CMV InfectionPhase 3NCT06341686
Evaluation of the Prophylactic Use of Letermovir in Kidney Transplant Recipients at Risk of Cytomegalovirus Infection
A Phase 3 study testing Letermovir 480 MG and Ganciclovir in people with CMV Infection, run by Hospital do Rim e Hipertensão.
Trial summary
The two main cytomegalovirus (CMV) prevention strategies are prophylaxis and preemptive therapy. Prophylaxis effectively prevents CMV infection after solid organ transplantation (SOT), but is associated with high rates of neutropenia and late onset of post-prophylactic disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMV Infection
- What is being tested?
- Letermovir 480 MG and Ganciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2024to May 2025
- Phase
- Phase 3
- 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
- Kidney transplant or re-transplant recipients, aged ≥18 years;
- Undergoing induction therapy with anti-thymocyte globulin;
- Receiving maintenance treatment with Tacrolimus, Mycophenolate and Prednisone;
- Positive CMV serology for donor and recipient.
Who cannot join
- CMV serology positive for donor and negative for recipient;
- Multiple organ recipients, or other organs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Prophylactic Use of Letermovir Versus Preemptive Strategy in Kidney Transplant Recipients at Higher Risk of Cytomegalovirus Infection: a Prospective Randomized Study
The two main cytomegalovirus (CMV) prevention strategies are prophylaxis and preemptive therapy. Prophylaxis effectively prevents CMV infection after solid organ transplantation (SOT), but is associated with high rates of neutropenia and late onset of post-prophylactic disease. In contrast, preemptive therapy has the advantage of leading to lower rates of CMV disease and robust humoral and T-cell responses. It is widely used in hematopoietic cell transplant recipients, but is rarely used after solid organ transplant recipients due to logistical considerations.
Read the detailed description
Oral Letermovir for 84 days is effective in the prophylaxis of CMV infection in high-risk kidney transplant recipients. Oral Letermovir for 84 days, is associated with a lower incidence of CMV infection in high-risk high-risk kidney transplant recipients. In addition, the use of Letermovir is safe and associated with a low incidence of CMV syndrome or disease up to 6 months after after kidney transplantation. Finally, prophylaxis with Letermovir is associated with a lower incidence of discontinuation of immunosuppressive drugs, reducing the risk of of clinical and subclinical acute rejection
- Conditions
- CMV Infection
- Being tested
- Letermovir 480 MG, Ganciclovir
- Keywords
- Cytomegalovirus, Letermovir, Kidney transplant
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letermovir 480 MGDrug
Oral Letermovir for 84 days is effective in the prophylaxis of CMV infection in high-risk kidney transplant recipients. Oral Letermovir for 84 days, is associated with a lower incidence of CMV infection in high-risk high-risk kidney transplant recipients. In addition, the use of Letermovir is safe and associated with a low incidence of CMV syndrome or disease up to 6 months after after kidney transplantation. Finally, prophylaxis with Letermovir is associated with a lower incidence of discontinuation of immunosuppressive drugs, reducing the risk of of clinical and subclinical acute rejection
GanciclovirDrug
The threshold for starting treatment with Ganciclovir is a CMV DNAemia > 5,000 IU in a single measurement (CMV infection) measurement (CMV infection) OR any CMV DNAemia with any signs or symptoms associated with CMV (syndrome or disease).
| Study group | Role | What they receive |
|---|---|---|
| Letermovir | Experimental | Patients randomized to the prophylaxis group: Letermovir 480mg, 1x/day, from D14 to D98. Letermovir prophylaxis will start on day 14 after kidney transplantation. In both groups, CMV DNAemia will be monitored weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98), and after any acute rejection treatment occurring between 3 months and 6 months after kidney transplantation. Receives: Drug: Letermovir 480 MG |
| Preemptive therapy | Active comparator | Patients randomized to the preemptive treatment group:
Preemptive treatment (PET) will begin on day 21, assessing CMV DNAnemia weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 e 98). The threshold for starting treatment with Ganciclovir is a CMV DNAemia > 5,000 IU in a single measurement (CMV infection). measurement (CMV infection) OR any CMV DNAemia with any signs or symptoms associated with CMV (syndrome or disease).c. In both groups, CMV DNAemia will be monitored weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98), and after any acute rejection treatment occurring between 3 months and 6 months after kidney transplantation. Receives: Drug: Ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CMV syndrome or disease
Proportion (%) of CMV syndrome or disease
Measured: 6 months after transplantation
Secondary outcomes (2)
Incidence of patients with plasma CMV DNAemia > 200 IU
Proportion (%) of patients with plasma CMV DNAemia > 200 IU
Measured: 3 months
Incidence of patients with CMV infection/syndrome/disease
Proportion (%) of patients with CMV infection/syndrome/disease
Measured: 84 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start5 May 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CMV 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Patients randomized to the prophylaxis group: Letermovir 480mg, 1x/day, from D14 to D98. Letermovir prophylaxis will start on day 14 after the kidney transplant. 2. Patients randomized to the preemptive treatment group: Preemptive treatment (PET) will begin on day 21, evaluating CMV DNAnemia weekly until D98.CMV DNAnemia weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98). The threshold for starting treatment with Ganciclovir is a CMV DNAemiaDNAemia \> 5,000 IU in a single measurement (CMV infection) OR any CMV DNAemia with any signs or symptoms associated with CMV (CMV syndrome or disease). 3. In both groups, CMV DNAemia will be monitored weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98), and after any acute rejection treatment occurring between 3 months and 6 months after kidney transplantation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Rim e Hipertensão
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helio Tedesco Silva Junior, Hospital do Rim e Hipertensão
- Investigators
- Helio Tedesco, Principal investigator, Doctor of Renal Transplant Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341686
- Sponsor's protocol ID
- 75471023.2.0000.0082
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191.
PubMed 29596116Henrique Pinto C, Tedesco-Silva H Jr, Rosso Felipe C, Nicolau Ferreira A, Cristelli M, Almeida Viana L, Aguiar W, Medina-Pestana J. Targeted preemptive therapy according to perceived risk of CMV infection after kidney transplantation. Braz J Infect Dis. 2016 Nov-Dec;20(6):576-584. doi: 10.1016/j.bjid.2016.08.007. Epub 2016 Sep 25.
PubMed 27643978de Paula MI, Bae S, Shaffer AA, Garonzik-Wang J, Felipe CR, Cristelli MP, Waldram MM, Massie AB, Medina-Pestana J, Segev DL, Tedesco-Silva H. The Influence of Antithymocyte Globulin Dose on the Incidence of CMV Infection in High-risk Kidney Transplant Recipients Without Pharmacological Prophylaxis. Transplantation. 2020 Oct;104(10):2139-2147. doi: 10.1097/TP.0000000000003124.
PubMed 31978003Felipe C, Ferreira AN, de Paula M, Viana L, Cristelli M, Medina Pestana J, Tedesco-Silva H. Incidence and risk factors associated with cytomegalovirus infection after the treatment of acute rejection during the first year in kidney transplant recipients receiving preemptive therapy. Transpl Infect Dis. 2019 Dec;21(6):e13106. doi: 10.1111/tid.13106. Epub 2019 Oct 29.
PubMed 31081566Felipe CR, Ferreira AN, Bessa A, Abait T, Ruppel P, Paula MI, Hiramoto L, Viana L, Martins S, Cristelli M, Aguiar W, Mansur J, Basso G, Silva Junior HT, Pestana JM. The current burden of cytomegalovirus infection in kidney transplant recipients receiving no pharmacological prophylaxis. J Bras Nefrol. 2017 Oct-Dec;39(4):413-423. doi: 10.5935/0101-2800.20170074. English, Portuguese.
PubMed 29319768Haidar G, Boeckh M, Singh N. Cytomegalovirus Infection in Solid Organ and Hematopoietic Cell Transplantation: State of the Evidence. J Infect Dis. 2020 Mar 5;221(Suppl 1):S23-S31. doi: 10.1093/infdis/jiz454.
PubMed 32134486Ljungman P, Boeckh M, Hirsch HH, Josephson F, Lundgren J, Nichols G, Pikis A, Razonable RR, Miller V, Griffiths PD; Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials. Clin Infect Dis. 2017 Jan 1;64(1):87-91. doi: 10.1093/cid/ciw668. Epub 2016 Sep 28.
PubMed 27682069Chemaly RF, Chou S, Einsele H, Griffiths P, Avery R, Razonable RR, Mullane KM, Kotton C, Lundgren J, Komatsu TE, Lischka P, Josephson F, Douglas CM, Umeh O, Miller V, Ljungman P; Resistant Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials. Clin Infect Dis. 2019 Apr 8;68(8):1420-1426. doi: 10.1093/cid/ciy696.
PubMed 30137245
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Prophylactic Use of Letermovir Versus Preemptive Strategy in Kidney Transplant Recipients at Higher Risk of Cytomegalovirus Infection: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06341686
- Acronym / sponsor ID
- 75471023.2.0000.0082
- Conditions
- CMV Infection
- Keywords
- Cytomegalovirus, Letermovir, Kidney transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital do Rim e HipertensãoUniversity, hospital or other
- Study start
- 5 May 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 2 Apr 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.
The two main cytomegalovirus (CMV) prevention strategies are prophylaxis and preemptive therapy. Prophylaxis effectively prevents CMV infection after solid organ transplantation (SOT), but is associated with high rates of neutropenia and late onset of post-prophylactic disease. In contrast, preemptive therapy has the advantage of leading to lower rates of CMV disease and robust humoral and T-cell responses. It is widely used in hematopoietic cell transplant recipients, but is rarely used after solid organ transplant recipients due to logistical considerations.
Detailed description
Oral Letermovir for 84 days is effective in the prophylaxis of CMV infection in high-risk kidney transplant recipients. Oral Letermovir for 84 days, is associated with a lower incidence of CMV infection in high-risk high-risk kidney transplant recipients. In addition, the use of Letermovir is safe and associated with a low incidence of CMV syndrome or disease up to 6 months after after kidney transplantation. Finally, prophylaxis with Letermovir is associated with a lower incidence of discontinuation of immunosuppressive drugs, reducing the risk of of clinical and subclinical acute rejection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1. Patients randomized to the prophylaxis group: Letermovir 480mg, 1x/day, from D14 to D98. Letermovir prophylaxis will start on day 14 after the kidney transplant. 2. Patients randomized to the preemptive treatment group: Preemptive treatment (PET) will begin on day 21, evaluating CMV DNAnemia weekly until D98.CMV DNAnemia weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98). The threshold for starting treatment with Ganciclovir is a CMV DNAemiaDNAemia > 5,000 IU in a single measurement (CMV infection) OR any CMV DNAemia with any signs or symptoms associated with CMV (CMV syndrome or disease). 3. In both groups, CMV DNAemia will be monitored weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98), and after any acute rejection treatment occurring between 3 months and 6 months after kidney transplantation.
| Arm | Type | Receives |
|---|---|---|
| Letermovir | Experimental | Drug: Letermovir 480 MGPatients randomized to the prophylaxis group: Letermovir 480mg, 1x/day, from D14 to D98. Letermovir prophylaxis will start on day 14 after kidney transplantation. In both groups, CMV DNAemia will be monitored weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98), and after any acute rejection treatment occurring between 3 months and 6 months after kidney transplantation. |
| Preemptive therapy | Active comparator | Drug: GanciclovirPatients randomized to the preemptive treatment group: Preemptive treatment (PET) will begin on day 21, assessing CMV DNAnemia weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 e 98). The threshold for starting treatment with Ganciclovir is a CMV DNAemia > 5,000 IU in a single measurement (CMV infection). measurement (CMV infection) OR any CMV DNAemia with any signs or symptoms associated with CMV (syndrome or disease).c. In both groups, CMV DNAemia will be monitored weekly until day 98 (21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91 and 98), and after any acute rejection treatment occurring between 3 months and 6 months after kidney transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Kidney transplant or re-transplant recipients, aged ≥18 years;
- Undergoing induction therapy with anti-thymocyte globulin;
- Receiving maintenance treatment with Tacrolimus, Mycophenolate and Prednisone;
- Positive CMV serology for donor and recipient.
Key exclusion criteria (2 listed)
- CMV serology positive for donor and negative for recipient;
- Multiple organ recipients, or other organs
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 |
|---|---|---|
| Letermovir 480 MGOral Letermovir for 84 days is effective in the prophylaxis of CMV infection in high-risk kidney transplant recipients. Oral Letermovir for 84 days, is associated with a lower incidence of CMV infection in high-risk high-risk kidney transplant recipients. In addition, the use of Letermovir is safe and associated with a low incidence of CMV syndrome or disease up to 6 months after after kidney transplantation. Finally, prophylaxis with Letermovir is associated with a lower incidence of discontinuation of immunosuppressive drugs, reducing the risk of of clinical and subclinical acute rejection | Drug | Letermovir |
| GanciclovirThe threshold for starting treatment with Ganciclovir is a CMV DNAemia > 5,000 IU in a single measurement (CMV infection) measurement (CMV infection) OR any CMV DNAemia with any signs or symptoms associated with CMV (syndrome or disease). | Drug | Preemptive therapy |
Primary outcome
Incidence of CMV syndrome or disease
Time frame: 6 months after transplantation
Proportion (%) of CMV syndrome or disease
2 secondary outcomes
Incidence of patients with plasma CMV DNAemia > 200 IU
Time frame: 3 months
Incidence of patients with CMV infection/syndrome/disease
Time frame: 84 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 29596116Kotton CN, Kumar D, Caliendo AM, Huprikar S, Chou S, Danziger-Isakov L, Humar A; The Transplantation Society International CMV Consensus Group. The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation. Transplantation. 2018 Jun;102(6):900-931. doi: 10.1097/TP.0000000000002191.
- Background: PubMed 27643978Henrique Pinto C, Tedesco-Silva H Jr, Rosso Felipe C, Nicolau Ferreira A, Cristelli M, Almeida Viana L, Aguiar W, Medina-Pestana J. Targeted preemptive therapy according to perceived risk of CMV infection after kidney transplantation. Braz J Infect Dis. 2016 Nov-Dec;20(6):576-584. doi: 10.1016/j.bjid.2016.08.007. Epub 2016 Sep 25.
- Results publication: PubMed 31978003de Paula MI, Bae S, Shaffer AA, Garonzik-Wang J, Felipe CR, Cristelli MP, Waldram MM, Massie AB, Medina-Pestana J, Segev DL, Tedesco-Silva H. The Influence of Antithymocyte Globulin Dose on the Incidence of CMV Infection in High-risk Kidney Transplant Recipients Without Pharmacological Prophylaxis. Transplantation. 2020 Oct;104(10):2139-2147. doi: 10.1097/TP.0000000000003124.
- Results publication: PubMed 31081566Felipe C, Ferreira AN, de Paula M, Viana L, Cristelli M, Medina Pestana J, Tedesco-Silva H. Incidence and risk factors associated with cytomegalovirus infection after the treatment of acute rejection during the first year in kidney transplant recipients receiving preemptive therapy. Transpl Infect Dis. 2019 Dec;21(6):e13106. doi: 10.1111/tid.13106. Epub 2019 Oct 29.
- Results publication: PubMed 29319768Felipe CR, Ferreira AN, Bessa A, Abait T, Ruppel P, Paula MI, Hiramoto L, Viana L, Martins S, Cristelli M, Aguiar W, Mansur J, Basso G, Silva Junior HT, Pestana JM. The current burden of cytomegalovirus infection in kidney transplant recipients receiving no pharmacological prophylaxis. J Bras Nefrol. 2017 Oct-Dec;39(4):413-423. doi: 10.5935/0101-2800.20170074. English, Portuguese.
- Results publication: PubMed 32134486Haidar G, Boeckh M, Singh N. Cytomegalovirus Infection in Solid Organ and Hematopoietic Cell Transplantation: State of the Evidence. J Infect Dis. 2020 Mar 5;221(Suppl 1):S23-S31. doi: 10.1093/infdis/jiz454.
- Results publication: PubMed 27682069Ljungman P, Boeckh M, Hirsch HH, Josephson F, Lundgren J, Nichols G, Pikis A, Razonable RR, Miller V, Griffiths PD; Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials. Clin Infect Dis. 2017 Jan 1;64(1):87-91. doi: 10.1093/cid/ciw668. Epub 2016 Sep 28.
- Results publication: PubMed 30137245Chemaly RF, Chou S, Einsele H, Griffiths P, Avery R, Razonable RR, Mullane KM, Kotton C, Lundgren J, Komatsu TE, Lischka P, Josephson F, Douglas CM, Umeh O, Miller V, Ljungman P; Resistant Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials. Clin Infect Dis. 2019 Apr 8;68(8):1420-1426. doi: 10.1093/cid/ciy696.
- Individual participant dataSharing planned: No
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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.
Helio Tedesco principal investigator
Doctor of Renal Transplant Unit
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letermovir 480 MG and Ganciclovir in people with CMV Infection, run by Hospital do Rim e Hipertensão.
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 4 inclusion and 2 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 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Hélio Tedesco (+55 11 5087 8113, heliotedesco@medfarm.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CMV syndrome or disease (time frame: 6 months after 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 NCT06341686, which also lists 8 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 2 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.