A Randomized Trial of Valganciclovir Prophylaxis Versus Preemptive Therapy in Kidney Transplant Recipients
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00669806%3A_____%2F23%3A10462239" target="_blank" >RIV/00669806:_____/23:10462239 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11140/23:10462239
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=1XZrImO6oU" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=1XZrImO6oU</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1681/ASN.0000000000000090" target="_blank" >10.1681/ASN.0000000000000090</a>
Alternative languages
Result language
angličtina
Original language name
A Randomized Trial of Valganciclovir Prophylaxis Versus Preemptive Therapy in Kidney Transplant Recipients
Original language description
Background The optimal regimen for the prevention of cytomegalovirus (CMV) infection in kidney transplant recipients, primarily in terms of reducing indirect CMV effects, has not been defined.Methods This was an open-label, single-center, randomized clinical trial of valganciclovir prophylaxis vs preemptive therapy in 140 kidney transplant recipients recruited between June 2013 and May 2018. CMV-seronegative recipients with negative donors (D-R-) were excluded. Patients were randomized 1:1 to receive either valganciclovir prophylaxis, 900 mg, daily for 3 months (6 months in D+R-) (n=70) or preemptive therapy (valganciclovir, 900 mg, twice daily until 2 consecutive negative tests) for CMV DNAemia (>=1000 IU/mL) detected by weekly CMV PCR for 4 months (n=70). The primary outcome was the incidence of acute rejection at 12 months, as confirmed by biopsy. Key secondary outcomes included subclinical rejection, CMV disease and DNAemia, and neutropenia.Results The incidence of acute rejection was numerically lower with valganciclovir prophylaxis than with preemptive therapy (13%, 9/70 vs 23%, 16/70, P=0.112 [HR, 0.52, 95% CI, 0.23-1.19]). Subclinical rejection at 3 months was lower in the prophylaxis group (13% vs 29%, P=0.027). Both regimens prevented CMV disease (4% vs 4%, P=0.974). Preemptive therapy resulted in higher rates of CMV DNAemia (44% vs 75%, P<0.001) including episodes with higher viral load (>=2000 IU/mL, P<0.001) but lower valganciclovir exposure (P<0.001) and neutropenia (P=0.019).Conclusion Among kidney transplant recipients, the use of valganciclovir prophylaxis, compared with preemptive therapy, did not result in a significantly lower incidence of acute rejection.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30217 - Urology and nephrology
Result continuities
Project
<a href="/en/project/EF16_019%2F0000787" target="_blank" >EF16_019/0000787: Fighting INfectious Diseases</a><br>
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Journal of the American Society of Nephrology
ISSN
1046-6673
e-ISSN
1533-3450
Volume of the periodical
34
Issue of the periodical within the volume
5
Country of publishing house
US - UNITED STATES
Number of pages
15
Pages from-to
920-934
UT code for WoS article
000985661800021
EID of the result in the Scopus database
2-s2.0-85159254911