Disorder Related to Renal TransplantationPhase 4QISNCT06584773
Efficacy of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
A Phase 4 study testing Everolimus and standard maintenance immunosuppression in people with Disorder Related to Renal Transplantation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Disorder Related to Renal Transplantation
- What is being tested?
- Everolimus and standard maintenance immunosuppression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Jul 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.
Who cannot join
- Obese patients (body mass index above 35 m2);
- History of GESF or membranoproliferative glomerulonephritis (MPGN) as primary cause of renal failure;
- Proteinuria (protein/creatinine ratio) greater than 0.5 mg/dL at the time of initiation of Sirolimus;
- Triglyceride levels greater than 300 mg/dl at enrollment;
- Active infection by hepatitis B virus, hepatitis C virus or HIV;
- CMV nonreactive IgG sorology at the time of transplantation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Renal Transplantation Service
São Paulo, 05403-900
Elias David-Neto, MD, PhD, 55-11-2661-8089, elias.david@hc.fm.usp.br
Fabiana Agena, RN, PhD, 55-11-2661-8089, fabiana.agena@hc.fm.usp.br
About this study
Official title: Efficacy and Impact on CMV Infection of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone.
- Being tested
- Everolimus, standard maintenance immunosuppression
- Keywords
- kidney transplantation, sensitized, immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
mTORi added as the fourth maintenance immunosuppressive drug in recipients
standard maintenance immunosuppressionDrug
standard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone
| Study group | Role | What they receive |
|---|---|---|
| standard maintenance immunosuppression | Active comparator | tacrolimus, mycophenolate and prednisone Receives: Drug: standard maintenance immunosuppression |
| fourth maintenance immunosuppressive | Experimental | everolimus, tacrolimus, mycophenolate and prednisone Receives: Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of acute rejection and/or positive viremia for CMV
First occurrence of acute rejection and/or positive viremia for CMV, triggering early treatment within the first year after transplantation in sensitized patients.
Measured: From enrollment to the end of treatment at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study startJun 2015
- Primary completionAug 2024
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Renal TransplantationStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Carlucci G Ventura, Daniel R Salomon, Fabiana Agena, Flavio J de Paula, Francine B Lemos, Gislene Bezerra, Helcio Rodrigues, Maria da Luz Fernandes, Nelson Zocoler Galante, Noemia B de Lima, Paschoalina Romano, Patricia S Souza, Vivian Onuchic, Elias David Neto
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584773
- Sponsor's protocol ID
- CAAE40606115.6.000.0068
- Acronym
- QIS
- Status last verified
- Aug 2024
- First submitted
- 2 Sep 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Impact on CMV Infection of a Quadruple Immunosuppressor Regimen With mTOR Inhibitors in Sensitized Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT06584773
- Acronym / sponsor ID
- QIS / CAAE40606115.6.000.0068
- Keywords
- kidney transplantation, sensitized, immunosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Carlucci G Ventura, Daniel R Salomon, Fabiana Agena, Flavio J de Paula, Francine B Lemos, Gislene Bezerra, Helcio Rodrigues, Maria da Luz Fernandes, Nelson Zocoler Galante, Noemia B de Lima, Paschoalina Romano, Patricia S Souza, Vivian Onuchic, Elias David Neto
- Study start
- Jun 2015
- Primary completion
- Aug 2024 (actual)
- Study completion
- Jul 2025 (estimated)
- First posted
- 5 Sep 2024 (actual)
- 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.
In this study, sensitized renal transplant recipients, who present an increased risk of acute rejection, will be evaluated for the benefit of quadruple immunosuppression, adding sirolimus to the traditional scheme with tacrolimus, mycophenolate, and prednisone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard maintenance immunosuppression | Active comparator | Drug: standard maintenance immunosuppressiontacrolimus, mycophenolate and prednisone |
| fourth maintenance immunosuppressive | Experimental | Drug: Everolimuseverolimus, tacrolimus, mycophenolate and prednisone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Sensitezed renal transplant recipients with reactivity panel of antibodies (PRA) greater than 30% who agree and sign the consent form.
Key exclusion criteria (6 listed)
- Obese patients (body mass index above 35 m2);
- History of GESF or membranoproliferative glomerulonephritis (MPGN) as primary cause of renal failure;
- Proteinuria (protein/creatinine ratio) greater than 0.5 mg/dL at the time of initiation of Sirolimus;
- Triglyceride levels greater than 300 mg/dl at enrollment;
- Active infection by hepatitis B virus, hepatitis C virus or HIV;
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 |
|---|---|---|
| EverolimusmTORi added as the fourth maintenance immunosuppressive drug in recipients | Drug | fourth maintenance immunosuppressive |
| standard maintenance immunosuppressionstandard maintenance immunosuppression: tacrolimus, mycophenolate, prednisone | Drug | standard maintenance immunosuppression |
Primary outcome
Occurrence of acute rejection and/or positive viremia for CMV
Time frame: From enrollment to the end of treatment at 52 weeks
First occurrence of acute rejection and/or positive viremia for CMV, triggering early treatment within the first year after transplantation in sensitized patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Disorder Related to Renal Transplantation
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
Active, not recruitingPhase 2
Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients
Human Papillomavirus Infection, Human Papillomavirus-Related Carcinoma
RecruitingPhase 2
Safety and Tolerability of IDO-1 Inhibition in the Prevention of EBV-related Pathology in EBV Negative Kidney Transplant Recipients Receiving an Organ From EBV Positive Donors
EBV Infections, Kidney Transplant
Active, not recruiting
Curcumin in Kidney Transplant Recipients
Disorder Related to Renal Transplantation
Active, not recruitingObservational study
Proteinuria and Renal Perfusion in Renal Transplant Recipients
Pre-kidney Transplant, Living Donor Kidney Transplantation
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.
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 and standard maintenance immunosuppression in people with Disorder Related to Renal Transplantation, run by University of Sao Paulo General Hospital 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of acute rejection and/or positive viremia for CMV (time frame: From enrollment to the end of treatment at 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2024.