Created at Source Raw Value Validated value
June 25, 2024, noon usa

* previous cni trough levels not sufficient according to the discretion of the treating physician * more than two previous kidney transplantations * calculated level of panel reactive antibodies prior to last transplantation above 85% * evidence of dsas * signs of acute rejection during the preceding year * multi-organ transplant recipient * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s) * contra-indications for use of everolimus according to the opinion of the treating physician * active covid-19 disease * active malignancy, except non-melanoma skin cancer * inherited immune deficiency * infection with human immunodeficiency virus (hiv) * administration of t-cell, b-cell, or plasma cell depleting antibodies during the last 6 months * bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection * subjects with severe systemic infections, current or within the two weeks prior to randomisation * subjects with severe restrictive or obstructive pulmonary disorders * subjects with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled * subjects with white blood cell (wbc) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3 at last outpatient clinic visit * proteinuria \> 1 gram/day at last outpatient clinic visit * simultaneous participation in another interventional study that will likely influence the study outcomes * subject who are actively trying to get pregnant or are pregnant additional exclusion criteria for part 2: * active varicella or herpes zoster disease * herpes zoster vaccination with the live attenuated vaccine (zostavax) or varicella vaccination (provarivax) during the conduct of the study * previous herpes zoster vaccination with the rzv

* previous cni trough levels not sufficient according to the discretion of the treating physician * more than two previous kidney transplantations * calculated level of panel reactive antibodies prior to last transplantation above 85% * evidence of dsas * signs of acute rejection during the preceding year * multi-organ transplant recipient * history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s) * contra-indications for use of everolimus according to the opinion of the treating physician * active covid-19 disease * active malignancy, except non-melanoma skin cancer * inherited immune deficiency * infection with human immunodeficiency virus (hiv) * administration of t-cell, b-cell, or plasma cell depleting antibodies during the last 6 months * bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection * subjects with severe systemic infections, current or within the two weeks prior to randomisation * subjects with severe restrictive or obstructive pulmonary disorders * subjects with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled * subjects with white blood cell (wbc) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3 at last outpatient clinic visit * proteinuria \> 1 gram/day at last outpatient clinic visit * simultaneous participation in another interventional study that will likely influence the study outcomes * subject who are actively trying to get pregnant or are pregnant additional exclusion criteria for part 2: * active varicella or herpes zoster disease * herpes zoster vaccination with the live attenuated vaccine (zostavax) or varicella vaccination (provarivax) during the conduct of the study * previous herpes zoster vaccination with the rzv

Oct. 31, 2023, 4 p.m. usa

previous cni trough levels not sufficient according to the discretion of the treating physician more than two previous kidney transplantations calculated level of panel reactive antibodies prior to last transplantation above 85% evidence of dsas signs of acute rejection during the preceding year multi-organ transplant recipient history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s) contra-indications for use of everolimus according to the opinion of the treating physician active covid-19 disease active malignancy, except non-melanoma skin cancer inherited immune deficiency infection with human immunodeficiency virus (hiv) administration of t-cell, b-cell, or plasma cell depleting antibodies during the last 6 months bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection subjects with severe systemic infections, current or within the two weeks prior to randomisation subjects with severe restrictive or obstructive pulmonary disorders subjects with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled subjects with white blood cell (wbc) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3 at last outpatient clinic visit proteinuria > 1 gram/day at last outpatient clinic visit simultaneous participation in another interventional study that will likely influence the study outcomes subject who are actively trying to get pregnant or are pregnant additional exclusion criteria for part 2: active varicella or herpes zoster disease herpes zoster vaccination with the live attenuated vaccine (zostavax) or varicella vaccination (provarivax) during the conduct of the study previous herpes zoster vaccination with the rzv

previous cni trough levels not sufficient according to the discretion of the treating physician more than two previous kidney transplantations calculated level of panel reactive antibodies prior to last transplantation above 85% evidence of dsas signs of acute rejection during the preceding year multi-organ transplant recipient history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s) contra-indications for use of everolimus according to the opinion of the treating physician active covid-19 disease active malignancy, except non-melanoma skin cancer inherited immune deficiency infection with human immunodeficiency virus (hiv) administration of t-cell, b-cell, or plasma cell depleting antibodies during the last 6 months bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection subjects with severe systemic infections, current or within the two weeks prior to randomisation subjects with severe restrictive or obstructive pulmonary disorders subjects with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled subjects with white blood cell (wbc) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3 at last outpatient clinic visit proteinuria > 1 gram/day at last outpatient clinic visit simultaneous participation in another interventional study that will likely influence the study outcomes subject who are actively trying to get pregnant or are pregnant additional exclusion criteria for part 2: active varicella or herpes zoster disease herpes zoster vaccination with the live attenuated vaccine (zostavax) or varicella vaccination (provarivax) during the conduct of the study previous herpes zoster vaccination with the rzv

June 30, 2023, noon usa

previous cni trough levels not sufficient according to the discretion of the treating physician more than two previous kidney transplantations calculated level of panel reactive antibodies prior to last transplantation above 85% evidence of dsas signs of acute rejection during the preceding year multi-organ transplant recipient history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s) contra-indications for use of everolimus according to the opinion of the treating physician active covid-19 disease active varicella or herpes zoster disease active malignancy, except non-melanoma skin cancer inherited immune deficiency infection with human immunodeficiency virus (hiv) administration of t-cell, b-cell, or plasma cell depleting antibodies during the last 6 months bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection subjects with severe systemic infections, current or within the two weeks prior to randomisation subjects with severe restrictive or obstructive pulmonary disorders subjects with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled subjects with white blood cell (wbc) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3 at last outpatient clinic visit proteinuria > 1 gram/day at last outpatient clinic visit herpes zoster vaccination with the live attenuated vaccine (zostavax) or varicella vaccination (provarivax) during the conduct of the study previous herpes zoster vaccination with the rzv simultaneous participation in another interventional study that will likely influence the study outcomes subject who are actively trying to get pregnant or are pregnant

previous cni trough levels not sufficient according to the discretion of the treating physician more than two previous kidney transplantations calculated level of panel reactive antibodies prior to last transplantation above 85% evidence of dsas signs of acute rejection during the preceding year multi-organ transplant recipient history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s) contra-indications for use of everolimus according to the opinion of the treating physician active covid-19 disease active varicella or herpes zoster disease active malignancy, except non-melanoma skin cancer inherited immune deficiency infection with human immunodeficiency virus (hiv) administration of t-cell, b-cell, or plasma cell depleting antibodies during the last 6 months bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection subjects with severe systemic infections, current or within the two weeks prior to randomisation subjects with severe restrictive or obstructive pulmonary disorders subjects with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled subjects with white blood cell (wbc) count ≤ 2,000/mm3 or with platelet count ≤ 50,000/mm3 at last outpatient clinic visit proteinuria > 1 gram/day at last outpatient clinic visit herpes zoster vaccination with the live attenuated vaccine (zostavax) or varicella vaccination (provarivax) during the conduct of the study previous herpes zoster vaccination with the rzv simultaneous participation in another interventional study that will likely influence the study outcomes subject who are actively trying to get pregnant or are pregnant