Long term efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation. A prospective observational cohort study by the REnal patients COVID-19 VACcination (RECOVAC) consortium

Long term efficacy and safety of SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation. A prospective observational cohort study by the REnal patients COVID-19 VACcination (RECOVAC) consortium - The LESS CoV-2 study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50845

Enrollment

12000

Registered

2021-03-25

Start date

2021-04-23

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

niertransplantatie, nieraandoeningen zowel in- als exclusief nefropathieën dialysis kidney insufficiency kidney transplantatie

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Eligible for COVID-19 vaccination as described by the instructions of the manufacturer 2. Age of 18 years or older 3. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained) 4. Either • eGFR

Exclusion criteria

Exclusion criteria: 1. 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). 2.Patients who participate in the RECOVAC-IR study.

Design outcomes

Primary

Measure	Time frame
The efficacy of SARS-CoV-2 vaccination determined as the incidence of COVID-19 after vaccination.	—

Secondary

Measure	Time frame
Safety in all patients: • Incidence of mortality • Incidence of adverse events of specific interest as defined by (inter)national authorities in collaboration with LAREB • Incidence of a combined endpoint of acute rejection or graft failure in patients after kidney transplantation • Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies (cPRA) > 5% in patients on the waiting list for their first kidney transplantation Efficacy in a subgroup of patients: • The antibody response against the SARS-CoV-2 Receptor Binding Domain at 28 days after the final SARS-CoV-2 vaccination. • The durability of antibody based immune response against SARS-CoV-2 Receptor Binding Domain at 6 months compared to 28 days after completion of SARS-CoV-2 vaccination.	—

Measure

Time frame

Safety in all patients: • Incidence of mortality • Incidence of adverse events of specific interest as defined by (inter)national authorities in collaboration with LAREB • Incidence of a combined endpoint of acute rejection or graft failure in patients after kidney transplantation • Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies (cPRA) > 5% in patients on the waiting list for their first kidney transplantation Efficacy in a subgroup of patients: • The antibody response against the SARS-CoV-2 Receptor Binding Domain at 28 days after the final SARS-CoV-2 vaccination. • The durability of antibody based immune response against SARS-CoV-2 Receptor Binding Domain at 6 months compared to 28 days after completion of SARS-CoV-2 vaccination.

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Countries

Netherlands

Outcome results