E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COVID-19 is associated with increased morbidity and mortality in kidney transplant recipients (KTR) and patients with chronic kidneydisease (CKD). Therefore, potential efficacious SARS-CoV-2 vaccination would be of great clinical importance in these patients.However, SARS-CoV-2 vaccination studies have excluded KTR and patients with CKD so-far and it is unknown how long a possible antibody response will endure. This will be the subject of this trial. |
COVID-19 geeft een verhoogde morbiditeit en mortaliteit bij niertransplantatie patienten en patiënten met chronische nierziekte (CKD). Daarom zou een effectieve SARS-CoV-2- vaccinatie bij deze patiënten van groot klinisch belang zijn. SARS-CoV-2-vaccinatiestudies hebben tot dusver niertransplantatie ontvangers en patiënten met CKD echter uitgesloten, daarnaast is het onbekend of een eventuele antistof response voor langere tijd aan zal houden. Dit zal het onderwerp van deze studie worden. |
|
E.1.1.1 | Medical condition in easily understood language |
The course of corona disease 2019 (COVID-19) is worse in kidney disease patients. A safe and effective vaccin against COVID-19 is crucial in these patients. |
Corona ziekte 2019 (COVID-19) heeft een ernstiger beloop in patiënten met een nierziekte. Een veilig en goed werkend vaccin is van cruciaal belang in deze patiënten. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084401 |
E.1.2 | Term | COVID-19 respiratory infection |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084464 |
E.1.2 | Term | COVID-19 immunization |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084465 |
E.1.2 | Term | COVID-19 vaccination |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084508 |
E.1.2 | Term | COVID-19 antibody test |
E.1.2 | System Organ Class | 100000004848 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084270 |
E.1.2 | Term | SARS-CoV-2 acute respiratory disease |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084272 |
E.1.2 | Term | SARS-CoV-2 infection |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084462 |
E.1.2 | Term | SARS-CoV-2 vaccination |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084463 |
E.1.2 | Term | SARS-CoV-2 immunisation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023439 |
E.1.2 | Term | Kidney transplant rejection |
E.1.2 | System Organ Class | 10021428 - Immune system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023438 |
E.1.2 | Term | Kidney transplant |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061105 |
E.1.2 | Term | Dialysis |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10018875 |
E.1.2 | Term | Haemodialysis |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10034660 |
E.1.2 | Term | Peritoneal dialysis |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10064848 |
E.1.2 | Term | Chronic kidney disease |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10076412 |
E.1.2 | Term | Chronic kidney disease stage 5 |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10076411 |
E.1.2 | Term | Chronic kidney disease stage 4 |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy of SARS-CoV vaccination by the incidence of COVID-19 in patients with chronic kidney disease stage G4-G5, on dialysis and patients after kidney transplantation who received SARS-CoV-2 vaccination |
Het bepalen van de effectiviteit van SARS-CoV-2 vaccinatie middels de incidentie van COVID-19 in patiënten met chronische nierziekte stadium G4-G5, dialyse of na transplantatie na SARS-CoV-2 vaccinatie |
|
E.2.2 | Secondary objectives of the trial |
- To assess the antibody response at 28 days after SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis and in patients after kidney transplantation - To assess durability of the antibody response at 6 months after SARS-CoV 2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis and in patients after kidney transplantation - To assess the safety of vaccination
|
- Om de antilichaam response te bepalen 28 dagen na SARS-CoV-2 vaccinatie in patiënten met chronische nierziekte stadium G4-G5, dialyse of na niertransplantatie - Om de duur van de antistofrespons te bepalen in patiënten met chronische nierziekte stadium G4-G5, dialyse of na niertransplantatie door het meten van antistoffen 6 maanden na vaccinatie. - Het bepalen van de veiligheid van vaccinatie |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 30 ml/min/1.73m2 but not on dialysis or with a kidney transplant - Hemodialysis, or peritoneal dialysis - Kidney Transplant recipient at least 6 weeks after transplantation
|
1. Geschikt om COVID-19 vaccinatie te ontvangen volgens de instructies van de fabrikant 2. Leeftijd van 18 jaar of ouder 3. In staat om het doel en de risico's van de studie te begrijpen, volledig geïnformeerd te worden en in staat zijn om geschreven informed consent te geven. 4. Een van de volgende: - eGFR <30 ml/min/1.73m2 maar niet met dialyse of na niertransplantatie - Hemodialyse of peritoneaal dialyse - Niertransplantatieontvanger tenminste 6 weken na transplantatie |
|
E.4 | Principal exclusion criteria |
• 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). • Patients who opted out for research in the Santeon, RENINE and NOTR registries. • Patients who participate in the RECOVAC-IR study.
|
- Voorgeschiedenis met een ernstige reactie geassocieerd met een vaccin en/of een ernstige allergische reactie op enig component van de studie interventie(s) - Patienten die aangeven dat ze hun data, geregistreerd in bestaande registratie studies (Santeon, RENINE, NOTR), niet met dit onderzoek willen delen - Patiënten die meedoen aan de RECOVAC-IR studie |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The incidence of COVID-19 in a two years period after SARS- CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation. |
De incidentie van COVID-19 in een periode van twee jaar na SARS-CoV-2 vaccinatie in patiënten met chronische nierziekte stadium G4-G5, dialyse of na niertransplantatie. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Two years after SARS-CoV-2 vaccination |
Twee jaar na SARS-CoV-2 vaccinatie |
|
E.5.2 | Secondary end point(s) |
• Efficacy: o The antibody based immune response to vaccination against COVID-19 at day 28 after the second vaccination. o The durability of the antibody response at 6 months after SARS-CoV 2 vaccination
• Safety: • Incidence of mortality • Incidence of adverse events of specific interest as defined by (inter)national authorities • 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 dialysis patients on the waiting list for their first kidney transplantation
|
Effectiviteit: - De antistof immuun respons 28 dagen na de tweede vaccinatie - De duur van de antistofrerspons op 6 maanden na SARS-CoV-2 vaccinatie
Veiliigheid: - Incidentie van mortaliteit - Incidentie van bijwerkingen van specifieke interesse gedefinieerd door (inter)nationale autoriteiten. - Incidentie van een gecombineerd eindpunt van acute rejectie of transplantaatfalen in patiënten na niertransplantatie - Incidentie van HLA anstistoffen gedefineerd als een calculated Panel Reactivity Antibodies (cPRA) > 5% bij dialyse patiënten die op de wachtlijst staan voor een eerste niertransplantatie |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Antibody response: 28 days and 6 months after vaccination Other endpoints over a period of 2 years |
Antilichaam response: 28 dagen en 6 maanden na vaccinatie Andere eindpunten over een periode van 2 jaar |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
If the last subject is two years after SARS-CoV-2 vaccination |
Wanneer de laaste deelnemer twee jaar na SARS-CoV-2 vaccinatie is |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |