Observational study to assess the SARS-CoV-2 specific immune Response in patients with chronic kidney disease

Recruiting

• Conditions: Z99.2; U07.1; Dependence on renal dialysis; COVID-19, virus identified

• Registration Number: DRKS00024632
• Lead Sponsor: ierenzentrum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-23
• Results First Posted: 2021-05-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Arm 1: Patients on dialysis; hemo- or peritonealdialysis for longer than 1 month; no current immunosupppressive medication; no active malignancy; >18years of age.
Arm 2: patients without chronic kidney disease (>CKD Stadium 3b, eGFR >45ml/min/1.73m2); no immunosuppresssive medication; no active malignancy; >18years of age.

Exclusion Criteria

No informed consent available; not meeting above mentioned eligibility criteria.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 specific immunity after SARS-CoV-2 antigen exposure<br>1) Antibody-mediated immune response 28-42 days (=d) after SARS-CoV-2 antigen exposure (infection OR vaccination). Quantificatino of SARS-CoV-2 specific antibodies (IgG against nucleocapsid-antigen; IgG and IgM against receptor-binding-domain of S1-antigen)<br>2) Cellular immunity 28-42d after SARS-CoV-2 antigen exposure (infection OR exposure). Evaluation of SARS-CoV-2 antigen-specific t-cellular response by FACS-anaylsis

Secondary Outcome Measures

Name	Time	Method
SARS-CoV-2 specific immunity after SARS-CoV-2 antigen exposure, maximum of 10 measurements per patient, depending on availability<br>1) Antibody-mediated immune response, same as in primary outcome measures, at further time points (14-21d, 42-56d, 56-70d, 84-94d, 112-126d, 140-154d, 168-182d, 196-210d) after SARS-CoV-2 antigen exposure <br>2) Evaluation of cellular immunity as in primary outcome measures, at further time points (14-21d, 42-56d, 56-70d, 84-94d, 112-126d, 140-154d, 168-182d, 196-210d) after SARS-CoV-2 antigen exposure <br>