Kidney Transplant InfectionPhase 4SEMNCT03468478

Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation

A Phase 4 study testing Sirolimus, Everolimus and Mycophenolic acid in people with Kidney Transplant Infection, run by Hospital do Rim e Hipertensão at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Transplant Infection
What is being tested?: Sirolimus, Everolimus and Mycophenolic acid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,209 participants
Where: 1 siteBrazil
Study dates: 18 Jun 2017to 23 Aug 2021
Phase: Phase 4
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

Recipients, adults of the first living or deceased donor kidney transplant;
Patients who agreed to participate in the study and signed the informed consent form

Who cannot join

Receptors with a medical history of nephrotic syndrome or focal and segmental glomerulosclerosis confirmed as the etiology of end-stage renal disease;
Receptors with poor understanding about chronic kidney disease and its treatment alternatives;
Receptors with early history of non compliance to treatment with immunosuppressive drugs;
Retransplantation;
Multi-organ recipients;
Recipients with BMI> 30 kg / m2;

Show all 13Show fewer

KDPI> 80%;
Cold ischemia time greater than 24 hours;
Receptors with a percentage of anti-HLA antibodies above 50%, either class I or Class II;
Women of childbearing potential who do not undertake contraceptive methods (condoms or oral contraceptives).
Patients receiving immunosuppressive therapy prior to transplantation, except low dose of prednisone;
Patients with severe uncontrolled dyslipidemia;
Patients who have a known contraindication for administration of any of the immunosuppressive drugs provided for in this study;

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Hospital do Rim
São Paulo, São Paulo, 04038002

Other trials in Brazil

About this study

Official title: Comparison of the Efficacy and Safety of Sirolimus, Everolimus or Mycophenolate in Renal Transplant Recipients Receiving Induction With Anti-thymocyte Globulin, Tacrolimus and Prednisone

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.

Conditions: Kidney Transplant Infection
Being tested: Sirolimus, Everolimus, Mycophenolic acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SirolimusDrug
Also called Rapamune
sirolimus combined to reduced dose of tacrolimus
EverolimusDrug
Also called Certican
everolimus combined to reduced dose of tacrolimus
Mycophenolic acidDrug
Also called mycophenolate sodium
Control arm: mycophenolate combined to regular tacrolimus

Study groups in NCT03468478
Study group	Role	What they receive
sirolimus +tacrolimus	Experimental	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. Receives: Drug: Sirolimus
everolimus +tacrolimus	Experimental	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. Receives: Drug: Everolimus
mycophenolate +tacrolimus	Active comparator	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). Receives: Drug: Mycophenolic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Cytomegalovirus Infection or Disease
Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS).
Measured: 12 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 201723 Aug 2021

First posted16 Mar 2018
Study start18 Jun 2017
Primary completion18 Mar 2021
Study completion23 Aug 2021

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 Kidney Transplant 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: 1,209 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03468478
Sponsor's protocol ID: HRHipertensao
Acronym: SEM
Status last verified: Apr 2023
First submitted: 9 Mar 2018
Last updated: 24 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Toniato de Rezende Freschi J, Cristelli MP, Viana LA, Ficher KN, Nakamura MR, Proenca H, Dreige YC, de Marco R, de Lima MG, Foresto RD, Aguiar WF, Medina-Pestana J, Tedesco-Silva H. A Head-to-head Comparison of De Novo Sirolimus or Everolimus Plus Reduced-dose Tacrolimus in Kidney Transplant Recipients: A Prospective and Randomized Trial. Transplantation. 2024 Jan 1;108(1):261-275. doi: 10.1097/TP.0000000000004749. Epub 2023 Aug 1.
PubMed 37525373

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Not yet recruitingPhase 3
Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
Kidney Transplant Infection, Bloodstream Infection
RecruitingPhase 1/2
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8

All Kidney Transplant Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Efficacy and Safety of Sirolimus, Everolimus or Mycophenolate in Renal Transplant Recipients Receiving Induction With Anti-thymocyte Globulin, Tacrolimus and Prednisone
ClinicalTrials.gov ID: NCT03468478
Acronym / sponsor ID: SEM / HRHipertensao
Conditions: Kidney Transplant Infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,209 participants (actual)
Lead sponsor: Hospital do Rim e HipertensãoUniversity, hospital or other
Study start: 18 Jun 2017 (actual)
Primary completion: 18 Mar 2021 (actual)
Study completion: 23 Aug 2021 (actual)
First posted: 16 Mar 2018 (actual)
Results: Posted 24 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
sirolimus +tacrolimus	Experimental	Drug: SirolimusPatients 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.
everolimus +tacrolimus	Experimental	Drug: EverolimusPatients 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.
mycophenolate +tacrolimus	Active comparator	Drug: Mycophenolic acidPatients 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Recipients, adults of the first living or deceased donor kidney transplant;
Patients who agreed to participate in the study and signed the informed consent form

Key exclusion criteria (13 listed)

Receptors with a medical history of nephrotic syndrome or focal and segmental glomerulosclerosis confirmed as the etiology of end-stage renal disease;
Receptors with poor understanding about chronic kidney disease and its treatment alternatives;
Receptors with early history of non compliance to treatment with immunosuppressive drugs;
Retransplantation;
Multi-organ recipients;

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
SirolimusAlso: Rapamunesirolimus combined to reduced dose of tacrolimus	Drug	sirolimus +tacrolimus
EverolimusAlso: Certicaneverolimus combined to reduced dose of tacrolimus	Drug	everolimus +tacrolimus
Mycophenolic acidAlso: mycophenolate sodiumControl arm: mycophenolate combined to regular tacrolimus	Drug	mycophenolate +tacrolimus

Primary outcome

Incidence of Cytomegalovirus Infection or Disease
Time frame: 12 months follow up
Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS).

Results and safety

Results posted to the registry on 24 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sirolimus +Tacrolimus	403	86
Everolimus +Tacrolimus	403	90
Mycophenolate +Tacrolimus	403	90

Primary outcome: Incidence of Cytomegalovirus Infection or Disease

Time frame: 12 months follow up. Count of participants. Unit: Participants

Measure	Sirolimus +Tacrolimus n = 86	Everolimus +Tacrolimus n = 90	Mycophenolate +Tacrolimus n = 90
Value	9	7	39

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sirolimus +Tacrolimus	43 of 86 (50%)	0 of 86 (0%)	2 of 86
Everolimus +Tacrolimus	47 of 90 (52.2%)	0 of 90 (0%)	1 of 90
Mycophenolate +Tacrolimus	71 of 90 (78.9%)	0 of 90 (0%)	3 of 90

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37525373Toniato de Rezende Freschi J, Cristelli MP, Viana LA, Ficher KN, Nakamura MR, Proenca H, Dreige YC, de Marco R, de Lima MG, Foresto RD, Aguiar WF, Medina-Pestana J, Tedesco-Silva H. A Head-to-head Comparison of De Novo Sirolimus or Everolimus Plus Reduced-dose Tacrolimus in Kidney Transplant Recipients: A Prospective and Randomized Trial. Transplantation. 2024 Jan 1;108(1):261-275. doi: 10.1097/TP.0000000000004749. Epub 2023 Aug 1.
Individual participant dataSharing planned: No

Related trials for Kidney Transplant Infection

Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Not yet recruitingPhase 3
Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
Kidney Transplant Infection, Bloodstream Infection
RecruitingPhase 1/2
Immunotherapy in Combination With Prednisone and Sirolimus for Kidney Transplant Recipients With Unresectable or Metastatic Skin Cancer
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8

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 Sirolimus, Everolimus and Mycophenolic acid in people with Kidney Transplant Infection, run by Hospital do Rim e Hipertensão 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 2 inclusion and 13 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 24 Apr 2023. 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?

Yes. Results are posted in the registry (first posted 24 Apr 2023). 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?

Incidence of Cytomegalovirus Infection or Disease (time frame: 12 months follow up). 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 NCT03468478, 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 24 Apr 2023.