A Phase 4 interventional study of Sirolimus and Everolimus in Kidney Transplant Infection, sponsored by Hospital do Rim e Hipertensão. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by Hospital do Rim e Hipertensão · Phase 4, Interventional, and Prevention
This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus.
The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant medical need in the absence of pharmacological prophylaxis.
Hospital do Rim e Hipertensão is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive initial dose of 0,05 mg/kg BID oftacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of sirolimus of 3mg once a day to reach blood trough concentration between 4-8 ng/mL.
Drug: Sirolimus
Patients will receive initial dose of 0,05 mg/kg BID de tacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of 1.5 mg BID of everolimus to reach blood trough concentration between 4-8 ng/mL.
Drug: Everolimus
Patients will receive initial dose of 0,1 mg/kg BID de tacrolimusto reach blood trough concentration between Fixed dose of mycophenolate (mycophenolate mofetil, 1 g BID or sodium mycophenolate, 720 mg BID).
Drug: Mycophenolic acid
sirolimus combined to reduced dose of tacrolimus
Also known as: Rapamune
everolimus combined to reduced dose of tacrolimus
Also known as: Certican
Control arm: mycophenolate combined to regular tacrolimus
Also known as: mycophenolate sodium
Incidence of Cytomegalovirus Infection or Disease
Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS).
Time frame: 12 months follow up
| Milestone | Sirolimus +Tacrolimus | Everolimus +Tacrolimus | Mycophenolate +Tacrolimus |
|---|---|---|---|
| Started | 403 | 403 | 403 |
| Completed | 86 | 90 | 90 |
| Not completed | 317 | 313 | 313 |
Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS).
| Participants | Sirolimus +Tacrolimus | Everolimus +Tacrolimus | Mycophenolate +Tacrolimus |
|---|---|---|---|
| Incidence of Cytomegalovirus Infection or Disease | 9 | 7 | 39 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sirolimus +Tacrolimus | 2/86 (2.3%) | 43/86 (50%) | 0/86 (0%) |
| Everolimus +Tacrolimus | 1/90 (1.1%) | 47/90 (52.2%) | 0/90 (0%) |
| Mycophenolate +Tacrolimus | 3/90 (3.3%) | 71/90 (78.9%) | 0/90 (0%) |
| Event | Sirolimus +Tacrolimus | Everolimus +Tacrolimus | Mycophenolate +Tacrolimus |
|---|---|---|---|
| OtherGeneral disorders | 19/86 | 19/90 | 28/90 |
| CMV infectionInfections and infestations | 5/86 | 6/90 | 24/90 |
| Acute graft rejectionRenal and urinary disorders | 7/86 | 6/90 | 5/90 |
| PyelonephritisRenal and urinary disorders | 4/86 | 6/90 | 5/90 |
| Acute gastroenterocolitisGastrointestinal disorders | 0/86 | 2/90 | 3/90 |
| Deep vein thrombosisVascular disorders | 2/86 | 1/90 | 0/90 |
| Infection of the operative woundSkin and subcutaneous tissue disorders | 2/86 | 0/90 | 2/90 |
| Dehiscence of the aponeurosisSkin and subcutaneous tissue disorders | 1/86 | 1/90 | 2/90 |
| Acute graft dysfunctionRenal and urinary disorders | 1/86 | 2/90 | 0/90 |
| Sepsis of pulmonary focusRespiratory, thoracic and mediastinal disorders | 0/86 | 2/90 | 0/90 |
| Age, Continuous(years) | Sirolimus +Tacrolimus | Everolimus +Tacrolimus | Mycophenolate +Tacrolimus | Total |
|---|---|---|---|---|
| Mean | 43.35 ± 12.4 | 44.5 ± 14.76 | 44.15 ± 12.32 | 44.01 ± 13.18 |
| Sex: Female, Male(Participants) | Sirolimus +Tacrolimus | Everolimus +Tacrolimus | Mycophenolate +Tacrolimus | Total |
|---|---|---|---|---|
| Female | 22 | 29 | 23 | 74 |
| Male | 64 | 61 | 67 | 192 |
| Race (NIH/OMB)(Participants) | Sirolimus +Tacrolimus | Everolimus +Tacrolimus | Mycophenolate +Tacrolimus | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 7 | 9 | 16 | 32 |
| White | 61 | 56 | 60 | 177 |
| More than one race | 17 | 25 | 13 | 55 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Sirolimus +Tacrolimus | Everolimus +Tacrolimus | Mycophenolate +Tacrolimus | Total |
|---|---|---|---|---|
| Brazil | 86 | 90 | 90 | 266 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2017 to primary completion in Mar 2021, 45 months.
Results were first posted in Apr 2023, 2 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sirolimus · Everolimus
Hospital do Rim e Hipertensão