Kidney TransplantationPhase 4ACTIVANCT04936971
Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response
A Phase 4 study testing Switch from Mycophenolate Mofetil to Everolimus manteinance treatment in Active Comparator Arm in people with Kidney Transplantation and Cytomegalovirus Infections, run by Edoardo Melilli at 1 site in Spain.
Trial summary
Kidney transplant patients under an immunosuppressive treatment based on anti-calcineurin and mycophenolate-mofetil and induction therapy with rATG who suffer from early systemic viral replication by the CMV virus could benefit from the introduction of an i-mTor drug. (everolimus) to replace mycophenolate mofetil. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Cytomegalovirus Infections
- What is being tested?
- Switch from Mycophenolate Mofetil to Everolimus manteinance treatment in Active Comparator Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2021to Sep 2021
- 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
- Subjects must be 18 years or older (and weigh more than 34Kg) and may be of both sexes and of any race.
- Subjects will be seropositive for CMV virus and will receive a seropositive graft (CMV IgG D + / R +).
- Subjects must be willing and able to give their written informed consent to the trial. If a subject cannot independently grant their informed consent in writing, her legal representative may do so in her place.
- Women of childbearing potential (WOCBP) must perform a pregnancy test at the time of enrollment and agree to the use of a medically acceptable contraceptive method during the selection period and while receiving the medication specified in the protocol. A woman of childbearing age is considered to be any woman physiologically capable of becoming pregnant, from menarche to becoming postmenopausal, unless she is permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menstruation for 12 months without an alternative medical cause. A high level of follicle stimulating hormone (FSH) in the postmenopausal range can be used to confirm a postmenopausal state in women not using hormonal contraceptives or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- Only women of childbearing age who adhere to the contraceptive methods recommended by the Clinical Trial Facilitation Group (CTFG) as highly effective contraceptive methods may participate, that is, with a failure rate of less than 1% per year when used consistently and correct:
- Combined hormonal contraception (containing estrogen and progestin) associated with inhibition of ovulation (oral, intravaginal or transdermal).
Show all 14Show fewer
- Progestin-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
- Intrauterine device (IUD)
- Intrauterine Hormone Release System (IUS)
- Bilateral tubal occlusion
- Vasectomized partner (provided the partner is the participant's only sexual partner in the WOCBP trial and the vasectomized partner has received a medical evaluation of surgical success)
- Sexual abstinence (defined as abstaining from sexual intercourse for the entire risk period associated with study treatments)
- Patients without a medical contraindication for the use of i-mTOR.
- Immunosuppressive induction rATG.
Who cannot join
- Subjects may not have a history of type I hypersensitivity or idiosyncratic reactions to drugs ganciclovir (GCV) or valganciclovir (VGCV).
- Pregnant women.
- Breastfeeding women.
- Subjects may not have any clinically significant disease that could interfere with study evaluations.
- Participation in another clinical trial promoted by the pharmaceutical industry, in which the promoter already establishes in the protocol what the treatment of CMV should be.
- Patients with active viral replication of the HCV, HBV and / or HIV viruses.
Show all 9Show fewer
- Patients requiring a desensitizing treatment that includes plasma exchange, Campath-1, Rituximab®, Eculizumab® and / or Gammaglobulin.
- Presence of donor-specific antibodies (DSA).
- Prior intolerance to study medication (Certican®), prior documented history of hereditary galactose intolerance, Lapp's lactase deficiency, or glucose or galactose malabsorption.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Effect of the Introduction of mTor Inhibitors in the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response to Control Viral Replication in Kidney Transplant Patients
Kidney transplant patients under an immunosuppressive treatment based on anti-calcineurin and mycophenolate-mofetil and induction therapy with rATG who suffer from early systemic viral replication by the CMV virus could benefit from the introduction of an i-mTor drug. (everolimus) to replace mycophenolate mofetil. This conversion would be effective in slowing down and controlling viral expansion without the need to initiate any prophylactic anti-viral therapy thanks to the activation of the CMV-specific cellular effector response or to an antiviral effect of i-Mtor itself.
Read the detailed description
Human cytomegalovirus (CMV) is the most common opportunistic pathogen in the first months after solid organ transplantation, being associated with an increased risk of acute and chronic graft rejection, graft loss and an increase in patient mortality.
The susceptibility to developing CMV infection is essentially determined by the host's immune status against the virus, with seronegative recipients (IgG-) receiving a graft from a seropositive donor (IgG +) (R- / D +) being the group with an especially high risk of developing CMV infection and disease after transplantation. In fact, without the administration of a preventive therapy for CMV, around 60-70% of this risk group will present viral infection (replication of copies of CMV in blood) and up to 30% will develop systemic disease (viral invasion of the tissue). However, the incidence of infection among R + / D + seropositive (IgG +) patients under treatment with induction with anti-IL2RA and the combination of mycophenolate mofetil (MPA) and anti-calcineurin drugs (CNI), can reach up to 40%, and up to 60% if induction therapies are administered with T-lymphocyte depletors with polyclonal antibodies (Thymoglobulin®, rATG) (6). All this suggests that the assessment of the immunological risk of developing post-transplant CMV infection is relatively poor and that the humoral response to the virus does not fully explain the patient's immunological susceptibility to the virus.
In this sense, it is well known that the subpopulation of CMV-specific memory / effector T cells plays a key role in the control of viral survival replication in general and of CMV in particular. While it has been reported that CD8 + cytotoxic T cells have the ability to activate against a wide range of immunogenic proteins of the CMV virus, it appears that high frequencies directed against the major CMV antigens such as those of immediate expression-1 (IE-1) and phosphoprotein 65 (pp65) play a critical role in the control of CMV viral replication. One of the most precise functional techniques to study the cellular memory immune response is the IFN-γ ELISPOT test, which allows knowing the antigen-specific response at the individual cellular level, thus providing high sensitivity and specificity. Along these lines, our group and others have shown how the monitoring of the CMV-specific cell response with the IFN-γ ELISPOT test, both before and after transplantation, is capable of identifying those patients with a high risk of developing infection by CMV, regardless of immunization status. In addition, data from a prospective, randomized clinical trial led by our group, evaluating the cellular response to CMV before transplantation using the IFN-γ ELISPOT test, have confirmed the high negative predictive power in identifying those patients with high risk of developing viral infection after transplantation, despite being serologically positive.
Mtor (mammalian target of rapamycin) inhibitors, everolimus and sirolimus, are a class of immunosuppressants commonly used in kidney transplantation both in the initial phase (de novo) and in the maintenance phase. In addition, today it is considered routine clinical practice in case of side effects mediated by CNI (tacrolimus or cyclosporine) or by antimetabolites (mycophenolate mofetil or mycophenolic acid) to replace the latter with iMtor (conversion to iMtor).
Interestingly, recently reported clinical studies have shown a significant decrease in the rate of both CMV infection and disease in patients treated with mTor inhibitors (i-mTOR) after kidney transplantation, both in combination with MPA. as in combination with CNI drugs. A recently published randomized clinical trial that included more than 2000 kidney transplant patients has reported that the incidence of CMV viral infection in the CNI plus everolimus group in the Serology D / R + / + group was 3.6% compared to 13.3% of the control group treated with CNI plus mycophenolate mofetil. (RR 0.27 - CI 0.19-0.38) This effect has been reported mainly among R + / D + patients, and even in those after receiving induction treatment with rATG.
Although the mechanism through which i-mTORs can inhibit and block viral replication after transplantation is unknown, it is suggested that it could be through their ability to directly inhibit proliferation on the virus, or well, through some of the immunomodulatory pleiotropic effects that they exert on the adaptive immune response. Along these lines, beyond its immunosuppressive capacity by inhibiting the lymphocyte proliferation signal
- Conditions
- Kidney Transplantation, Cytomegalovirus Infections
- Being tested
- Switch from Mycophenolate Mofetil to Everolimus manteinance treatment in Active Comparator Arm, no intervention
- Keywords
- Cytomegalovirus, kidney transplant, ELISPOT
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switch from Mycophenolate Mofetil to Everolimus manteinance treatment in Active Comparator ArmDrug
Also called Switch to Certican
Switch from Mycophenolate Mofetil in Active comparator Arm if assymptomatic Cytomegalovirus viremia >1000-<5000 copies/mL observed
no interventionOther
Manteinance of assigned Arm treatment even if assymptomatic Cytomegalovirus viremia >1000-<5000 copies/mL observed
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Experimental | Kidney transplant induction with Rabbit Anti-Thymocyte globulin (rATG) as per local practice.
Kidney transplant manteinance treatment with Tacrolimus (TAC) to achieve 4-6 ng/mL trough levels, Everolimus (EVL) to achieve 3-8 ng/mL trough levels and Corticosteroids (CS) as per local practice. Receives: Other: no intervention |
| Mycophenolate Mofetil | Active comparator | Kidney transplant induction with Rabbit Anti-Thymocyte globulin (rATG) as per local practice.
Kidney transplant manteinance treatment with Tacrolimus (TAC) to achieve 4-6 ng/mL trough levels, Mycofenolate Mofetil (MMF) 500mg/bid and Corticosteroids (CS) as per local practice. Receives: Drug: Switch from Mycophenolate Mofetil to Everolimus manteinance treatment in Active Comparator Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who require initiation of anti-viral treatment with valganciclovir
Proportion of patients who require initiation of anti-viral treatment with valganciclovir after reaching a viral replication threshold greater than 5000IU / ml evaluated in plasma being asymptomatic, comparing the different arms
Measured: 3 months
Secondary outcomes (11)
Incidence of CMV disease
Number of patients with symptomatic CMV disease in each arm
Measured: 3 months
Recurrence of CMV infection after initiation of anti-viral treatment
Number of patients with CMV infection after initiation of anti-viral treatment
Measured: 3 months
Recurrence of CMV infection after switch to everolimus treatment
Number of patients with CMV infection after switch to everolimus treatment
Measured: 3 months
Kinetic of the CMV-specific cellular response
Changes in the CMV-specific cellular response against 2 major CMV antigens (Ie-1 and Pp65) by IFN-γ ELISPOT technique
Measured: 3 months
Titration of anti-CMV antibodies in serum
Changes in the titration of anti-CMV antibodies in serum by ELISA technique
Measured: 3 months
Evaluation of the anti-CMV specific memory B cell response
Changes in CMV-specific memory B cell response by ELISPOT technique
Measured: 3 months
Incidence of acute clinical graft rejection
Number of patients with acute clinical graft rejection
Measured: 3 months
Incidence of acute subclinical graft rejection
Incidence of acute subclinical graft rejection between both study groups evaluated in protocol biopsies 3 months after transplantation
Measured: 3 months
Estimated Glomerular Filtration Rate (eGFR)
Changes in eGFR between both study groups
Measured: 3 months
Incidence of toxic side effects associated with the drug everolimus
Number of toxic side effects associated with the drug everolimus reported
Measured: 3 months
Withdrawal of Everolimus treatment due to Adverse Events
Number of patients that discontinue Everolimus treatment due to Everolimus related Adverse Events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: Impossibility to perform tests (elispot) of the study due to change of location of laboratory
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, open label, randomized, two arms, paralel, compared to Standard of Care treatment
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edoardo Melilli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edoardo Melilli, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936971
- Sponsor's protocol ID
- ACTIVA
- Acronym
- ACTIVA
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Introduction of mTor Inhibitors in the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response to Control Viral Replication in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT04936971
- Acronym / sponsor ID
- ACTIVA / ACTIVA
- Conditions
- Kidney Transplantation, Cytomegalovirus Infections
- Keywords
- Cytomegalovirus, kidney transplant, ELISPOT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Impossibility to perform tests (elispot) of the study due to change of location of laboratory
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Edoardo MelilliUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 23 Jun 2021 (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.
Kidney transplant patients under an immunosuppressive treatment based on anti-calcineurin and mycophenolate-mofetil and induction therapy with rATG who suffer from early systemic viral replication by the CMV virus could benefit from the introduction of an i-mTor drug. (everolimus) to replace mycophenolate mofetil. This conversion would be effective in slowing down and controlling viral expansion without the need to initiate any prophylactic anti-viral therapy thanks to the activation of the CMV-specific cellular effector response or to an antiviral effect of i-Mtor itself.
Detailed description
Human cytomegalovirus (CMV) is the most common opportunistic pathogen in the first months after solid organ transplantation, being associated with an increased risk of acute and chronic graft rejection, graft loss and an increase in patient mortality.
The susceptibility to developing CMV infection is essentially determined by the host's immune status against the virus, with seronegative recipients (IgG-) receiving a graft from a seropositive donor (IgG +) (R- / D +) being the group with an especially high risk of developing CMV infection and disease after transplantation. In fact, without the administration of a preventive therapy for CMV, around 60-70% of this risk group will present viral infection (replication of copies of CMV in blood) and up to 30% will develop systemic disease (viral invasion of the tissue). However, the incidence of infection among R + / D + seropositive (IgG +) patients under treatment with induction with anti-IL2RA and the combination of mycophenolate mofetil (MPA) and anti-calcineurin drugs (CNI), can reach up to 40%, and up to 60% if induction therapies are administered with T-lymphocyte depletors with polyclonal antibodies (Thymoglobulin®, rATG) (6). All this suggests that the assessment of the immunological risk of developing post-transplant CMV infection is relatively poor and that the humoral response to the virus does not fully explain the patient's immunological susceptibility to the virus.
In this sense, it is well known that the subpopulation of CMV-specific memory / effector T cells plays a key role in the control of viral survival replication in general and of CMV in particular. While it has been reported that CD8 + cytotoxic T cells have the ability to activate against a wide range of immunogenic proteins of the CMV virus, it appears that high frequencies directed against the major CMV antigens such as those of immediate expression-1 (IE-1) and phosphoprotein 65 (pp65) play a critical role in the control of CMV viral replication. One of the most precise functional techniques to study the cellular memory immune response is the IFN-γ ELISPOT test, which allows knowing the antigen-specific response at the individual cellular level, thus providing high sensitivity and specificity. Along these lines, our group and others have shown how the monitoring of the CMV-specific cell response with the IFN-γ ELISPOT test, both before and after transplantation, is capable of identifying those patients with a high risk of developing infection by CMV, regardless of immunization status. In addition, data from a prospective, randomized clinical trial led by our group, evaluating the cellular response to CMV before transplantation using the IFN-γ ELISPOT test, have confirmed the high negative predictive power in identifying those patients with high risk of developing viral infection after transplantation, despite being serologically positive.
Mtor (mammalian target of rapamycin) inhibitors, everolimus and sirolimus, are a class of immunosuppressants commonly used in kidney transplantation both in the initial phase (de novo) and in the maintenance phase. In addition, today it is considered routine clinical practice in case of side effects mediated by CNI (tacrolimus or cyclosporine) or by antimetabolites (mycophenolate mofetil or mycophenolic acid) to replace the latter with iMtor (conversion to iMtor).
Interestingly, recently reported clinical studies have shown a significant decrease in the rate of both CMV infection and disease in patients treated with mTor inhibitors (i-mTOR) after kidney transplantation, both in combination with MPA. as in combination with CNI drugs. A recently published randomized clinical trial that included more than 2000 kidney transplant patients has reported that the incidence of CMV viral infection in the CNI plus everolimus group in the Serology D / R + / + group was 3.6% compared to 13.3% of the control group treated with CNI plus mycophenolate mofetil. (RR 0.27 - CI 0.19-0.38) This effect has been reported mainly among R + / D + patients, and even in those after receiving induction treatment with rATG.
Although the mechanism through which i-mTORs can inhibit and block viral replication after transplantation is unknown, it is suggested that it could be through their ability to directly inhibit proliferation on the virus, or well, through some of the immunomodulatory pleiotropic effects that they exert on the adaptive immune response. Along these lines, beyond its immunosuppressive capacity by inhibiting the lymphocyte proliferation signal
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open label, randomized, two arms, paralel, compared to Standard of Care treatment
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Experimental | Other: no interventionKidney transplant induction with Rabbit Anti-Thymocyte globulin (rATG) as per local practice. Kidney transplant manteinance treatment with Tacrolimus (TAC) to achieve 4-6 ng/mL trough levels, Everolimus (EVL) to achieve 3-8 ng/mL trough levels and Corticosteroids (CS) as per local practice. |
| Mycophenolate Mofetil | Active comparator | Drug: Switch from Mycophenolate Mofetil to Everolimus manteinance treatment in Active Comparator ArmKidney transplant induction with Rabbit Anti-Thymocyte globulin (rATG) as per local practice. Kidney transplant manteinance treatment with Tacrolimus (TAC) to achieve 4-6 ng/mL trough levels, Mycofenolate Mofetil (MMF) 500mg/bid and Corticosteroids (CS) as per local practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must be 18 years or older (and weigh more than 34Kg) and may be of both sexes and of any race.
- Subjects will be seropositive for CMV virus and will receive a seropositive graft (CMV IgG D + / R +).
- Subjects must be willing and able to give their written informed consent to the trial. If a subject cannot independently grant their informed consent in writing, her legal representative may do so in her place.
- Women of childbearing potential (WOCBP) must perform a pregnancy test at the time of enrollment and agree to the use of a medically acceptable contraceptive method during the selection period and while receiving the medication specified in the protocol. A woman of childbearing age is considered to be any woman physiologically capable of becoming pregnant, from menarche to becoming postmenopausal, unless she is permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menstruation for 12 months without an alternative medical cause. A high level of follicle stimulating hormone (FSH) in the postmenopausal range can be used to confirm a postmenopausal state in women not using hormonal contraceptives or hormone replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- Only women of childbearing age who adhere to the contraceptive methods recommended by the Clinical Trial Facilitation Group (CTFG) as highly effective contraceptive methods may participate, that is, with a failure rate of less than 1% per year when used consistently and correct:
Key exclusion criteria (9 listed)
- Subjects may not have a history of type I hypersensitivity or idiosyncratic reactions to drugs ganciclovir (GCV) or valganciclovir (VGCV).
- Pregnant women.
- Breastfeeding women.
- Subjects may not have any clinically significant disease that could interfere with study evaluations.
- Participation in another clinical trial promoted by the pharmaceutical industry, in which the promoter already establishes in the protocol what the treatment of CMV should be.
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 |
|---|---|---|
| Switch from Mycophenolate Mofetil to Everolimus manteinance treatment in Active Comparator ArmAlso: Switch to CerticanSwitch from Mycophenolate Mofetil in Active comparator Arm if assymptomatic Cytomegalovirus viremia >1000-<5000 copies/mL observed | Drug | Mycophenolate Mofetil |
| no interventionManteinance of assigned Arm treatment even if assymptomatic Cytomegalovirus viremia >1000-<5000 copies/mL observed | Other | Everolimus |
Primary outcome
Proportion of patients who require initiation of anti-viral treatment with valganciclovir
Time frame: 3 months
Proportion of patients who require initiation of anti-viral treatment with valganciclovir after reaching a viral replication threshold greater than 5000IU / ml evaluated in plasma being asymptomatic, comparing the different arms
11 secondary outcomes
Incidence of CMV disease
Time frame: 3 months
Recurrence of CMV infection after initiation of anti-viral treatment
Time frame: 3 months
Recurrence of CMV infection after switch to everolimus treatment
Time frame: 3 months
Kinetic of the CMV-specific cellular response
Time frame: 3 months
Titration of anti-CMV antibodies in serum
Time frame: 3 months
Evaluation of the anti-CMV specific memory B cell response
Time frame: 3 months
Incidence of acute clinical graft rejection
Time frame: 3 months
Incidence of acute subclinical graft rejection
Time frame: 3 months
Estimated Glomerular Filtration Rate (eGFR)
Time frame: 3 months
Incidence of toxic side effects associated with the drug everolimus
Time frame: 3 months
Withdrawal of Everolimus treatment due to Adverse Events
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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 Switch from Mycophenolate Mofetil to Everolimus manteinance treatment in Active Comparator Arm in people with Kidney Transplantation and Cytomegalovirus Infections, run by Edoardo Melilli at 1 site in Spain.
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 14 inclusion and 9 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: withdrawn, as of the sponsor's last update on 28 Feb 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients who require initiation of anti-viral treatment with valganciclovir (time frame: 3 months). 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 28 Feb 2024.