Liver TransplantationPhase 3NCT01888432
Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants
A Phase 3 study testing Everolimus + reduced tacrolimus and Standard tacrolimus in people with Liver Transplantation, run by Novartis Pharmaceuticals at 42 sites in 13 countries.
Trial summary
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Everolimus + reduced tacrolimus and Standard tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 42 sitesin 13 countries
- Study dates
- 25 Sep 2013to 21 Apr 2018
- Phase
- Phase 3
- 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
- Written informed consent
- Subject aged ≥18 years of a primary, orthotopic liver allograft, from a living donor
- Subject negative for HIV
- Incusion criteria at Randomization:
- Subject was initated on tacrolimus-based immunosuppressive regimen with steroids and other immunosuppression
- Written informed consent must be obtained before any extension specific assessment is performed.
- Ability and willingness to adhere to study regimen.
- Completed Month 24 visit of core study and continuously being treated with assigned regimen.
Who cannot join
- Subjects transplanted for acute liver failure
- HCV negativesubjects receiving a transplant from HCV positive donor
- Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant.
- Subjects receiving an ABO incompatible allograft.
- MELD-score > 35 within 1 month prior to transplantation.
- Use of immunosuppressive or antibody induction agents not specified in the protocol.
Show all 29Show fewer
- History of malignancy of any organ system (except hepatocellular carcinoma or localized basal cell carcinoma of the skin)
- Hepatocellular carcinoma with extrahepatic spread or macrovascular invasion
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 2 weeks after the last dose of study medication
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients
- Any post-transplant history of thrombosis, occlusion or stent placement in any major hepatic arteries, hepatic veins, portal vein or inferior vena cava at any time during the run-in period prior to randomization.
- Subjects with a confirmed spot urine protein/creatinine ratio that indicates ≥ 1.0 g/24 hrs of proteinuria
- Subjects who have severe hypercholesterolemia (>350 mg/dL; >9.1 mmol/L) or hypertriglyceridemia (>500 mg/dL; >5.6 mmol/L) at randomization.
- Subjects with platelet count < 30,000/mm3.
- Subjects with an absolute neutrophil count of < 1,000/mm³ or white blood cell count of < 2,000/mm³.
- Subjects with systemic infection requiring active use of IV antibiotics.
- Subjects requiring life support measures such as ventilation, dialysis, vasopressor agents.
- Subjects who require renal replacement therapy within 7 days prior to randomization.
- Subjects with detectable HBV DNA at time of randomization
- Subjects meeting the following criteria for acute rejection during the run in period:
- Any acute rejection in the week prior to randomization.
- 2 treated acute rejections.
- Any rejection requiring antibody treatment.
- Any severe cellular (and/or any humoral) rejection.
- Long term extension for patients in Japan:
- Use of medication that is prohibited by the study protocol at Month 24.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- History of hypersensitivity to any of the study drugs or to drugs with similar chemical class, or to any of the excipients
Trial locations and contacts
42 sites in 13 countries.
42 sites in 13 countries
United States9 sites
Novartis Investigative Site
Baltimore, Maryland, 21201
Novartis Investigative Site
Boston, Massachusetts, 02114
Novartis Investigative Site
Burlington, Massachusetts, 01805
Novartis Investigative Site
Charlottesville, Virginia, 22908
Novartis Investigative Site
Detroit, Michigan, 48202
Novartis Investigative Site
Los Angeles, California, 90033
Novartis Investigative Site
Minneapolis, Minnesota, 55455
Novartis Investigative Site
New York, New York, 10032
Novartis Investigative Site
San Francisco, California, 94143
Japan9 sites
Novartis Investigative Site
Bunkyo Ku, Tokyo, 113 8655
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582
Novartis Investigative Site
Hiroshima, Hiroshima, 734-8551
Novartis Investigative Site
Kumamoto, Kumamoto, 860-8556
Novartis Investigative Site
Nagasaki, Nagasaki, 852-8501
Novartis Investigative Site
Nagoya, Aichi-ken, 466 8560
Novartis Investigative Site
Okayama, Okayama-ken, 700-8558
Novartis Investigative Site
Sakyo Ku, Kyoto, 606 8507
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-8582
Germany4 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Jena, 07740
Novartis Investigative Site
Kiel, 24105
Novartis Investigative Site
Regensburg, Bavaria, 93053
India4 sites
Novartis Investigative Site
Chennai, Tamil Nadu, 600006
Novartis Investigative Site
Chennai, Tamil Nadu, 600100
Novartis Investigative Site
Gurgaon, Haryana, 122 001
Novartis Investigative Site
Kochi, Kerala, 682 026
South Korea4 sites
Novartis Investigative Site
Seoul, Gyeonggi-do, 03080
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, 03722
Taiwan4 sites
Novartis Investigative Site
Kaohsiung City, 83301
Novartis Investigative Site
Taichung, 40447
Novartis Investigative Site
Taipei, 11217
Novartis Investigative Site
Taoyuan, 33305
Turkey (Türkiye)2 sites
Novartis Investigative Site
Malatya, 44280
Novartis Investigative Site
Mecidiyekoy/Istanbul, 34394
About this study
Official title: A 24 Month, Randomized, Controlled, Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants and Long Term Extension to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants in Japan
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
Read the detailed description
This study was 24 month, multicenter study in 280 living donor liver transplant patients from Asia, Europe and Canada. The study has an long term extension in Japan and approximately 28 patients were to be included to evaluate the long-term efficacy and safety of concentration-controlled everolimus regimen plus reduced tacrolimus compared to standard tacrolimus in recipients of living donor liver transplants in Japan who participated in the CRAD001H2307 study.
Data reported here are the CRAD001H2307 core study results and its extension (CRAD001H2307E1).
- Conditions
- Liver Transplantation
- Being tested
- Everolimus + reduced tacrolimus, Standard tacrolimus
- Keywords
- liver transplantation, everolimus, tacrolimus, reduced calcineuron inhibitor, renal function, living donor, RAD001H2307, RAD001H
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus + reduced tacrolimusDrug
Everolimus was initiated at Week 4 post transplantation. The dose was adjusted to maintain the everolimus trough blood levels between 3-8 ng/mL for the duration of the study. Tacrolimus was reduced to 3-5 ng/mL.
Standard tacrolimusDrug
Tacrolimus was initiated as soon as possible after transplantation according to approved labeling recommendations. The trough level should've been 5-15 ng/mL until randomization, 8-12 ng/mL from randomization until month 4 and after month 4 until end of study reduced to 6 -10 ng/mL.
| Study group | Role | What they receive |
|---|---|---|
| Everolimus + reduced tacrolimus | Experimental | Everolimus + reduced tacrolimus ± corticosteroids Receives: Drug: Everolimus + reduced tacrolimus |
| Standard tacrolimus | Active comparator | Standard tacrolimus ± corticosteroids Receives: Drug: Standard tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Composite Efficacy Failure of Treated Biopsy Proven Acute Rejection, Graft Loss or Death in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus
Rate of composite efficacy failure of treated biopsy proven acute rejection (tBPAR ≥ RAI score 3), graft loss (GL) or death (D) in everolimus with reduced tacrolimus group compared to standard tacrolimus at 12 months
Measured: 12 months post transplantation
Secondary outcomes (15)
Renal Function by Estimated Glomerular Filtration Rate (eGFR) From Randomization
Renal function (change in estimated glomerular filtration rate (eGFR)) from randomization to Month 12 post transplantation with everolimus (EVR) in combination with reduced tacrolimus (rTAC) compared to standard exposure tacrolimus (TAC) in living donor liver transplant recipients.
Measured: From randomization to month 12
Compare Renal Function Over Time Assessed by the Change by eGFR, Post-randomization
Change in renal function from randomization to month 24 assessed by the change in estimated GFR (MDRD-4). Rate of change of renal function.
Measured: From randomziation to month 24
Number of Participants With Composite of tBPAR, Graft Loss, and Death
Compare between the treatment group EVR with rTAC vs standard TAC: incidence of a composite of tBPAR, graft loss, death
Measured: Month 24 post transplantation
Compare Incidence of tBPAR
Compare between the treatment group EVR with rTAC vs standard TAC: Incidence of tBPAR
Measured: Month 12 and Month 24 post transplantation
Compare Incidence of BPAR
Compare between the treatment group EVR with rTAC vs standard TAC: incidence of a composite of biopsy proven acute rejection (BPAR)
Measured: Month 12 and Month 24 post transplantation
Compare Incidence of Graft Loss
Compare between the treatment group EVR with rTAC vs standard TAC: incidence of graft loss
Measured: Month 12 and Month 24 post transplantation
Compare Incidence of a Composite of Death or Graft Loss
Compare between the treatment group EVR with rTAC vs standard TAC: Incidence of a composite of death or graft loss
Measured: Month 12 and Month 24 post transplantation
Compare Incidence of Death
Compare between the treatment group EVR with rTAC vs standard TAC: incidence of death
Measured: Month 12 and Month 24 post transplantation
Compare Incidence of AR
Compare between the treatment group EVR with rTAC vs standard TAC: incidence of acute rejection (AR)
Measured: Month 12 and Month 24 post transplantation
Compare Incidence of tAR
Compare between the treatment group EVR with rTAC vs standard TAC: incidence of treated acute rejection (tAR).
Measured: Month 12 and Month 24 post transplantation
Number of Participants With Time to Recurrence of HCC in Subjects With a Diagnosis of HCC at the Time of Liver Transplantation
Patients transplanted for HCC or with HCC diagnosed at time of transplantation were monitored for HCC recurrence according to local practice. For example routine laboratory monitoring/tests, tumor markers, hepatic ultrasound, computed tomography scans (CAT, CT) or MRI (especially Fe-MRI) on a regular basis per local practice.
Measured: Month 12 and Month 24
Number of Subjects Experiencing Adverse Events/Infections by SOC
Measured: Month 24
Compare Incidence of Notable Safety Events (SAEs, Infections and Serious Infections Leading to Premature Discontinuation)
Notable events include death, Serious AE/infection,, and AE/infection leading to discontinuation of study medication.
Measured: Month 24
Composite Efficacy Failure of Treated Biopsy in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus in Patients From Japan Only
Rate of composite efficacy failure of treated biopsy in everolimus with reduced tacrolimus group compared to standard tacrolimus from randomization in core study up to 36 months in the extension study.
Composite endpoint = treated BPAR, graft loss or death. AR = Acute rejection; tAR = treated AR; BPR = biopsy proven rejection; BPAR = biopsy proven acute rejection; tBPAR = treated BPAR
Measured: randomization, 36 months post transplantion
Renal Function by Estimated Glomerular Filtration Rate (All Extension Patients)
Renal function (change in estimated glomerular filtration rate (eGFR)) from randomization to Month 36 post transplantation with everolimus (EVR) in combination with reduced tacrolimus (rTAC) compared to standard exposure tacrolimus (TAC) in living donor liver transplant recipients in Japan
Measured: randomization, at 36 months post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study start25 Sep 2013
- Primary completion19 Oct 2016
- Study completion21 Apr 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a 24-month, multicenter, open-label, randomized, controlled study. It included the extension to the 24-month, randomized, controlled, open-label CRAD001H2307 study in recipients of living donor liver transplants in Japan.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888432
- Sponsor's protocol ID
- CRAD001H2307
- Other IDs
- 2010-024527-25
- Status last verified
- Feb 2019
- First submitted
- 15 Jun 2013
- Last updated
- 18 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Jeng LB, Lee SG, Soin AS, Lee WC, Suh KS, Joo DJ, Uemoto S, Joh J, Yoshizumi T, Yang HR, Song GW, Lopez P, Kochuparampil J, Sips C, Kaneko S, Levy G. Efficacy and safety of everolimus with reduced tacrolimus in living-donor liver transplant recipients: 12-month results of a randomized multicenter study. Am J Transplant. 2018 Jun;18(6):1435-1446. doi: 10.1111/ajt.14623. Epub 2018 Jan 25.
PubMed 29237235
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Month, Randomized, Controlled, Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants and Long Term Extension to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants in Japan
- ClinicalTrials.gov ID
- NCT01888432
- Acronym / sponsor ID
- CRAD001H2307
- Conditions
- Liver Transplantation
- Keywords
- liver transplantation, everolimus, tacrolimus, reduced calcineuron inhibitor, renal function, living donor, RAD001H2307, RAD001H
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2013 (actual)
- Primary completion
- 19 Oct 2016 (actual)
- Study completion
- 21 Apr 2018 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Posted 13 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.
Detailed description
This study was 24 month, multicenter study in 280 living donor liver transplant patients from Asia, Europe and Canada. The study has an long term extension in Japan and approximately 28 patients were to be included to evaluate the long-term efficacy and safety of concentration-controlled everolimus regimen plus reduced tacrolimus compared to standard tacrolimus in recipients of living donor liver transplants in Japan who participated in the CRAD001H2307 study.
Data reported here are the CRAD001H2307 core study results and its extension (CRAD001H2307E1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This was a 24-month, multicenter, open-label, randomized, controlled study. It included the extension to the 24-month, randomized, controlled, open-label CRAD001H2307 study in recipients of living donor liver transplants in Japan.
| Arm | Type | Receives |
|---|---|---|
| Everolimus + reduced tacrolimus | Experimental | Drug: Everolimus + reduced tacrolimusEverolimus + reduced tacrolimus ± corticosteroids |
| Standard tacrolimus | Active comparator | Drug: Standard tacrolimusStandard tacrolimus ± corticosteroids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent
- Subject aged ≥18 years of a primary, orthotopic liver allograft, from a living donor
- Subject negative for HIV
- Subject was initated on tacrolimus-based immunosuppressive regimen with steroids and other immunosuppression
- Written informed consent must be obtained before any extension specific assessment is performed.
Key exclusion criteria (29 listed)
- Subjects transplanted for acute liver failure
- HCV negativesubjects receiving a transplant from HCV positive donor
- Subjects receiving multiple solid organ (including multiple liver lobes/segments) or islet cell tissue transplants, or have previously received an organ or tissue transplant.
- Subjects receiving an ABO incompatible allograft.
- MELD-score > 35 within 1 month prior to transplantation.
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 |
|---|---|---|
| Everolimus + reduced tacrolimusEverolimus was initiated at Week 4 post transplantation. The dose was adjusted to maintain the everolimus trough blood levels between 3-8 ng/mL for the duration of the study. Tacrolimus was reduced to 3-5 ng/mL. | Drug | Everolimus + reduced tacrolimus |
| Standard tacrolimusTacrolimus was initiated as soon as possible after transplantation according to approved labeling recommendations. The trough level should've been 5-15 ng/mL until randomization, 8-12 ng/mL from randomization until month 4 and after month 4 until end of study reduced to 6 -10 ng/mL. | Drug | Standard tacrolimus |
Primary outcome
Number of Participants With Composite Efficacy Failure of Treated Biopsy Proven Acute Rejection, Graft Loss or Death in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus
Time frame: 12 months post transplantation
Rate of composite efficacy failure of treated biopsy proven acute rejection (tBPAR ≥ RAI score 3), graft loss (GL) or death (D) in everolimus with reduced tacrolimus group compared to standard tacrolimus at 12 months
15 secondary outcomes
Renal Function by Estimated Glomerular Filtration Rate (eGFR) From Randomization
Time frame: From randomization to month 12
Compare Renal Function Over Time Assessed by the Change by eGFR, Post-randomization
Time frame: From randomziation to month 24
Number of Participants With Composite of tBPAR, Graft Loss, and Death
Time frame: Month 24 post transplantation
Compare Incidence of tBPAR
Time frame: Month 12 and Month 24 post transplantation
Compare Incidence of BPAR
Time frame: Month 12 and Month 24 post transplantation
Compare Incidence of Graft Loss
Time frame: Month 12 and Month 24 post transplantation
Compare Incidence of a Composite of Death or Graft Loss
Time frame: Month 12 and Month 24 post transplantation
Compare Incidence of Death
Time frame: Month 12 and Month 24 post transplantation
Compare Incidence of AR
Time frame: Month 12 and Month 24 post transplantation
Compare Incidence of tAR
Time frame: Month 12 and Month 24 post transplantation
Number of Participants With Time to Recurrence of HCC in Subjects With a Diagnosis of HCC at the Time of Liver Transplantation
Time frame: Month 12 and Month 24
Number of Subjects Experiencing Adverse Events/Infections by SOC
Time frame: Month 24
Compare Incidence of Notable Safety Events (SAEs, Infections and Serious Infections Leading to Premature Discontinuation)
Time frame: Month 24
Composite Efficacy Failure of Treated Biopsy in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus in Patients From Japan Only
Time frame: randomization, 36 months post transplantion
Renal Function by Estimated Glomerular Filtration Rate (All Extension Patients)
Time frame: randomization, at 36 months post transplantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29237235Jeng LB, Lee SG, Soin AS, Lee WC, Suh KS, Joo DJ, Uemoto S, Joh J, Yoshizumi T, Yang HR, Song GW, Lopez P, Kochuparampil J, Sips C, Kaneko S, Levy G. Efficacy and safety of everolimus with reduced tacrolimus in living-donor liver transplant recipients: 12-month results of a randomized multicenter study. Am J Transplant. 2018 Jun;18(6):1435-1446. doi: 10.1111/ajt.14623. Epub 2018 Jan 25.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
42 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Everolimus + reduced tacrolimus and Standard tacrolimus in people with Liver Transplantation, run by Novartis Pharmaceuticals at 42 sites in 13 countries.
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 8 inclusion and 29 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 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Japan, Germany, India, South Korea and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2018). 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?
Number of Participants With Composite Efficacy Failure of Treated Biopsy Proven Acute Rejection, Graft Loss or Death in Everolimus With Reduced Tacrolimus Group Compared to Standard Tacrolimus (time frame: 12 months post transplantation). 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 NCT01888432, 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 18 Mar 2019.