesi Pharmaceuticals GmbH, Excelya
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 29 Oct 2026 (actual)
- First posted
- 22 Jan 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.
Trial participants are randomised within 14 days after liver transplantation surgery in a 1:1 ratio to two alternative treatment arms containing either Envarsus® (test arm) or Advagraf® (comparator arm) as first-line calcineurin inhibitor within a standard-of-care immunosuppressive regimen. Tacrolimus blood trough levels and drug doses are monitored at regular intervals to assess drug bioavailability and the ease and accuracy of achieving the targeted blood concentration range. Dose-normalised trough level (concentration/dose ratio) is measured at 12 weeks post-randomisation as an estimate of tacrolimus bioavailability. It is hypothesised that treatment with Envarsus® will confer a superior (higher) C/D ratio after 12 weeks of therapy owing to the superior bioavailability of this galenic drug formulation (proprietary MeltDose® technology). To test whether an elevated C/D ratio is also associated with improved clinical outcomes, a range of other pharmacokinetic, efficacy and safety variables are evaluated at 10 study visits spanning a period of 3 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A dynamic allocation technique allocates participants in a 1:1 ratio to one of two treatment arms: Envarsus® tablets (test IMP) or Advagraf® capsules (comparator IMP). Pre-treatment with immediate-release tacrolimus, as well as trial site, are used as stratification factors in the treatment allocation in order to minimise sources of treatment bias.
| Arm | Type | Receives |
|---|---|---|
| Envarsus® | Experimental | Drug: Tacrolimus PillParticipants take prolonged-release tacrolimus tablets orally once daily and additionally receive standard-of-care immunosuppressive background therapy as per routine practice. |
| Advagraf® | Active comparator | Drug: Tacrolimus capsuleParticipants take prolonged-release tacrolimus capsules orally once daily and additionally receive standard-of-care immunosuppressive background therapy as per routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed and dated written informed consent
- Adult (≥18 years old) male or female
- Recipient of a whole liver transplant from a deceased donor or a split liver transplant from a deceased or living donor
- ABO blood type compatible with the organ donor
- Able to swallow an oral formulation of tacrolimus in tablet or capsule form
Key exclusion criteria (16 listed)
- Multi-organ transplantation
- Any previous organ allograft transplantation
- Biopsy-proven acute rejection that is ongoing at the time of randomisation
- Occurrence of post-transplant thrombosis, occlusion or stent placement in any major hepatic arteries, hepatic veins, portal vein or inferior vena cava
- History of extra-hepatic malignancy that could not be curatively treated
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 PillAlso: EnvarsusEnvarsus® tablets dosed to achieve and maintain whole blood trough levels of tacrolimus within a patient-specific therapeutic range (interval of 3 ng/ml) that lies within a wider reference range of 3-12 ng/ml. | Drug | Envarsus® |
| Tacrolimus capsuleAlso: AdvagrafAdvagraf® capsules dosed to achieve and maintain whole blood trough levels of tacrolimus within a patient-specific therapeutic range (interval of 3 ng/ml) that lies within a wider reference range of 3-12 ng/ml. | Drug | Advagraf® |
Primary outcome
Dose-normalised blood trough level of tacrolimus (concentration/dose ratio)
Time frame: 12 weeks post-randomisation
To calculate C/D ratio, "concentration" is the blood trough level of tacrolimus measured in a blood sample collected immediately prior to drug dosing on the day of the 12-week trial visit and "dose" is the daily dose taken by the patient on the day prior to the visit. C/D ratio is measured as a surrogate for tacrolimus bioavailability (i.e. systemic exposure per mg of drug).
35 secondary outcomes
Number of IMP dose adjustments
Time frame: Until 12 weeks post-randomisation
Time to reach the first defined range in target trough level
Time frame: Time period measured in days, assessed at 12 weeks post-randomisation
Number of measurements above and below the first defined range in target trough level
Time frame: Time period measured in days, assessed at 12 weeks post-randomisation
Dose-normalised trough level (C/D ratio) during long-term follow-up
Time frame: 1, 2 and 3 years post-randomisation
Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels
Time frame: 1, 2, 4 and 12 weeks post-randomisation
Inter-patient variability (range) of tacrolimus total daily dose
Time frame: Until 12 weeks post-randomisation
Proportion of patients with trough levels lower, within, or higher than the standard reference range
Time frame: 1, 2, 4 and 12 weeks post-randomisation
Incidence and severity of clinically-confirmed biopsy-proven acute rejection
Time frame: 12 weeks and 1, 2, 3 years post-randomisation
Incidence of graft failure (defined as necessity for re-transplantation)
Time frame: 12 weeks and 1, 2, 3 years post-randomisation
Incidence of death (for any reason)
Time frame: 12 weeks and 1, 2, 3 years post-randomisation
Treatment failure rate (composite endpoint of biopsy-proven acute rejection, graft failure or death)
Time frame: 12 weeks and 1, 2, 3 years post-randomisation
Time to treatment failure (composite endpoint of biopsy-proven acute rejection, graft failure or death) after randomisation
Time frame: 3 years post-randomisation
Incidence of acute rejections requiring treatment
Time frame: 12 weeks post-randomisation
Incidence of multiple rejection episodes
Time frame: 12 weeks post-randomisation
Change versus baseline in laboratory measures of liver function (aspartate transaminase, alanine transaminase, alkaline phosphatase, gamma-glutamyltransferase, bilirubin, albumin, cholinesterase, INR)
Time frame: 12 weeks and 1, 2, 3 years post-randomisation
Change versus baseline in laboratory measures of metabolic profile (triglycerides, HDL cholesterol, LDL cholesterol, total cholesterol, HbA1c, fasting plasma glucose)
Time frame: 12 weeks and 1, 2, 3 years post-randomisation
Change versus baseline in laboratory measures of renal function (creatinine, estimated glomerular filtration rate)
Time frame: 12 weeks and 1, 2, 3 years post-randomisation
Incidence and type of malignancies diagnosed in trial participants
Time frame: 1, 2 and 3 years post-randomisation
Incidence and type of infections (hepatitis C virus, hepatitis B virus, cytomegalovirus, Epstein-Barr virus) experienced by trial participants
Time frame: 1, 2 and 3 years post-randomisation
Degree of liver fibrosis (fibroscan or biopsy)
Time frame: 12 weeks and 1, 2, 3 years post-randomisation
Incidence, type, severity, seriousness and causality of adverse events (AEs)
Time frame: 3 years post-randomisation
Change versus baseline in heart rate
Time frame: 3 years post-randomisation
Change versus baseline in blood pressure
Time frame: 3 years post-randomisation
Change versus baseline in body weight
Time frame: 3 years post-randomisation
Incidence of de novo occurrence of tremor or vision impairments
Time frame: 3 years post-randomisation
Incidence of post-transplant diabetes mellitus and post-transplant hyperglycaemia
Time frame: 12 weeks and 1, 2, 3 years post-randomisation
Dose-normalised trough level (C/D ratio)
Time frame: 12 weeks post-transplantation
Number and doses of immunosuppressive medications (incl. other tacrolimus formulations)
Time frame: At 12 weeks and after 12 weeks (if applicable)
Recurrence of primary hepatic disease
Time frame: 3 years post-randomisation
Incidence of donor-specific antibodies
Time frame: 12 weeks and 1, 2, 3 years post-randomisation
Continuation rate
Time frame: 12 weeks post-randomisation
Incidence and time to study treatment discontinuation
Time frame: 3 years post-randomisation
Incidence of patient withdrawal from the study
Time frame: 3 years post-randomisation
Time to patient withdrawal from the study
Time frame: 3 years post-randomisation
Reason for patient withdrawal from the study
Time frame: 3 years post-randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 37170284Wohl DS, James B, Gotz M, Brennfleck F, Holub-Hayles I, Mutzbauer I, Baccar S, Brunner SM, Geissler EK, Schlitt HJ; EnGraft Trial Group. EnGraft: a multicentre, open-label, randomised, two-arm, superiority study protocol to assess bioavailability and practicability of Envarsus(R) versus Advagraf in liver transplant recipients. Trials. 2023 May 11;24(1):325. doi: 10.1186/s13063-023-07344-7.
- Individual participant dataSharing planned: No
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.
Hans J. Schlitt, MD principal investigator
University Hospital Regensburg
15 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 Pill and Tacrolimus capsule in people with Prophylaxis Against Liver Transplant Rejection, run by Edward Geissler at 15 sites in Germany.
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 5 inclusion and 16 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose-normalised blood trough level of tacrolimus (concentration/dose ratio) (time frame: 12 weeks post-randomisation). 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 NCT04720326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.