Cytomegalovirus InfectionsPhase 4StopCMVNCT02671318
Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence
A Phase 4 study testing Drug conversion to sirolimus and Maintenance of the current regimen in people with Cytomegalovirus Infections, run by Hospital do Rim e Hipertensão at 1 site in Brazil.
Trial summary
Cytomegalovirus is the most important opportunistic infection after kidney transplant, with increased in mortality, morbidity and higher costs of transplantation. Despite the favorable efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus, mycophenolate and prednisone, or the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- Drug conversion to sirolimus and Maintenance of the current regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2015to Aug 2020
- 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
- Adult kidney transplant recipients > 18 y.o.
- Kidney Transplant recipients, after the first episode of cytomegalovirus infection, using the current immunosuppressive regimen: azathioprine or mycophenolate, tacrolimus and prednisone.
Who cannot join
- Re-transplant;
- Patients with any panel reactive antibody (PRA) equal to or above 50%, class I or class II;
- Acute rejection episode in the last 30 days, or episode > 2A in the Banff criteria;
- GFR (MDRD) < 40 ml/min;
- Proteinuria > 0,5 g/l;
- Hemoglobin < 10 g/l and/or leucocytes < 4000 cels/mm3 and/or platelets < 150.000 cels/mm3;
Show all 12Show fewer
- Triglycerides > 500 mg/dl with or without use of fibrate;
- Cholesterol total > 300 mg/dl with or without use of statin;
- Hepatic abnormalities;
- Significant periphery edema;
- Pulmonary abnormalities or breast x-ray abnormalities;
- Hyper sensibility to sirolimus formula;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital do Rim
São Paulo, São Paulo, 04037-003
Geovana Basso, MD, +55 11 5087-8000, geovana_basso@hotmail.com
About this study
Official title: Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence in Kidney Transplant Recipients (StopCMV: S=Sirolimus CMV= Cytomegalovirus)
Cytomegalovirus is the most important opportunistic infection after kidney transplant, with increased in mortality, morbidity and higher costs of transplantation. Despite the favorable efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus, mycophenolate and prednisone, or the investigators local common regimen, tacrolimus, azathioprine and prednisone, this combinations are associated with higher incidence of cytomegalovirus infection, disease and recurrence.
Namely, sirolimus use is associated with decreased risk of cytomegalovirus infection/disease, and there is not a prospective cohort to evaluate the conversion to sirolimus efficacy to decrease the cytomegalovirus infection recurrence.
Given this, the investigators propose a study of their own initiative that attends local needs: evaluate the conversion to sirolimus efficacy in decrease the cytomegalovirus recurrence after kidney transplant.
Read the detailed description
This protocol is a prospective, randomized, single center, designed to evaluate incidence of cytomegalovirus recurrence infection/disease in two immunosuppressive regimens, after the first episode of cytomegalovirus: (1) conversion of azathioprine or mycophenolate to sirolimus, in a regimen wih low doses tacrolimus and prednisone; ( 2) Maintenance of the current regimen during the first episode of cytomegalovirus infection ( azathioprine or mycophenolate, in combination to tacrolimus or prednisone). Our hypothesis is that conversion from azathioprine or sodium mycophenolate to sirolimus, with low doses of tacrolimus, and prednisone results in lower recurrence of cytomegalovirus infection/disease in kidney transplant recipients.
- Conditions
- Cytomegalovirus Infections
- Being tested
- Drug conversion to sirolimus, Maintenance of the current regimen
- Keywords
- cytomegalovirus, sirolimus, cytomegalovirus recurrence, kidney transplant, conversion
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug conversion to sirolimusDrug
Also called Rapamune
Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone.
Maintenance of the current regimenDrug
Also called Myfortic, Immuran
Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone.
| Study group | Role | What they receive |
|---|---|---|
| Drug conversion to sirolimus | Active comparator | Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone. Receives: Drug: Drug conversion to sirolimus |
| Maintenance of the current regimen | Active comparator | Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone. Receives: Drug: Maintenance of the current regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytomegalovirus infection/disease recurrence
Cytomegalovirus infection/disease recurrence
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2019 (estimated)
- Study completionAug 2020 (estimated)
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 Cytomegalovirus InfectionsStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Rim e Hipertensão
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geovana Basso, Hospital do Rim e Hipertensão
- Investigators
- Geovana Basso, MD, Principal investigator, Nephrology Division, Hospital do Rim, Federal University of São Paulo, BrazilHelio Tedesco Silva Junior, PhD, Study chair, Nephrology Division, Hospital do Rim, Federal University of São Paulo, BrazilClaudia Rosso felipe, PhD, Study chair, Nephrology Division, Hospital do Rim, Federal University of São Paulo, BrazilLeonardo V. Riella, PhD, Study chair, Brigham and Women's Hospital, US.Jose O. Medina Pestana, PhD, Study chair, Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671318
- Sponsor's protocol ID
- 43102815.0.0000.5505
- Acronym
- StopCMV
- Status last verified
- Aug 2016
- First submitted
- 26 Jan 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Viana LA, Cristelli MP, Basso G, Santos DW, Dantas MTC, Dreige YC, Requiao Moura LR, Nakamura MR, Medina-Pestana J, Tedesco-Silva H. Conversion to mTOR Inhibitor to Reduce the Incidence of Cytomegalovirus Recurrence in Kidney Transplant Recipients Receiving Preemptive Treatment: A Prospective, Randomized Trial. Transplantation. 2023 Aug 1;107(8):1835-1845. doi: 10.1097/TP.0000000000004559. Epub 2023 Jul 20.
PubMed 37046380
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion to Sirolimus: Effects in Cytomegalovirus Infection Recurrence in Kidney Transplant Recipients (StopCMV: S=Sirolimus CMV= Cytomegalovirus)
- ClinicalTrials.gov ID
- NCT02671318
- Acronym / sponsor ID
- StopCMV / 43102815.0.0000.5505
- Conditions
- Cytomegalovirus Infections
- Keywords
- cytomegalovirus, sirolimus, cytomegalovirus recurrence, kidney transplant, conversion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospital do Rim e HipertensãoUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 2 Feb 2016 (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.
Cytomegalovirus is the most important opportunistic infection after kidney transplant, with increased in mortality, morbidity and higher costs of transplantation. Despite the favorable efficacy (lower acute rejection) results of the most worldwide used regime, tacrolimus, mycophenolate and prednisone, or the investigators local common regimen, tacrolimus, azathioprine and prednisone, this combinations are associated with higher incidence of cytomegalovirus infection, disease and recurrence.
Namely, sirolimus use is associated with decreased risk of cytomegalovirus infection/disease, and there is not a prospective cohort to evaluate the conversion to sirolimus efficacy to decrease the cytomegalovirus infection recurrence.
Given this, the investigators propose a study of their own initiative that attends local needs: evaluate the conversion to sirolimus efficacy in decrease the cytomegalovirus recurrence after kidney transplant.
Detailed description
This protocol is a prospective, randomized, single center, designed to evaluate incidence of cytomegalovirus recurrence infection/disease in two immunosuppressive regimens, after the first episode of cytomegalovirus: (1) conversion of azathioprine or mycophenolate to sirolimus, in a regimen wih low doses tacrolimus and prednisone; ( 2) Maintenance of the current regimen during the first episode of cytomegalovirus infection ( azathioprine or mycophenolate, in combination to tacrolimus or prednisone). Our hypothesis is that conversion from azathioprine or sodium mycophenolate to sirolimus, with low doses of tacrolimus, and prednisone results in lower recurrence of cytomegalovirus infection/disease in kidney transplant recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug conversion to sirolimus | Active comparator | Drug: Drug conversion to sirolimusDrug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone. |
| Maintenance of the current regimen | Active comparator | Drug: Maintenance of the current regimenMaintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult kidney transplant recipients > 18 y.o.
- Kidney Transplant recipients, after the first episode of cytomegalovirus infection, using the current immunosuppressive regimen: azathioprine or mycophenolate, tacrolimus and prednisone.
Key exclusion criteria (12 listed)
- Re-transplant;
- Patients with any panel reactive antibody (PRA) equal to or above 50%, class I or class II;
- Acute rejection episode in the last 30 days, or episode > 2A in the Banff criteria;
- GFR (MDRD) < 40 ml/min;
- Proteinuria > 0,5 g/l;
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 |
|---|---|---|
| Drug conversion to sirolimusAlso: RapamuneDrug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone. | Drug | Drug conversion to sirolimus |
| Maintenance of the current regimenAlso: Myfortic, ImmuranMaintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone. | Drug | Maintenance of the current regimen |
Primary outcome
Cytomegalovirus infection/disease recurrence
Time frame: One year
Cytomegalovirus infection/disease recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Derived from this study: PubMed 37046380Viana LA, Cristelli MP, Basso G, Santos DW, Dantas MTC, Dreige YC, Requiao Moura LR, Nakamura MR, Medina-Pestana J, Tedesco-Silva H. Conversion to mTOR Inhibitor to Reduce the Incidence of Cytomegalovirus Recurrence in Kidney Transplant Recipients Receiving Preemptive Treatment: A Prospective, Randomized Trial. Transplantation. 2023 Aug 1;107(8):1835-1845. doi: 10.1097/TP.0000000000004559. Epub 2023 Jul 20.
- Individual participant dataSharing planned: Undecided
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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.
Geovana Basso, MD principal investigator
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
Helio Tedesco Silva Junior, PhD study chair
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
Claudia Rosso felipe, PhD study chair
Nephrology Division, Hospital do Rim, Federal University of São Paulo, Brazil
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 Drug conversion to sirolimus and Maintenance of the current regimen in people with Cytomegalovirus Infections, 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 12 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 17 Aug 2016. 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?
Contact Geovana Basso, MD (+55 11 50878000, geovana_basso@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytomegalovirus infection/disease recurrence (time frame: One 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 NCT02671318, 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 17 Aug 2016.