Renal Transplant RecipientsNCT02973464
The Strategy in the Prevention of Renal Post-transplant Cytomegalovirus Infection Among Chinese Population
An observational study of Renal Transplant Recipients, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study evaluates the safety and availability of oral valganciclovir(VGC) at the does of 450mg daily begin within 10 days after renal transplantation, and till to Day 100 posttransplant. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Renal Transplant Recipients
- What is being tested?
- Valganciclovir and Ganciclovir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Renal Transplant Recipients
Who may be able to join
- 1.65 years old>=Age>=18 years old, male or female
- 2.Renal transplantation first time
- 3.CMV serology donor-positive(D+) or recipient-positive(R+) renal transplant recipients
Who cannot join
- 1.Those who are allergic or resistant to Acyclovir, Valaciclovir, Ganciclovir, Valganciclovir
- 2.HIV, hepatitis B or hepatitis C patients
- 3.Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnancy during treatment
- 4.Male with a pregnant partner; or lactation
- 5.Suspected CMV disease at enrolment
- 6.Use of anti-CMV therapy within 30 days prior to study
Show all 9Show fewer
- 7.Multiple organ transplantation
- 8.Uncontrolled diarrhea or evidence of malabsorption
- 9.Liver function tests>3 times the upper level of normal
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Xiaoming D Ding, PhD, xmding@mail.xju.edu.cn
About this study
This study evaluates the safety and availability of oral valganciclovir(VGC) at the does of 450mg daily begin within 10 days after renal transplantation, and till to Day 100 posttransplant. Compare to the guidelines for effective antiviral prophylaxis, the investigators divide these patients into three groups in random. One third will oral VGC 450mg daily as mentioned above; one third will oral VGC 900mg daily; and the other one third will intravenous GCV 5mg/kg daily within the first 14 days posttransplant, and continue to oral GCV 1g 3 times daily till to Day 100 posttransplant; with does adjusted per renal function for all agents.
Read the detailed description
Human Cytomegalovirus(CMV), a kind of β-hepersvirus, which is a common opportunistic pathogen. The ubiquity of CMV infection in human beings had been verified; and the CMV-IgG seropositive rate is 97% among healthy population, most of them are at the state of latent infection. When immunosuppressed, such as for renal transplant recipients, the incidence of CMV infection and disease increase obviously. The posttransplant CMV infection would induce allgraft rejection, impact on allgraft and recipients survival, as well as contribute to the serious complications.Many studies show that giving effective antivirus drugs after transplantation is benifit to recipients.
Nowadays,the strategy of intravenous GCV GCV 5mg/kg daily or oral GCV 1g 3 times daily, which is the recommended treatment for CMV disease posttransplantation.Resent date show that VGC is an oral prodrug of GCV. When VGC is absorbed in the intestinal wall and liver, it is rapidly metabolized to ganciclovir. As a contemporary study, IV GCV 5mg/kg/day will approach to a similar area under the curve to VGC 900mg daily. The bioavailability of ganciglovir from valganciclovir is 10 times of GCV by oral. For recipients, oral therapy is more safety and convinient, so that it will reduce frequent hospitalizations. As many researches, it is indicated that oral VGC 450mg daily can also reduce the adverse events resulting from posttransplant CMV infection, there is no significantly statistic differences when compared with oral VGC 900mg daily. Simultaneously, lower dose could decrease the risk of leukopenia and ease the burden for recipients.
This study is a single-center, prospective, observational, corhort study. According to the inclusion and exclusion criteria, the investigators will recruit 450 patients. And every one will be followed up for at least 12 months unless death or graft loss, the specific duration is at baseline, weekly within the first 3 months posttransplantation, month 4, month 5, month 6, month 9, and month 12. Recipients will be followed for CMV-DNA, CMV-pp65, CMV antigenemia, blood routine test, urinalysis, liver function, renal fuction and the chest X-ray films. Inverstigators should collect the date of recipient as below: general conditions, such as age, sex, weight and so on; primary reason for transplant; donor/recipient CMV serostatus; biopsy-prove acute rejection; opportunistic infections; NODAT; etc. And Chi-square or Fisher's exact test will be used as appropriate to compare categorical variables, and it is considered as statistically significant when the 2-sided P-value<0.05. Definitively, conclusion will be come out to verify the safety and availability of our protocol.
- Conditions
- Renal Transplant Recipients
- Being tested
- Valganciclovir, Ganciclovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
Also called Valcyte, Valin ganciclovir, VGC
Oral at a dose of 450mg or 900mg per day begin within 10 days till to Day 100 posttransplant
GanciclovirDrug
Also called Cymevene, GCV
intravenous GCV 5mg/kg/d after renal transplantation for the first 14 days, and then oral GCV 1g 3 times daily till to Day 100 posttransplant.
| Study group | Role | What they receive |
|---|---|---|
| Valganciclovir 900mg a day | Valganciclovir 900mg tablet by mouth begin within 10 days after renal transplant，once a day till to Day 100 posttransplant. Receives: Drug: Valganciclovir | |
| Valganciclovir 450mg a day | Valgancigclovir 450 mg tablet by mouth begin within 10 days after renal transplant，once a day till to Day 100 posttransplant. Receives: Drug: Valganciclovir | |
| Ganciclovir | Ganciclovir 5mg/kg fluids by intravenous after renal transplant，once a day for the first 14 days；and than sequential Ganciclovir 1g tablet by mouth，third a day till to Day 100 posttransplant. Receives: Drug: Ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of CMV infection and disease
Measured: within the first 1 year after renal transplant
Secondary outcomes (6)
incidence of CMV infection and disease
Measured: within the first 3 and 6 months after renal transplant respectively
GCV-resistant CMV infection
Measured: within the first 1 year after renal transplant
mean estimated renal function, allograft survival and patient survival
Measured: within the first 1 year after renal transplant
incidence of acute rejection
Measured: within the first 1 year after renal transplant
other opportunistic infections
Measured: within the first 1 year after renal transplant
adverse events, such as NODAT
Measured: within the first 1 year after renal transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant RecipientsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Xiaoming, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Xiaoming D Ding, PhD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973464
- Sponsor's protocol ID
- XJTU1AF2016LSK-25
- Status last verified
- Dec 2016
- First submitted
- 22 Nov 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Tomasec P, Braud VM, Rickards C, Powell MB, McSharry BP, Gadola S, Cerundolo V, Borysiewicz LK, McMichael AJ, Wilkinson GW. Surface expression of HLA-E, an inhibitor of natural killer cells, enhanced by human cytomegalovirus gpUL40. Science. 2000 Feb 11;287(5455):1031. doi: 10.1126/science.287.5455.1031.
PubMed 10669413Retiere C, Prod'homme V, Imbert-Marcille BM, Bonneville M, Vie H, Hallet MM. Generation of cytomegalovirus-specific human T-lymphocyte clones by using autologous B-lymphoblastoid cells with stable expression of pp65 or IE1 proteins: a tool to study the fine specificity of the antiviral response. J Virol. 2000 May;74(9):3948-52. doi: 10.1128/jvi.74.9.3948-3952.2000.
PubMed 10756006Zheng Q, Tao R, Gao H, Xu J, Shang S, Zhao N. HCMV-encoded UL128 enhances TNF-alpha and IL-6 expression and promotes PBMC proliferation through the MAPK/ERK pathway in vitro. Viral Immunol. 2012 Apr;25(2):98-105. doi: 10.1089/vim.2011.0064.
PubMed 22486303Rubin RH. Infectious disease complications of renal transplantation. Kidney Int. 1993 Jul;44(1):221-36. doi: 10.1038/ki.1993.234. No abstract available.
PubMed 8394951Schmaldienst S, Horl WH. Bacterial infections after renal transplantation. Nephron. 1997;75(2):140-53. doi: 10.1159/000189523. No abstract available.
PubMed 9041533Streblow DN, Orloff SL, Nelson JA. Acceleration of allograft failure by cytomegalovirus. Curr Opin Immunol. 2007 Oct;19(5):577-82. doi: 10.1016/j.coi.2007.07.012. Epub 2007 Aug 22.
PubMed 17716883Szczepura A, Westmoreland D, Vinogradova Y, Fox J, Clark M. Evaluation of molecular techniques in prediction and diagnosis of cytomegalovirus disease in immunocompromised patients. Health Technol Assess. 2006 Apr;10(10):1-176. doi: 10.3310/hta10100.
PubMed 16595079Bendiksen S, Van Ghelue M, Rekvig OP, Gutteberg T, Haga HJ, Moens U. A longitudinal study of human cytomegalovirus serology and viruria fails to detect active viral infection in 20 systemic lupus erythematosus patients. Lupus. 2000;9(2):120-6. doi: 10.1191/096120300678828118.
PubMed 10787009Zhou L, Fan J, Zheng SS, Ma WH. Prevalence of human cytomegalovirus UL97 D605E mutation in transplant recipients in China. Transplant Proc. 2006 Nov;38(9):2926-8. doi: 10.1016/j.transproceed.2006.08.161.
PubMed 17112867Dong B, Wang Y, Wang G, Wang W, Zhou H, Fu Y. A retrospective study of cytomegalovirus pneumonia in renal transplant patients. Exp Ther Med. 2014 May;7(5):1111-1115. doi: 10.3892/etm.2014.1577. Epub 2014 Feb 24.
PubMed 24940395Meije Y, Fortun J, Len O, Aguado JM, Moreno A, Cisneros JM, Gurgui M, Carratala J, Munoz P, Montejo M, Blanes M, Bou G, Perez JL, Torre-Cisneros J, Ramos A, Pahissa A, Gavalda J; Spanish Network for Research on Infection in Transplantation (RESITRA) and the Spanish Network for Research on Infectious Diseases (REIPI). Prevention strategies for cytomegalovirus disease and long-term outcomes in the high-risk transplant patient (D+/R-): experience from the RESITRA-REIPI cohort. Transpl Infect Dis. 2014 Jun;16(3):387-96. doi: 10.1111/tid.12226. Epub 2014 May 8.
PubMed 24807640Fernandez-Ruiz M, Arias M, Campistol JM, Navarro D, Gomez-Huertas E, Gomez-Marquez G, Diaz JM, Hernandez D, Bernal-Blanco G, Cofan F, Jimeno L, Franco-Esteve A, Gonzalez E, Moreso FJ, Gomez-Alamillo C, Mendiluce A, Luna-Huerta E, Aguado JM; OPERA Study Group. Cytomegalovirus prevention strategies in seropositive kidney transplant recipients: an insight into current clinical practice. Transpl Int. 2015 Sep;28(9):1042-54. doi: 10.1111/tri.12586. Epub 2015 Apr 23.
PubMed 25864986Khoury JA, Storch GA, Bohl DL, Schuessler RM, Torrence SM, Lockwood M, Gaudreault-Keener M, Koch MJ, Miller BW, Hardinger KL, Schnitzler MA, Brennan DC. Prophylactic versus preemptive oral valganciclovir for the management of cytomegalovirus infection in adult renal transplant recipients. Am J Transplant. 2006 Sep;6(9):2134-43. doi: 10.1111/j.1600-6143.2006.01413.x. Epub 2006 Jun 19.
PubMed 16780548Asberg A, Humar A, Rollag H, Jardine AG, Mouas H, Pescovitz MD, Sgarabotto D, Tuncer M, Noronha IL, Hartmann A; VICTOR Study Group. Oral valganciclovir is noninferior to intravenous ganciclovir for the treatment of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant. 2007 Sep;7(9):2106-13. doi: 10.1111/j.1600-6143.2007.01910.x. Epub 2007 Jul 19.
PubMed 17640310Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.
PubMed 20353469
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Strategy in the Prevention of Renal Post-transplant Cytomegalovirus Infection Among Chinese Population
- ClinicalTrials.gov ID
- NCT02973464
- Acronym / sponsor ID
- XJTU1AF2016LSK-25
- Conditions
- Renal Transplant Recipients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 25 Nov 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.
This study evaluates the safety and availability of oral valganciclovir(VGC) at the does of 450mg daily begin within 10 days after renal transplantation, and till to Day 100 posttransplant. Compare to the guidelines for effective antiviral prophylaxis, the investigators divide these patients into three groups in random. One third will oral VGC 450mg daily as mentioned above; one third will oral VGC 900mg daily; and the other one third will intravenous GCV 5mg/kg daily within the first 14 days posttransplant, and continue to oral GCV 1g 3 times daily till to Day 100 posttransplant; with does adjusted per renal function for all agents.
Detailed description
Human Cytomegalovirus(CMV), a kind of β-hepersvirus, which is a common opportunistic pathogen. The ubiquity of CMV infection in human beings had been verified; and the CMV-IgG seropositive rate is 97% among healthy population, most of them are at the state of latent infection. When immunosuppressed, such as for renal transplant recipients, the incidence of CMV infection and disease increase obviously. The posttransplant CMV infection would induce allgraft rejection, impact on allgraft and recipients survival, as well as contribute to the serious complications.Many studies show that giving effective antivirus drugs after transplantation is benifit to recipients.
Nowadays,the strategy of intravenous GCV GCV 5mg/kg daily or oral GCV 1g 3 times daily, which is the recommended treatment for CMV disease posttransplantation.Resent date show that VGC is an oral prodrug of GCV. When VGC is absorbed in the intestinal wall and liver, it is rapidly metabolized to ganciclovir. As a contemporary study, IV GCV 5mg/kg/day will approach to a similar area under the curve to VGC 900mg daily. The bioavailability of ganciglovir from valganciclovir is 10 times of GCV by oral. For recipients, oral therapy is more safety and convinient, so that it will reduce frequent hospitalizations. As many researches, it is indicated that oral VGC 450mg daily can also reduce the adverse events resulting from posttransplant CMV infection, there is no significantly statistic differences when compared with oral VGC 900mg daily. Simultaneously, lower dose could decrease the risk of leukopenia and ease the burden for recipients.
This study is a single-center, prospective, observational, corhort study. According to the inclusion and exclusion criteria, the investigators will recruit 450 patients. And every one will be followed up for at least 12 months unless death or graft loss, the specific duration is at baseline, weekly within the first 3 months posttransplantation, month 4, month 5, month 6, month 9, and month 12. Recipients will be followed for CMV-DNA, CMV-pp65, CMV antigenemia, blood routine test, urinalysis, liver function, renal fuction and the chest X-ray films. Inverstigators should collect the date of recipient as below: general conditions, such as age, sex, weight and so on; primary reason for transplant; donor/recipient CMV serostatus; biopsy-prove acute rejection; opportunistic infections; NODAT; etc. And Chi-square or Fisher's exact test will be used as appropriate to compare categorical variables, and it is considered as statistically significant when the 2-sided P-value<0.05. Definitively, conclusion will be come out to verify the safety and availability of our protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Valganciclovir 900mg a day | – | Drug: ValganciclovirValganciclovir 900mg tablet by mouth begin within 10 days after renal transplant，once a day till to Day 100 posttransplant. |
| Valganciclovir 450mg a day | – | Drug: ValganciclovirValgancigclovir 450 mg tablet by mouth begin within 10 days after renal transplant，once a day till to Day 100 posttransplant. |
| Ganciclovir | – | Drug: GanciclovirGanciclovir 5mg/kg fluids by intravenous after renal transplant，once a day for the first 14 days；and than sequential Ganciclovir 1g tablet by mouth，third a day till to Day 100 posttransplant. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal Transplant Recipients
Key inclusion criteria (3 listed)
- 1.65 years old>=Age>=18 years old, male or female
- 2.Renal transplantation first time
- 3.CMV serology donor-positive(D+) or recipient-positive(R+) renal transplant recipients
Key exclusion criteria (9 listed)
- 1.Those who are allergic or resistant to Acyclovir, Valaciclovir, Ganciclovir, Valganciclovir
- 2.HIV, hepatitis B or hepatitis C patients
- 3.Not in pregnancy or lactation, pregnancy test was negative, and promise not to be pregnancy during treatment
- 4.Male with a pregnant partner; or lactation
- 5.Suspected CMV disease at enrolment
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 |
|---|---|---|
| ValganciclovirAlso: Valcyte, Valin ganciclovir, VGCOral at a dose of 450mg or 900mg per day begin within 10 days till to Day 100 posttransplant | Drug | Valganciclovir 450mg a day, Valganciclovir 900mg a day |
| GanciclovirAlso: Cymevene, GCVintravenous GCV 5mg/kg/d after renal transplantation for the first 14 days, and then oral GCV 1g 3 times daily till to Day 100 posttransplant. | Drug | Ganciclovir |
Primary outcome
incidence of CMV infection and disease
Time frame: within the first 1 year after renal transplant
6 secondary outcomes
incidence of CMV infection and disease
Time frame: within the first 3 and 6 months after renal transplant respectively
GCV-resistant CMV infection
Time frame: within the first 1 year after renal transplant
mean estimated renal function, allograft survival and patient survival
Time frame: within the first 1 year after renal transplant
incidence of acute rejection
Time frame: within the first 1 year after renal transplant
other opportunistic infections
Time frame: within the first 1 year after renal transplant
adverse events, such as NODAT
Time frame: within the first 1 year after renal transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Background: PubMed 10669413Tomasec P, Braud VM, Rickards C, Powell MB, McSharry BP, Gadola S, Cerundolo V, Borysiewicz LK, McMichael AJ, Wilkinson GW. Surface expression of HLA-E, an inhibitor of natural killer cells, enhanced by human cytomegalovirus gpUL40. Science. 2000 Feb 11;287(5455):1031. doi: 10.1126/science.287.5455.1031.
- Background: PubMed 10756006Retiere C, Prod'homme V, Imbert-Marcille BM, Bonneville M, Vie H, Hallet MM. Generation of cytomegalovirus-specific human T-lymphocyte clones by using autologous B-lymphoblastoid cells with stable expression of pp65 or IE1 proteins: a tool to study the fine specificity of the antiviral response. J Virol. 2000 May;74(9):3948-52. doi: 10.1128/jvi.74.9.3948-3952.2000.
- Background: PubMed 22486303Zheng Q, Tao R, Gao H, Xu J, Shang S, Zhao N. HCMV-encoded UL128 enhances TNF-alpha and IL-6 expression and promotes PBMC proliferation through the MAPK/ERK pathway in vitro. Viral Immunol. 2012 Apr;25(2):98-105. doi: 10.1089/vim.2011.0064.
- Background: PubMed 8394951Rubin RH. Infectious disease complications of renal transplantation. Kidney Int. 1993 Jul;44(1):221-36. doi: 10.1038/ki.1993.234. No abstract available.
- Background: PubMed 9041533Schmaldienst S, Horl WH. Bacterial infections after renal transplantation. Nephron. 1997;75(2):140-53. doi: 10.1159/000189523. No abstract available.
- Background: PubMed 17716883Streblow DN, Orloff SL, Nelson JA. Acceleration of allograft failure by cytomegalovirus. Curr Opin Immunol. 2007 Oct;19(5):577-82. doi: 10.1016/j.coi.2007.07.012. Epub 2007 Aug 22.
- Background: PubMed 16595079Szczepura A, Westmoreland D, Vinogradova Y, Fox J, Clark M. Evaluation of molecular techniques in prediction and diagnosis of cytomegalovirus disease in immunocompromised patients. Health Technol Assess. 2006 Apr;10(10):1-176. doi: 10.3310/hta10100.
- Background: PubMed 10787009Bendiksen S, Van Ghelue M, Rekvig OP, Gutteberg T, Haga HJ, Moens U. A longitudinal study of human cytomegalovirus serology and viruria fails to detect active viral infection in 20 systemic lupus erythematosus patients. Lupus. 2000;9(2):120-6. doi: 10.1191/096120300678828118.
- Background: PubMed 17112867Zhou L, Fan J, Zheng SS, Ma WH. Prevalence of human cytomegalovirus UL97 D605E mutation in transplant recipients in China. Transplant Proc. 2006 Nov;38(9):2926-8. doi: 10.1016/j.transproceed.2006.08.161.
- Background: PubMed 24940395Dong B, Wang Y, Wang G, Wang W, Zhou H, Fu Y. A retrospective study of cytomegalovirus pneumonia in renal transplant patients. Exp Ther Med. 2014 May;7(5):1111-1115. doi: 10.3892/etm.2014.1577. Epub 2014 Feb 24.
- Background: PubMed 24807640Meije Y, Fortun J, Len O, Aguado JM, Moreno A, Cisneros JM, Gurgui M, Carratala J, Munoz P, Montejo M, Blanes M, Bou G, Perez JL, Torre-Cisneros J, Ramos A, Pahissa A, Gavalda J; Spanish Network for Research on Infection in Transplantation (RESITRA) and the Spanish Network for Research on Infectious Diseases (REIPI). Prevention strategies for cytomegalovirus disease and long-term outcomes in the high-risk transplant patient (D+/R-): experience from the RESITRA-REIPI cohort. Transpl Infect Dis. 2014 Jun;16(3):387-96. doi: 10.1111/tid.12226. Epub 2014 May 8.
- Background: PubMed 25864986Fernandez-Ruiz M, Arias M, Campistol JM, Navarro D, Gomez-Huertas E, Gomez-Marquez G, Diaz JM, Hernandez D, Bernal-Blanco G, Cofan F, Jimeno L, Franco-Esteve A, Gonzalez E, Moreso FJ, Gomez-Alamillo C, Mendiluce A, Luna-Huerta E, Aguado JM; OPERA Study Group. Cytomegalovirus prevention strategies in seropositive kidney transplant recipients: an insight into current clinical practice. Transpl Int. 2015 Sep;28(9):1042-54. doi: 10.1111/tri.12586. Epub 2015 Apr 23.
- Individual participant dataSharing planned: No
Related trials for Renal Transplant Recipients
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Not yet recruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
Kidney Transplant, Kidney Transplant Failure and Rejection
Not yet recruitingPhase 2/3
Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus
Kidney Transplant Recipient
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.
Xiaoming D Ding, PhD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant Recipients, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Dec 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 China. 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.
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 Fan L Liu (8613201580779, liuf10@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of CMV infection and disease (time frame: within the first 1 year after renal transplant). 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 NCT02973464, which also lists 17 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 Dec 2016.