Observational study to assess the SARS-CoV-2 specific immune response in kidney transplant recipients (COVID-19 related immune response)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024668

Enrollment

150

Registered

2021-03-23

Start date

2021-03-23

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Z94.0 U07.1

Interventions

Group 1: Investigation of SARS-CoV-2 specific immunity in Kidney transplant recipients or combined kidney-pancreas transplant recipients (de novo or re-transplanted) Group 2: Investigation of SARS-CoV

Eligibility

Sex/Gender

All

Age

5 Years to No maximum

Inclusion criteria

Inclusion criteria: Arm 1: Kidney transplant recipients (de-novo or re-transplanted); kidney-pancreas transplant recipients (de-novo or re-transplanted); no active malignancy; =5 years of age. Arm 2: patients without chronic kidney disease (>CKD Stadium 3b (GFR >45 ml/min/1.73m2)); no current immunosuppressive medication; no active malignancy; =5 years of age. Arm 3: patients with renal disease without kidney transplantation; no active malignancy; =5 years of age.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
SARS-CoV-2 specific immunity after SARS-CoV-2 antigen exposure 1) antibody-mediated immune response 28-42 days (=d) after SARS-CoV-2 antigen exposure (infection OR vaccinatino). Quantification of SARS-CoV-2 specific antibodies (IgG against nucleocapsid-antigen; IgG and IgM against receptor-binding-domain of S1-antigen) 2) cellular immunity 28-42d after SARS-CoV-2 antigen exposure (infectino OR exposure). Evaluation of SARS-CoV-2 antigen-specific t-cellular response by FACS-analysis	—

Measure

Time frame

SARS-CoV-2 specific immunity after SARS-CoV-2 antigen exposure 1) antibody-mediated immune response 28-42 days (=d) after SARS-CoV-2 antigen exposure (infection OR vaccinatino). Quantification of SARS-CoV-2 specific antibodies (IgG against nucleocapsid-antigen; IgG and IgM against receptor-binding-domain of S1-antigen) 2) cellular immunity 28-42d after SARS-CoV-2 antigen exposure (infectino OR exposure). Evaluation of SARS-CoV-2 antigen-specific t-cellular response by FACS-analysis

—

Secondary

Measure	Time frame
SARS-CoV-2 specific immunity after SARS-CoV-2 antigen exposure, maximum of 10 measurements per patient, depending on availability 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 2) Evaluation of cellular immunity, 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	—

Measure

Time frame

SARS-CoV-2 specific immunity after SARS-CoV-2 antigen exposure, maximum of 10 measurements per patient, depending on availability 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 2) Evaluation of cellular immunity, 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

—

Countries

Germany

Contacts

Public ContactLouise Benning

Nierenzentrum Heidelberg, Universitätsklinikum Heidelberg

louise.benning@med.uni-heidelberg.de06221-91120

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 13, 2026