Determination of Covid-19 antibodies after vaccination with a mRNA vaccine in peritoneal dialysis patients

Retrospective quantification of anti-SARS-CoV-2 antibody response after mRNA COVID-19 vaccine in patients treated with peritoneal dialysis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002984-23-AT

Enrollment

Registered

2021-07-19

Start date

2021-08-01

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Chronic peritoneal dialysis patients

Interventions

Trade Name: Covid-19 Vaccine Moderna Product Name: COVID-19 Vaccine Moderna Pharmaceutical Form: Injection INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified) CAS Number: PR1 Current

Eligibility

Sex/Gender

All

Inclusion criteria

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” Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: No informed consent of the “Bio-Bank” was obtained

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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 100IE/L) with the serological response to the SARS-CoV-2 vaccination.;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 ;Timepoint(s) of evaluation of this end point: 4 weeks after first vaccination dose and 4 weeks after second vaccination dose	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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 100IE/L) with the serological response to the SARS-CoV-2 vaccination.;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 ;Timepoint(s) of evaluation of this end point: 4 weeks after first vaccination dose and 4 weeks after second vaccination dose

—

Secondary

Measure	Time frame
Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -	—

Countries

Austria

Contacts

Public ContactClinical Trials Information

Medical University of Graz

alexander.kirsch@medunigraz.at

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026