E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic peritoneal dialysis patients |
Chronische Peritonealdialyse PatientInnen |
|
E.1.1.1 | Medical condition in easily understood language |
Patients who suffer CKD and undergo a special form of dialysis, i.e. peritoneal dialysis |
Patienten die an einer chronischen Nierenerkrankung leiden und eine spezielle Form der Dialyse, nämlich der Peritonealdialyse untergehen |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
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 |
The present study aims to determine the serological immune response to the new SARS-CoV-2 vaccine (COVID-19 vaccine Moderna) in patients on chronic PD, as assessed by Roche Elecsys Anti-SARS-CoV2 S (Roche, )which detects antibodies against the SARS-CoV-2 virus (including neutralizing antibodies). Based on this study, conclusions can be drawn on whether the immune response is sufficient or alternative dosing regimens of vaccines might need further exploration. |
Diese Studie versucht die serologische Immunantwort auf die neue SARS-CoV-2 Impfung von Moderna in chronischen PD Patienten durch Assessment der Antikörper via des Roche Elecsys Anti-SARS-CoV-2 S festzustellen. Basierend auf dieser Studie können Rückschlüsse auf die suffiziente Immunantwort in diesen Patienten geben oder ob alternative Dosierregime untersucht werden müssen. |
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E.2.2 | Secondary objectives of the trial |
Exploratory analysis: associations between baseline (immune) parameters, age strata (18- 59 and >=60 years of age), frailty score, HBV responder-status (non-responder: HBV titer <10 IE/L, low-responder: HBV titer 10-99 IE/L, responder: anti-HBs titer >100IE/L) with the serological response to the SARS-CoV-2 vaccination. |
Explorative Analyse: Assoziationen zwischen den Baseline Immunparamtern, Altersstratifizierung, Gebrechlichkeitsscore, HBV Immunantwortstatus |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18 to 90 years of age End stage kidney disease patient undergoing peritoneal dialysis Patient was scheduled to receive an approved SARS-CoV2 vaccine as part of their routinely performed care Provided written informed consent for the “Bio-Bank” |
Alter zwischen 18 und 90 Jahren Dialysepflichtige Nierenerkrankung (PD) Patient hatte geplante Impfung mit Moderna Impfstoff Unterschriebener IC für die Biobank |
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E.4 | Principal exclusion criteria |
No informed consent of the “Bio-Bank” was obtained
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Falls der IC nicht unterschrieben wurde |
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E.5 End points |
E.5.1 | Primary end point(s) |
The anti-SARS-CoV2 level (estimated as geometric mean concentration, GMC) in patients on chronic dialysis (peritoneal dialysis) after the vaccination with COVID- 19 vaccine Moderna |
Anstieg der GMC (Geometrie mean concentration) in chronischen Dialysepatientinnen (PD) nach der Impfung mit dem COVID-19 Impfstoff von Moderna |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
4 weeks after first vaccination dose and 4 weeks after second vaccination dose |
4 Wochen nach erfolgter 1. und 4 Wochen nach erfolgter 2. Teilimpfung |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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 | Yes |
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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Retrospektive, nicht-invasive Studie |
Retrospective, non invasive study |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |