Kidney TransplantationPhase 4NCT01895049
Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria
A Phase 4 study testing Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus and Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus in people with Kidney Transplantation and Cytomegalovirus, run by Helio Tedesco Silva Junior at 1 site in Brazil.
Trial summary
The disparity between supply and demand for organs has stimulated the development of strategies to increase the availability of kidney grafts. Such strategy involves the use of kidneys with expanded donor criteria (EDC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Cytomegalovirus
- What is being tested?
- Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus and Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to 7 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (> 18 years) candidates to renal transplant with expanded criteria deceased donors;
- Low risk of acute rejection, defined as first kidney transplant recipients and Panel Reactive Antibody (PRA) <50%.
- Signature of the informed consent form (ICF)
Who cannot join
- Patients receiving immunosuppressive therapy before transplantation;
- Patients who have received an investigational drug within last 30 days;
- Patients with a known contraindication to the administration of an anti-thymocyte globulin;
- Patients with a positive test for human immunodeficiency virus (HIV);
- Patients who had cancer (except non-melanoma skin cancer) within last two years;
- Pregnant women, breastfeeding women, and women of childbearing potential unwilling to use condoms or oral contraceptives will be excluded;
- Patients with any Panel Reactive Antibody (PRA) equal to or higher than 50%, class I or class II, will also be excluded;
- Patients with positive test for parasites (protozoa and helminths).
Trial locations and contacts
1 site in 1 country.
About this study
The disparity between supply and demand for organs has stimulated the development of strategies to increase the availability of kidney grafts. Such strategy involves the use of kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator, open, prospective, randomized, single center designed to compare the safety and efficacy of two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor criteria expanded.
- Conditions
- Kidney Transplantation, Cytomegalovirus
- Being tested
- Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus, Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus
- Keywords
- Tacrolimus, Everolimus, Cytomegalovirus, Thymoglobulin, Deceased donors, Expanded criteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimusDrug
Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate sodium | Active comparator | Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium, and late introduction of tacrolimus Receives: Drug: Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus |
| Everolimus | Experimental | Induction therapy with Thymoglobulin, prednisone, everolimus, and late introduction of tacrolimus. Receives: Drug: Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CMV disease
Incidence of CMV disease or infection during the first year of transplantation.
Measured: 1 year
Secondary outcomes (1)
incidence of treatment failure
To compare the two immunosuppressive regimens for the incidence of treatment failure defined as the composite endpoint of BPAR (biopsy-proven acute rejection), graft loss, death and loss to follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completion7 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helio Tedesco Silva Junior
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis, Sanofi
- Responsible party
- Sponsor-investigator, Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895049
- Sponsor's protocol ID
- CRAD001ABR32T
- Status last verified
- Aug 2017
- First submitted
- 1 Jul 2013
- Last updated
- 15 Aug 2017
- Results posted
- No
Publications
Oliveras L, Lopez-Vargas P, Melilli E, Codina S, Royuela A, Coloma Lopez A, Fava A, Manonelles A, Couceiro C, Lloberas N, Cruzado JM, Montero N. Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function. Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014855. doi: 10.1002/14651858.CD014855.pub2.
PubMed 40197799Ferreira AN, Felipe CR, Cristelli M, Viana L, Mansur J, de Paula M, Wagner D, de Marco R, Gerbase-DeLima M, Proenca H, Aguiar W, Medina-Pestana J, Tedesco-Silva Junior H. Prospective randomized study comparing everolimus and mycophenolate sodium in de novo kidney transplant recipients from expanded criteria deceased donor. Transpl Int. 2019 Nov;32(11):1127-1143. doi: 10.1111/tri.13478. Epub 2019 Aug 27.
PubMed 31278785
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria
- ClinicalTrials.gov ID
- NCT01895049
- Acronym / sponsor ID
- CRAD001ABR32T
- Conditions
- Kidney Transplantation, Cytomegalovirus
- Keywords
- Tacrolimus, Everolimus, Cytomegalovirus, Thymoglobulin, Deceased donors, Expanded criteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Helio Tedesco Silva JuniorUniversity, hospital or other
- Collaborators
- Novartis, Sanofi
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- 7 Mar 2017 (actual)
- First posted
- 10 Jul 2013 (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.
The disparity between supply and demand for organs has stimulated the development of strategies to increase the availability of kidney grafts. Such strategy involves the use of kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator, open, prospective, randomized, single center designed to compare the safety and efficacy of two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor criteria expanded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate sodium | Active comparator | Drug: Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimusInduction therapy with Thymoglobulin, prednisone, mycophenolate sodium, and late introduction of tacrolimus |
| Everolimus | Experimental | Drug: Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimusInduction therapy with Thymoglobulin, prednisone, everolimus, and late introduction of tacrolimus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (> 18 years) candidates to renal transplant with expanded criteria deceased donors;
- Low risk of acute rejection, defined as first kidney transplant recipients and Panel Reactive Antibody (PRA) <50%.
- Signature of the informed consent form (ICF)
Key exclusion criteria (8 listed)
- Patients receiving immunosuppressive therapy before transplantation;
- Patients who have received an investigational drug within last 30 days;
- Patients with a known contraindication to the administration of an anti-thymocyte globulin;
- Patients with a positive test for human immunodeficiency virus (HIV);
- Patients who had cancer (except non-melanoma skin cancer) within last two years;
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 |
|---|---|---|
| Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus | Drug | Everolimus |
| Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus | Drug | Mycophenolate sodium |
Primary outcome
Incidence of CMV disease
Time frame: 1 year
Incidence of CMV disease or infection during the first year of transplantation.
1 secondary outcome
incidence of treatment failure
Time frame: 1 year
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 15 Aug 2017.
- Derived from this study: PubMed 40197799Oliveras L, Lopez-Vargas P, Melilli E, Codina S, Royuela A, Coloma Lopez A, Fava A, Manonelles A, Couceiro C, Lloberas N, Cruzado JM, Montero N. Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function. Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014855. doi: 10.1002/14651858.CD014855.pub2.
- Derived from this study: PubMed 31278785Ferreira AN, Felipe CR, Cristelli M, Viana L, Mansur J, de Paula M, Wagner D, de Marco R, Gerbase-DeLima M, Proenca H, Aguiar W, Medina-Pestana J, Tedesco-Silva Junior H. Prospective randomized study comparing everolimus and mycophenolate sodium in de novo kidney transplant recipients from expanded criteria deceased donor. Transpl Int. 2019 Nov;32(11):1127-1143. doi: 10.1111/tri.13478. Epub 2019 Aug 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus and Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus in people with Kidney Transplantation and Cytomegalovirus, run by Helio Tedesco Silva Junior 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 8 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 15 Aug 2017. 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 CMV disease (time frame: 1 year). 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 NCT01895049, which also lists 2 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 15 Aug 2017.