COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05924685

Jan-Stephan F Sanders, MD PhD

j.sanders@umcg.nl

2023-06-29

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

inclusion criteria: age ≥ 18 years ≥6 months after kidney transplantation maintenance immunosuppressive therapy consisting of either triple or dual therapy including mmf/mpa with a minimum daily dose of 1000 mg (mmf) or 720 mg (mpa) and a cni eligible for the vaccinations as described by the instructions of the manufacturers of the vaccines (e.g. received 3 previous covid-19 vaccinations as part of the primary covid-19 immunisation) capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained) willing to adhere to the protocol and be available during the study period

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

2

University Medical Center Groningen

18

100

Netherlands

High risk patients

N/A

110

Virus-neutralizing capacity of SARS-CoV-2 Omicron BA4.5 antibodies

None

Phase 4

[{"arm_notes": "Immunosuppressive therapy with MMF/MPA ", "treatment_id": 2696, "treatment_name": "Mrna vaccine bivalent", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Replace immunosuppressive therapy with MMF/MPA by everolimus ", "treatment_id": 2696, "treatment_name": "Mrna vaccine bivalent", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]