Prospective Randomized trial of Everolimus replacing MMF/MP Acid by the RECOVAC consortium to increase VACcine response in kidney transplant patients

Conditions

kidney transplantation, COVID-19, Herpes Zoster, impaired immunity

Brief summary

The neutralizing antibody titer against the Omicron XBB.1.5 strain 28 days after monovalent Omicron XBB.1.5. COVID-19 vaccination in patients continuing MMF/MPA compared to patients who switched to everolimus.

Detailed description

SARS-CoV-2 specific anti-S1 antibody level at 28 days after COVID-19 vaccination, Varicella zoster specific anti-gE antibody level 28 days after 1st and 2nd herpes zoster vaccination, SARS-CoV-2 specific T-cell response at 28 days after COVID-19 vaccination, Varicella zoster specific T-cell response at 28 days after 2nd herpes zoster vaccination, Incidence of treated acute rejection, Change in estimated glomerular filtration rate and proteinuria during the study, Incidence of serious adverse events throughout the study, Incidence of adverse events of special interest throughout the study, Incidence of dnDSAs at V7, or when not participating in second part of the study at V5., Incidence of solicited adverse events of COVID-19 vaccination during 7 days after vaccination, Incidence of solicited adverse events of herpes zoster vaccination during 7 days after each vaccination

Related papers

No related papers found yet.

Interventions

DRUGCellCept 1 g/5 ml powder for oral suspension

DRUGCertican 0

DRUG25

DRUGtabletten 0

DRUG25 mg

DRUGCellCept 250 mg capsules

DRUGMyfortic 360 mg

DRUGmaagsapresistente tablet

DRUGShingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant

DRUGadjuvanted)

DRUGCellCept 500 mg film-coated tablets

DRUG5

DRUG5 mg

DRUGCertican 1

DRUG0

DRUGtabletten 1

DRUG0 mg

DRUG75

DRUG75 mg

DRUGMyfortic 180 mg

DRUGComirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The neutralizing antibody titer against the Omicron XBB.1.5 strain 28 days after monovalent Omicron XBB.1.5. COVID-19 vaccination in patients continuing MMF/MPA compared to patients who switched to everolimus.	—

Secondary

Measure	Time frame
SARS-CoV-2 specific anti-S1 antibody level at 28 days after COVID-19 vaccination, Varicella zoster specific anti-gE antibody level 28 days after 1st and 2nd herpes zoster vaccination, SARS-CoV-2 specific T-cell response at 28 days after COVID-19 vaccination, Varicella zoster specific T-cell response at 28 days after 2nd herpes zoster vaccination, Incidence of treated acute rejection, Change in estimated glomerular filtration rate and proteinuria during the study, Incidence of serious adverse events throughout the study, Incidence of adverse events of special interest throughout the study, Incidence of dnDSAs at V7, or when not participating in second part of the study at V5., Incidence of solicited adverse events of COVID-19 vaccination during 7 days after vaccination, Incidence of solicited adverse events of herpes zoster vaccination during 7 days after each vaccination	—

Measure

Time frame

SARS-CoV-2 specific anti-S1 antibody level at 28 days after COVID-19 vaccination, Varicella zoster specific anti-gE antibody level 28 days after 1st and 2nd herpes zoster vaccination, SARS-CoV-2 specific T-cell response at 28 days after COVID-19 vaccination, Varicella zoster specific T-cell response at 28 days after 2nd herpes zoster vaccination, Incidence of treated acute rejection, Change in estimated glomerular filtration rate and proteinuria during the study, Incidence of serious adverse events throughout the study, Incidence of adverse events of special interest throughout the study, Incidence of dnDSAs at V7, or when not participating in second part of the study at V5., Incidence of solicited adverse events of COVID-19 vaccination during 7 days after vaccination, Incidence of solicited adverse events of herpes zoster vaccination during 7 days after each vaccination

—

Countries

Netherlands

Outcome results

None listed