Transplantation InfectionPhase 4NCT02084446
Everolimus + Very Low Tacrolimus vs Enteric-coated Mycophenolate Sodium + Low Tacrolimus in de Novo Renal Transplant
A Phase 4 study testing Everolimus, Very Low Tacrolimus and Low Tacrolimus in people with Transplantation Infection and Cytomegalovirus Infections, run by Ronaldo de Matos Esmeraldo, MD at 1 site in Brazil.
Trial summary
This is a 12-month single center, randomized, open-label, single center study designed to compare the safety and efficacy of everolimus and very low dose tacrolimus versus enteric-coated sodium mycophenolate and low tacrolimus exposure in de novo kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transplantation Infection, Cytomegalovirus Infections
- What is being tested?
- Everolimus, Very Low Tacrolimus and Low Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2012to Jul 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female renal recipients 18-75 years of age undergoing kidney transplantation, from a primary deceased donor (including expanded criteria donor organs), living unrelated or non-HLA identical living related donor kidney;
- Recipient of a kidney with a cold ischemia time < 30 hours;
- Graft must be functional (producing greater than or equal to 300 ml of urine within 24 hours after transplantation) at time of randomization.
Who cannot join
- Donor organ with a cold ischemic time > 30 hours;
- Patients who produce less than 300 ml of urine in the first 24 hours post-transplantation;
- Patients who are recipients of multiple organ transplants;
- Patients who are recipients of ABO incompatible transplants, or T or B cell cross match positive transplant;
- Patients with current Panel Reactive Antibodies (PRA) level ≥ 50%;
- Patients with severe hypercholesterolemia (350 mg/dl) or hypertriglyceridemia (500 mg/dl). Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable;
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- HIV positive patients;
- Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception;
- Decisional impaired subjects who are not medically or mentally capable of providing consent themselves.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Everolimus in Association With Very Low-dose Tacrolimus Versus Enteric-coated Mycophenolate Sodium With Low-dose Tacrolimus in de Novo Renal Transplant Recipients - A Prospective Single Center Study
This is a 12-month single center, randomized, open-label, single center study designed to compare the safety and efficacy of everolimus and very low dose tacrolimus versus enteric-coated sodium mycophenolate and low tacrolimus exposure in de novo kidney transplant recipients.
The purpose of this study is to compare safety and efficacy of two immunosuppressive regimens based on low tacrolimus exposure combined to everolimus or to enteric-coated mycophenolate sodium (EC-MPS) in de novo kidney transplant recipients.
Read the detailed description
The study will consist of two periods: an initial period of 3 months during which all patients in both groups will be monitored in accordance with the same variation of C-0h tacrolimus and a second study period of 9 months (from month 4 to month 12) in which patients will be monitored according to two different targets of C-0h tacrolimus.
At the screening visit and before any assessment related to the study, patients must give their informed consent in writing.
All patients will receive induction with rabbit Thymoglobulin (r-ATG) in four doses of 1.5 mg/kg (maximum total dose of 6 mg/kg), administered according to center local practice.
The evaluations of baseline visit occur within 24 hours after transplantation and prior to the first dose of study drug.
Randomization will be performed within 24 hours after transplantation and after the baseline visit assessments. Patients will be randomized in a 1:1 ratio to one of two groups (everolimus with very low dose of tacrolimus versus sodium mycophenolate with low dose of tacrolimus).
Approximately 120 patients who meet the inclusion criteria will receive their first dose everolimus (initial dose of 1 mg twice a day) or sodium mycophenolate (initial dose of 720 mg twice a day) not more than 24 hours after transplantation. Everolimus trough blood levels will be measured at pre-specified timepoints in order to ensure that trough levels are above 3 ng/ml and below 8 ng/ml for the duration of the study.
Tacrolimus will be started within 48 hours after graft reperfusion at an initial dose of 0.1 mg/kg/day. The dose of tacrolimus will be adjusted to target the C-0h value within the pre-established desired range.
In the everolimus group with very low dose of tacrolimus, tacrolimus dose should be reduced at the end of months three after transplantation. Patients with either acute rejection grade ≥ Banff IIB or more than one treated acute rejection since entering the study and patients with either acute rejection during the third month will not have the dose of tacrolimus reduced; however, they will be encouraged to remain in the study. These patients will be excluded from the per protocol population analysis, but will be analyzed in the Intention To Treat population.
If patients present delayed graft function (DGF), the start of tacrolimus can be postponed for up to and including 7 days.
During the 12 months treatment period, patient visits will occur at the selection visit, baseline visit, at 1, 2, 4 and 8 weeks and at 3, 6 and 12 months. Day 1 is the day of the first administration of everolimus or sodium mycophenolate.
Population: Study population will consist of a group of male or female transplant recipients 18-75 years of age undergoing primary renal transplantation and who received an organ from a living or deceased donor.
- Being tested
- Everolimus, Very Low Tacrolimus, Low Tacrolimus, Steroids, Thymoglobulin
- Keywords
- Everolimus, Tacrolimus, Sodium Mycophenolate, CMV, Graft function, Acute rejection
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Certican, Zortress
Everolimus: initial dose of 1 mg twice a day starting at Day 1. Dose will be adjusted to keep everolimus trough levels between 3 and 8 ng/mL.
Very Low TacrolimusDrug
Also called Very low Prograf
Tacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL during the first 3 months and 2 and 4 ng/mL thereafter.
Low TacrolimusDrug
Also called Low Prograf
Tacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL.
SteroidsDrug
Also called Prednisone, Methylprednisolone
Corticoids: endovenous Methylprednisolone will be administered 30-60 minutes before the first 3 doses of r-ATG: 250 mg (D0) and 125 mg (D2 and D4); Prednisone, 10 mg per oral, will be administered before the last dose of r-ATG (D6). Maintenance with Prednisone at post-transplant period will be performed in accordance with center local practice, i.e., only in patients with chronic previous use of corticosteroids, as well as in patients with autoimmune disease (systemic lupus erythematous, rheumatoid arthritis, etc).
ThymoglobulinDrug
Also called ATG, rabbit Thymoglobulin (r-ATG)
All patients will receive induction with rabbit Thymoglobulin (r-ATG) in four doses of 1.5 mg/kg (maximum total dose of 6 mg/kg), administered according to center local practice (before graft revascularization and at days 2, 4, and 6 post-transplant).
Sodium MycophenolateDrug
Also called Myfortic
Sodium Mycophenolate: initial dose of 720 mg twice a day starting at Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate + Low Tacrolimus | Active comparator | Sodium Mycophenolate: initial dose of 720 mg twice a day starting at Day 1. Tacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL.
Steroids: endovenous Methylprednisolone before doses of r-ATG; Prednisone per oral.
Thymoglobulin: all patients will receive induction in four doses of 1.5 mg/kg (maximum total dose of 6 mg/kg). Receives: Drug: Low Tacrolimus; Drug: Steroids; Drug: Thymoglobulin; Drug: Sodium Mycophenolate |
| Everolimus + Very Low Tacrolimus | Experimental | Everolimus: initial dose of 1 mg twice a day starting at Day 1. Dose will be adjusted to keep everolimus trough levels between 3 and 8 ng/mL.
Tacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL during the first 3 months and 2 and 4 ng/mL thereafter.
Corticoids: endovenous Methylprednisolone before doses of r-ATG; Prednisone per oral.
Thymoglobulin: all patients will receive induction in four doses of 1.5 mg/kg (maximum total dose of 6 mg/kg). Receives: Drug: Everolimus; Drug: Very Low Tacrolimus; Drug: Steroids; Drug: Thymoglobulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cytomegalovirus (CMV) infection (viremia) or disease (syndrome or invasive disease) during the first year of transplantation
Blood (for CMV detection) samples will be evaluated by PCR for the detection of viral infections
Measured: Month 12
Secondary outcomes (5)
Composite efficacy failure rates demonstrated by treated biopsy proven acute rejection episodes (BPAR), graft loss, death, loss to follow-up at months 6 and 12
Acute Rejection Treated acute rejection is defined as a clinically suspected acute rejection, biopsy-proven or not, who was treated and confirmed by the investigator according to treatment response.
Treated biopsy proven acute rejection BPAR is defined as a clinically suspected acute rejection confirmed by biopsy. A biopsy proven acute rejection is defined as a biopsy classified as grade IA, IB, IIA, IIB, or III.
Graft Loss The graft loss is considered from the day when the patient begins dialysis and is not possible to remove he/she from subsequent dialysis. If the patient undergoes a graft nephrectomy, then the day of nephrectomy is the day of graft loss.
Measured: Weeks 1 and 2, Months 1, 2, 3, 6 and 12
• Graft function measured as calculated creatinine clearance according to the Cockcroft and Gault formula at 6 and 12 months after transplantation
Graft function will be evaluated by serum creatinine and creatinine clearance calculated by Cockcroft \& Gault formula. Quantitative proteinuria will also be evaluated.
Measured: Weeks 1 and 2, and Months 1, 2, 3, 6 and 12
Incidence of proteinuria
Proteinuria will be evaluated in urine samples.
Measured: Day 28 and months 3, 6, 9, and 12 after transplantation
Safety Secondary Objectives - incidence of bone marrow suppression, gastrointestinal events, BKV infection, new onset diabetes mellitus; malignancies, dyslipidemia.
Bone marrow suppression will be evaluated by blood cells count. Gastrointestinal events will be evaluated by patient symptoms report and investigator evaluation.
Blood samples will be evaluated by PCR for the detection of BKV infections. Incidence of new onset diabetes mellitus (NODM) will be assessed by the occurrence of patients who are receiving glucose lowering treatment for more than 30 days post-transplant or with a randomized fasting plasma glucose level ≥ 200 mg/dL with two FPG levels ≥ 126 mg/dL or with a 2 hours plasma glucose OGTT ≥ 200 mg/dL post-transplant.
Malignancies will be assessed by investigator during patient visits. Dyslipidemia will be assessed by cholesterol levels > 350 mg/dL or triglycerides levels > 500 mg/dL.
Measured: Week 2 and Months 1, 2, 3, 6 and 12
Incidence of cytomegalovirus (CMV) infection (viremia) or disease (syndrome or invasive disease) during the first year of transplantation
Blood (for CMV detection) samples will be evaluated by PCR for the detection of viral infections
Measured: Week 2, Months 1, 2, 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startDec 2012
- Primary completionJul 2014
- Study completionJul 2017
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 Transplantation InfectionStudies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ronaldo de Matos Esmeraldo, MD
- Sponsor type
- Other government
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor-investigator, Ronaldo de Matos Esmeraldo, MD, Hospital Geral de Fortaleza
- Investigators
- Ronaldo M Esmeraldo, MD, Principal investigator, Hospital Geral de Fortaleza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084446
- Sponsor's protocol ID
- CRAD001ABR25T
- Status last verified
- Feb 2019
- First submitted
- 7 Dec 2012
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
de Sandes-Freitas TV, Pinheiro PMA, Sales MLMBO, Girao CM, Campos EF, Esmeraldo RM. The impact of everolimus in reducing cytomegalovirus events in kidney transplant recipients on steroid-avoidance strategy: 3-year follow-up of a randomized clinical trial. Transpl Int. 2018 Dec;31(12):1345-1356. doi: 10.1111/tri.13313. Epub 2018 Jul 31.
PubMed 29969826
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everolimus in Association With Very Low-dose Tacrolimus Versus Enteric-coated Mycophenolate Sodium With Low-dose Tacrolimus in de Novo Renal Transplant Recipients - A Prospective Single Center Study
- ClinicalTrials.gov ID
- NCT02084446
- Acronym / sponsor ID
- CRAD001ABR25T
- Keywords
- Everolimus, Tacrolimus, Sodium Mycophenolate, CMV, Graft function, Acute rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ronaldo de Matos Esmeraldo, MDOther government
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Dec 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 12-month single center, randomized, open-label, single center study designed to compare the safety and efficacy of everolimus and very low dose tacrolimus versus enteric-coated sodium mycophenolate and low tacrolimus exposure in de novo kidney transplant recipients.
The purpose of this study is to compare safety and efficacy of two immunosuppressive regimens based on low tacrolimus exposure combined to everolimus or to enteric-coated mycophenolate sodium (EC-MPS) in de novo kidney transplant recipients.
Detailed description
The study will consist of two periods: an initial period of 3 months during which all patients in both groups will be monitored in accordance with the same variation of C-0h tacrolimus and a second study period of 9 months (from month 4 to month 12) in which patients will be monitored according to two different targets of C-0h tacrolimus.
At the screening visit and before any assessment related to the study, patients must give their informed consent in writing.
All patients will receive induction with rabbit Thymoglobulin (r-ATG) in four doses of 1.5 mg/kg (maximum total dose of 6 mg/kg), administered according to center local practice.
The evaluations of baseline visit occur within 24 hours after transplantation and prior to the first dose of study drug.
Randomization will be performed within 24 hours after transplantation and after the baseline visit assessments. Patients will be randomized in a 1:1 ratio to one of two groups (everolimus with very low dose of tacrolimus versus sodium mycophenolate with low dose of tacrolimus).
Approximately 120 patients who meet the inclusion criteria will receive their first dose everolimus (initial dose of 1 mg twice a day) or sodium mycophenolate (initial dose of 720 mg twice a day) not more than 24 hours after transplantation. Everolimus trough blood levels will be measured at pre-specified timepoints in order to ensure that trough levels are above 3 ng/ml and below 8 ng/ml for the duration of the study.
Tacrolimus will be started within 48 hours after graft reperfusion at an initial dose of 0.1 mg/kg/day. The dose of tacrolimus will be adjusted to target the C-0h value within the pre-established desired range.
In the everolimus group with very low dose of tacrolimus, tacrolimus dose should be reduced at the end of months three after transplantation. Patients with either acute rejection grade ≥ Banff IIB or more than one treated acute rejection since entering the study and patients with either acute rejection during the third month will not have the dose of tacrolimus reduced; however, they will be encouraged to remain in the study. These patients will be excluded from the per protocol population analysis, but will be analyzed in the Intention To Treat population.
If patients present delayed graft function (DGF), the start of tacrolimus can be postponed for up to and including 7 days.
During the 12 months treatment period, patient visits will occur at the selection visit, baseline visit, at 1, 2, 4 and 8 weeks and at 3, 6 and 12 months. Day 1 is the day of the first administration of everolimus or sodium mycophenolate.
Population: Study population will consist of a group of male or female transplant recipients 18-75 years of age undergoing primary renal transplantation and who received an organ from a living or deceased donor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate + Low Tacrolimus | Active comparator | Drug: Low Tacrolimus, Drug: Steroids, Drug: Thymoglobulin, Drug: Sodium MycophenolateSodium Mycophenolate: initial dose of 720 mg twice a day starting at Day 1. Tacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL. Steroids: endovenous Methylprednisolone before doses of r-ATG; Prednisone per oral. Thymoglobulin: all patients will receive induction in four doses of 1.5 mg/kg (maximum total dose of 6 mg/kg). |
| Everolimus + Very Low Tacrolimus | Experimental | Drug: Everolimus, Drug: Very Low Tacrolimus, Drug: Steroids, Drug: ThymoglobulinEverolimus: initial dose of 1 mg twice a day starting at Day 1. Dose will be adjusted to keep everolimus trough levels between 3 and 8 ng/mL. Tacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL during the first 3 months and 2 and 4 ng/mL thereafter. Corticoids: endovenous Methylprednisolone before doses of r-ATG; Prednisone per oral. Thymoglobulin: all patients will receive induction in four doses of 1.5 mg/kg (maximum total dose of 6 mg/kg). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female renal recipients 18-75 years of age undergoing kidney transplantation, from a primary deceased donor (including expanded criteria donor organs), living unrelated or non-HLA identical living related donor kidney;
- Recipient of a kidney with a cold ischemia time < 30 hours;
- Graft must be functional (producing greater than or equal to 300 ml of urine within 24 hours after transplantation) at time of randomization.
Key exclusion criteria (9 listed)
- Donor organ with a cold ischemic time > 30 hours;
- Patients who produce less than 300 ml of urine in the first 24 hours post-transplantation;
- Patients who are recipients of multiple organ transplants;
- Patients who are recipients of ABO incompatible transplants, or T or B cell cross match positive transplant;
- Patients with current Panel Reactive Antibodies (PRA) level ≥ 50%;
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 |
|---|---|---|
| EverolimusAlso: Certican, ZortressEverolimus: initial dose of 1 mg twice a day starting at Day 1. Dose will be adjusted to keep everolimus trough levels between 3 and 8 ng/mL. | Drug | Everolimus + Very Low Tacrolimus |
| Very Low TacrolimusAlso: Very low PrografTacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL during the first 3 months and 2 and 4 ng/mL thereafter. | Drug | Everolimus + Very Low Tacrolimus |
| Low TacrolimusAlso: Low PrografTacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL. | Drug | Mycophenolate + Low Tacrolimus |
| SteroidsAlso: Prednisone, MethylprednisoloneCorticoids: endovenous Methylprednisolone will be administered 30-60 minutes before the first 3 doses of r-ATG: 250 mg (D0) and 125 mg (D2 and D4); Prednisone, 10 mg per oral, will be administered before the last dose of r-ATG (D6). Maintenance with Prednisone at post-transplant period will be performed in accordance with center local practice, i.e., only in patients with chronic previous use of corticosteroids, as well as in patients with autoimmune disease (systemic lupus erythematous, rheumatoid arthritis, etc). | Drug | Everolimus + Very Low Tacrolimus, Mycophenolate + Low Tacrolimus |
| ThymoglobulinAlso: ATG, rabbit Thymoglobulin (r-ATG)All patients will receive induction with rabbit Thymoglobulin (r-ATG) in four doses of 1.5 mg/kg (maximum total dose of 6 mg/kg), administered according to center local practice (before graft revascularization and at days 2, 4, and 6 post-transplant). | Drug | Everolimus + Very Low Tacrolimus, Mycophenolate + Low Tacrolimus |
| Sodium MycophenolateAlso: MyforticSodium Mycophenolate: initial dose of 720 mg twice a day starting at Day 1. | Drug | Mycophenolate + Low Tacrolimus |
Primary outcome
Incidence of cytomegalovirus (CMV) infection (viremia) or disease (syndrome or invasive disease) during the first year of transplantation
Time frame: Month 12
Blood (for CMV detection) samples will be evaluated by PCR for the detection of viral infections
5 secondary outcomes
Composite efficacy failure rates demonstrated by treated biopsy proven acute rejection episodes (BPAR), graft loss, death, loss to follow-up at months 6 and 12
Time frame: Weeks 1 and 2, Months 1, 2, 3, 6 and 12
• Graft function measured as calculated creatinine clearance according to the Cockcroft and Gault formula at 6 and 12 months after transplantation
Time frame: Weeks 1 and 2, and Months 1, 2, 3, 6 and 12
Incidence of proteinuria
Time frame: Day 28 and months 3, 6, 9, and 12 after transplantation
Safety Secondary Objectives - incidence of bone marrow suppression, gastrointestinal events, BKV infection, new onset diabetes mellitus; malignancies, dyslipidemia.
Time frame: Week 2 and Months 1, 2, 3, 6 and 12
Incidence of cytomegalovirus (CMV) infection (viremia) or disease (syndrome or invasive disease) during the first year of transplantation
Time frame: Week 2, Months 1, 2, 3 and 6
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 22 Feb 2019.
- Derived from this study: PubMed 29969826de Sandes-Freitas TV, Pinheiro PMA, Sales MLMBO, Girao CM, Campos EF, Esmeraldo RM. The impact of everolimus in reducing cytomegalovirus events in kidney transplant recipients on steroid-avoidance strategy: 3-year follow-up of a randomized clinical trial. Transpl Int. 2018 Dec;31(12):1345-1356. doi: 10.1111/tri.13313. Epub 2018 Jul 31.
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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.
Ronaldo M Esmeraldo, MD principal investigator
Hospital Geral de Fortaleza
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 Everolimus, Very Low Tacrolimus and Low Tacrolimus in people with Transplantation Infection and Cytomegalovirus Infections, run by Ronaldo de Matos Esmeraldo, MD at 1 site in Brazil.
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: finished, as of the sponsor's last update on 22 Feb 2019. 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 Brazil. 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?
Incidence of cytomegalovirus (CMV) infection (viremia) or disease (syndrome or invasive disease) during the first year of transplantation (time frame: Month 12). 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 NCT02084446, 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 22 Feb 2019.