Transplantation InfectionPhase 4EVERCMVNCT02328963

Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A

A Phase 4 study testing Everolimus and mycophenolic acid in people with Transplantation Infection and Cytomegalovirus Infection, run by University Hospital, Bordeaux at 9 sites in France.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Transplantation Infection, Cytomegalovirus Infection
What is being tested?: Everolimus and mycophenolic acid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 186 participants
Where: 9 sitesFrance
Study dates: 2 May 2014to 10 Oct 2018
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

Age ≥ 18 years.
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation.
Patient seropositive for CMV (confirmed within two weeks post-transplant) and having received an allograft from a CMV seropositive or seronegative donor.
Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type.
Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study and two months later the discontinuation of the test drug.
Total ischemia time below 36 hours.

Show all 9Show fewer

Capable of understanding the purpose and risks of the study.
Fully informed and having given written informed consent (signed Informed Consent has been obtained).
Affiliation to the social security regimen

Who cannot join

CMV seronegative patient.
Historical or current TGI (French equivalence of calculated PRA) > 85 %
Presence of historical or current anti-HLA donor specific antibodies
Patient who received anti-CMV therapy within the past 30 days prior to screening.
Receiving or having previously received an organ transplant other than a kidney.
Receiving a graft from a non-heart-beating donor.

Show all 18Show fewer

Patient known to be positive for Human Immunodeficiency Virus (HIV), Hepatitis B (HBV; HBs Ag positive) or Hepatitis C (HCV; anti-HCV Ab positive).elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels ≥ 2 times the upper value of the normal range of the investigational site or receiving a graft from a hepatitis C or B positive donor.
Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
Known allergy or intolerance to everolimus, valganciclovir, ganciclovir, mycophenolic acid, basiliximab, corticosteroids, or cyclosporine A or any of the product excipients.
Severe hyperlipidemia defined by: total cholestérol ≥ 9,1 mmol/L (≥ 350 mg/dL) et/ou triglycérides ≥ 8,5 mmol/l (≥ 750 mg/dL) in spite an adequate medication.
Patient has adequate hematological post-transplant defined as:
Absolute neutrophil count (ANC) > 1000 cells/μL.
Platelet count > 50,000 cells/μL.
Hemoglobin > 8.0 g/dL.
Requiring initial therapy with induction immunosuppressive antibody preparations, such as anti-thymocyte globulins or rituximab or IVIG.
Currently participating in another clinical trial investigating drugs. Observational studies are not considered as an exclusion criteria
Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
Unlikely to comply with the visits scheduled in the protocol.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

France9 sites

CHU de Bordeaux
Bordeaux, 33000
CHU La Cavale Blanche
Brest, 29609
CHRU Caen - Hôpital de Caen
Caen, 14033
CHU de Limoges - Hôpital Dupuytren
Limoges
Hôpital Edouard Herriot
Lyon, 69003
APHP - Hôpital Necker
Paris, 75015
APHP - Kremlin Bicetre
Paris, 94275
CHRU Strasbourg
Strasbourg
CHU de Toulouse - Hôpital Rangueil
Toulouse, 31000

Other trials in France

About this study

Official title: A Multicenter, Two Arms, Randomized, Open Label Clinical Phase IV Study Investigating the Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection Within the First 6 Months Post-transplantation When Treated With an Immunosuppressive Regimen Including Everolimus (Certican®) and Reduced Dose of Cyclosporine A (Neoral®) Versus an Immunosuppressive Regimen With Mycophenolic Acid (Myfortic®) and Standard Dose of Cyclosporine A (Neoral®).

Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after transplantation. It is associated with an increased incidence of acute rejection and lower graft and patient survivals. The goal of this study is to demonstrate that an immunosuppressive regimen associating everolimus and reduced dose of cyclosporine A can prevent acute rejection episodes as efficiently as standard regimen but also efficiently reduce the incidence of CMV infection at 6 months post-transplantation.

Read the detailed description

Cytomegalovirus (CMV) infection is the most frequent opportunistic viral infection after kidney transplantation. Therefore most of the patients receive an universal prophylaxis. On the contrary to CMV naïve patients, seropositive recipients (R+) have already mounted a specific immunologic response directed against the virus, which is not completely abrogated by immunosuppressive drugs. Although CMV infection management guidelines offer little guidance on immunosuppressive therapy for preventing CMV infection and disease, recent data plead for reappraising the place of mTOR inhibitors in this situation. The potential anti-CMV action of these molecules could be added to their potential antitumor effect and their equivalent immunosuppressive efficacy in kidney transplant recipients at low immunological risk. By the way, it could represent an alternative of a systematic universal prophylaxis in R+ kidney transplant recipients. However, the proof of this anti-CMV action must be confirmed in vivo in a study, which could have a close monitoring of CMV infection.

We therefore designed a prospective multicentric randomized controlled trial comparing an immunosuppressive regimen based on everolimus and reduced dose of cyclosporine A to a regimen based on mycophenolic acid and standard dose of cyclosporine A, in order to demonstrate the superiority of the first one in the prevention of CMV infection.

Subjects will be randomized to one of the two treatment arms and will be followed for a period of 12 months. Whole blood CMV real time PCR will be performed every week during the first three months, then every two weeks from Month 3 to Month 6, then at Months 8, 10 and 12. Incidence of CMV infection will be compared between the two arms at 6 and 12 months post-transplantation.

Conditions: Transplantation Infection, Cytomegalovirus Infection
Being tested: Everolimus, mycophenolic acid
Keywords: Cytomegalovirus infection and disease, CMV-seropositive recipients, Everolimus, preemptive strategy, mTOR inhibitor
Medical subject headings: Cytomegalovirus Infections, Disease

What participants receive

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

EverolimusDrug
Everolimus : 0.75 bid, targeted to 3-8 ng/ml
Cyclosporin A :
CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12.
Corticosteroids :
Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study
Basiliximab :Day 0: 20 mg ; Day 4: 20 mg
mycophenolic acidDrug
Mycophenolic acid :
1080 mg bid for one month, then 720 mg bid
Cyclosporin A :
CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12.
Corticosteroids :
Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study
Basiliximab :Day 0: 20 mg ; Day 4: 20 mg

Study groups in NCT02328963
Study group	Role	What they receive
Everolimus	Experimental	Everolimus + reduced dose of cyclosporine A Receives: Drug: Everolimus
mycophenolic acid	Active comparator	mycophenolic acid + standard dose of cyclosporin A Receives: Drug: mycophenolic acid

What is being measured

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

Number of participants without CMV infection and without graft loss in CMV seropositive kidney transplant recipients.
The primary objective of this study is to compare the survival without CMV infection and without graft loss in CMV seropositive kidney transplant recipients, within the first 6 months post-transplantation when treated with an immunosuppressive regimen including everolimus (Certican®) and reduced dose (RD) of cyclosporine A (Néoral®) versus an immunosuppressive regimen with mycophenolic acid (Myfortic®) and standard dose (SD) of cyclosporine A (Néoral®).
Measured: 6 months post-transplantation

Secondary outcomes (23)

Proportion of patients who will develop CMV disease
The proportion of patients who will develop CMV disease during the first 6 and 12 months post-transplantation (CMV disease includes both CMV syndrome and CMV tissue-invasive disease).
Measured: 6 and 12 months post-transplantation
Proportion of patient with graft loss, death and loss of follow-up
Measured: 12 months post-transplantation
Proportion of patient with acute rejection, graft loss, death and loss of follow-u
Measured: 12 months
Level to the first CMV DNAemia
Measured: Throughout the study
Time to the first CMV disease
Measured: Throughout the study
Proportion of patients treated for CMV infection in both groups
Measured: 6 months
Half-life of decreasing of DNAemia
Measured: after initiation of anti-CMV therapy
Occurrence of treatment failure, defined as the absence of viral eradication.
Measured: Day 49 (or 8 weeks) after the initiation of anti-CMV therapy
Occurrence of CMV mutation (UL97 ou UL54) associated with a resistance to an anti-CMV therapy.
Measured: Throughout the study
Graft function
Graft function defined as glomerular filtration rate (GFR) estimated by simplified MDRD formula and proteinuria/creatininuria ratio.
Measured: 6 and 12 months post-transplantation
Proportion of patients with biopsy-proven acute rejection (BPAR)
Measured: 6 and 12 months post-transplantation
Degree of interstitial fibrosis/tubular atrophy
Measured: 12 months on protocol biopsies
Graft and patient survival
Measured: 6 and 12 months post-transplantation
Proportion of BK virus viremia
Measured: month 1, 3, 6 and 12
Proportion of patients with adverse events (AE) and/or serious adverse events (SAE) including opportunistic infections and neoplasias.
Measured: 12 months
Proportion of patients with haematological disorders
The proportion of patients with haematological disorders (neutropenia, anaemia, thrombopenia)
Measured: 12 months
Proportion of patients with diarrhea
Measured: 12 months
Proportion of dyslipidemia
Measured: 12 months
Proportion of patients with occurrence of New Onset Diabetes Mellitus as defined by American Diabetic Association (ADA) criteria.
Measured: 12 months
Proportion of patients who will discontinue the immunosuppressive treatment and the reasons why.
Measured: 12 months
Proportion of patients with delayed graft function
Measured: 12 months
Proportion of lymphocele
Measured: 12 months
Time to the first CMV DNAemia
Measured: Throughout the study

Timeline

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

2 May 201410 Oct 2018

First posted31 Dec 2014 (estimated)
Study start2 May 2014
Primary completion10 Oct 2018
Study completion10 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Transplantation InfectionStudies of the same condition, open and under way.
More trials run by University Hospital, BordeauxThe 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: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02328963
Sponsor's protocol ID: CHUBX2012/29
Acronym: EVERCMV
Status last verified: Nov 2018
First submitted: 1 Sep 2014
Last updated: 27 Jul 2026
Results posted: No
Data monitoring committee: Yes

Publications

Kaminski H, Marseres G, Yared N, Nokin MJ, Pitard V, Zouine A, Garrigue I, Loizon S, Capone M, Gauthereau X, Mamani-Matsuda M, Coueron R, Duran RV, Pinson B, Pellegrin I, Thiebaut R, Couzi L, Merville P, Dechanet-Merville J. mTOR Inhibitors Prevent CMV Infection through the Restoration of Functional alphabeta and gammadelta T cells in Kidney Transplantation. J Am Soc Nephrol. 2022 Jan;33(1):121-137. doi: 10.1681/ASN.2020121753. Epub 2021 Nov 1.
PubMed 34725108
Kaminski H, Kamar N, Thaunat O, Bouvier N, Caillard S, Garrigue I, Anglicheau D, Rerolle JP, Le Meur Y, Durrbach A, Bachelet T, Savel H, Coueron R, Visentin J, Del Bello A, Pellegrin I, Dechanet-Merville J, Merville P, Thiebaut R, Couzi L. Incidence of cytomegalovirus infection in seropositive kidney transplant recipients treated with everolimus: A randomized, open-label, multicenter phase 4 trial. Am J Transplant. 2022 May;22(5):1430-1441. doi: 10.1111/ajt.16946. Epub 2022 Jan 19.
PubMed 34990047

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

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Two Arms, Randomized, Open Label Clinical Phase IV Study Investigating the Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection Within the First 6 Months Post-transplantation When Treated With an Immunosuppressive Regimen Including Everolimus (Certican®) and Reduced Dose of Cyclosporine A (Neoral®) Versus an Immunosuppressive Regimen With Mycophenolic Acid (Myfortic®) and Standard Dose of Cyclosporine A (Neoral®).
ClinicalTrials.gov ID: NCT02328963
Acronym / sponsor ID: EVERCMV / CHUBX2012/29
Conditions: Transplantation Infection, Cytomegalovirus Infection
Keywords: Cytomegalovirus infection and disease, CMV-seropositive recipients, Everolimus, preemptive strategy, mTOR inhibitor
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 186 participants (actual)
Lead sponsor: University Hospital, BordeauxUniversity, hospital or other
Collaborators: Novartis
Study start: 2 May 2014 (actual)
Primary completion: 10 Oct 2018 (actual)
Study completion: 10 Oct 2018 (actual)
First posted: 31 Dec 2014 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Everolimus	Experimental	Drug: EverolimusEverolimus + reduced dose of cyclosporine A
mycophenolic acid	Active comparator	Drug: mycophenolic acidmycophenolic acid + standard dose of cyclosporin A

Who may qualify

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

Key inclusion criteria (9 listed)

Age ≥ 18 years.
End stage kidney disease and a suitable candidate for primary renal transplantation or re-transplantation.
Patient seropositive for CMV (confirmed within two weeks post-transplant) and having received an allograft from a CMV seropositive or seronegative donor.
Receiving a kidney transplant from a deceased or living donor with compatible ABO blood type.
Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study and two months later the discontinuation of the test drug.

Key exclusion criteria (18 listed)

CMV seronegative patient.
Historical or current TGI (French equivalence of calculated PRA) > 85 %
Presence of historical or current anti-HLA donor specific antibodies
Patient who received anti-CMV therapy within the past 30 days prior to screening.
Receiving or having previously received an organ transplant other than a kidney.

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
EverolimusEverolimus : 0.75 bid, targeted to 3-8 ng/ml Cyclosporin A : CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12. Corticosteroids : Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study Basiliximab :Day 0: 20 mg ; Day 4: 20 mg	Drug	Everolimus
mycophenolic acidMycophenolic acid : 1080 mg bid for one month, then 720 mg bid Cyclosporin A : CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12. Corticosteroids : Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study Basiliximab :Day 0: 20 mg ; Day 4: 20 mg	Drug	mycophenolic acid

Primary outcome

Number of participants without CMV infection and without graft loss in CMV seropositive kidney transplant recipients.
Time frame: 6 months post-transplantation
The primary objective of this study is to compare the survival without CMV infection and without graft loss in CMV seropositive kidney transplant recipients, within the first 6 months post-transplantation when treated with an immunosuppressive regimen including everolimus (Certican®) and reduced dose (RD) of cyclosporine A (Néoral®) versus an immunosuppressive regimen with mycophenolic acid (Myfortic®) and standard dose (SD) of cyclosporine A (Néoral®).

23 secondary outcomes

Proportion of patients who will develop CMV disease
Time frame: 6 and 12 months post-transplantation
Proportion of patient with graft loss, death and loss of follow-up
Time frame: 12 months post-transplantation
Proportion of patient with acute rejection, graft loss, death and loss of follow-u
Time frame: 12 months
Level to the first CMV DNAemia
Time frame: Throughout the study
Time to the first CMV disease
Time frame: Throughout the study
Proportion of patients treated for CMV infection in both groups
Time frame: 6 months
Half-life of decreasing of DNAemia
Time frame: after initiation of anti-CMV therapy
Occurrence of treatment failure, defined as the absence of viral eradication.
Time frame: Day 49 (or 8 weeks) after the initiation of anti-CMV therapy
Occurrence of CMV mutation (UL97 ou UL54) associated with a resistance to an anti-CMV therapy.
Time frame: Throughout the study
Graft function
Time frame: 6 and 12 months post-transplantation
Proportion of patients with biopsy-proven acute rejection (BPAR)
Time frame: 6 and 12 months post-transplantation
Degree of interstitial fibrosis/tubular atrophy
Time frame: 12 months on protocol biopsies
Graft and patient survival
Time frame: 6 and 12 months post-transplantation
Proportion of BK virus viremia
Time frame: month 1, 3, 6 and 12
Proportion of patients with adverse events (AE) and/or serious adverse events (SAE) including opportunistic infections and neoplasias.
Time frame: 12 months
Proportion of patients with haematological disorders
Time frame: 12 months
Proportion of patients with diarrhea
Time frame: 12 months
Proportion of dyslipidemia
Time frame: 12 months
Proportion of patients with occurrence of New Onset Diabetes Mellitus as defined by American Diabetic Association (ADA) criteria.
Time frame: 12 months
Proportion of patients who will discontinue the immunosuppressive treatment and the reasons why.
Time frame: 12 months
Proportion of patients with delayed graft function
Time frame: 12 months
Proportion of lymphocele
Time frame: 12 months
Time to the first CMV DNAemia
Time frame: Throughout the study

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
Results publication: PubMed 34725108Kaminski H, Marseres G, Yared N, Nokin MJ, Pitard V, Zouine A, Garrigue I, Loizon S, Capone M, Gauthereau X, Mamani-Matsuda M, Coueron R, Duran RV, Pinson B, Pellegrin I, Thiebaut R, Couzi L, Merville P, Dechanet-Merville J. mTOR Inhibitors Prevent CMV Infection through the Restoration of Functional alphabeta and gammadelta T cells in Kidney Transplantation. J Am Soc Nephrol. 2022 Jan;33(1):121-137. doi: 10.1681/ASN.2020121753. Epub 2021 Nov 1.
Results publication: PubMed 34990047Kaminski H, Kamar N, Thaunat O, Bouvier N, Caillard S, Garrigue I, Anglicheau D, Rerolle JP, Le Meur Y, Durrbach A, Bachelet T, Savel H, Coueron R, Visentin J, Del Bello A, Pellegrin I, Dechanet-Merville J, Merville P, Thiebaut R, Couzi L. Incidence of cytomegalovirus infection in seropositive kidney transplant recipients treated with everolimus: A randomized, open-label, multicenter phase 4 trial. Am J Transplant. 2022 May;22(5):1430-1441. doi: 10.1111/ajt.16946. Epub 2022 Jan 19.

Related trials for Transplantation Infection

RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
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RecruitingPhase 2
Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
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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.

Lionel COUZI, MD principal investigator

University Hospital, Bordeaux

Rodolphe THIEBAUT, MD, PhD study chair

University Hospital, Bordeaux

9 sites 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 mycophenolic acid in people with Transplantation Infection and Cytomegalovirus Infection, run by University Hospital, Bordeaux at 9 sites in France.

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 9 inclusion and 18 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of participants without CMV infection and without graft loss in CMV seropositive kidney transplant recipients. (time frame: 6 months post-transplantation). 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 NCT02328963, which also lists 2 linked publications.

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 27 Jul 2026.