Trial document




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  DRKS00024668

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Kidney transplant recipients are due to their medical need of immunosuppressive medication following transplantation as well as their often coexisting comorbidities, especially regarding the cardiovascular system, at high risk for a severe course of COVID-19 disease when compared to healthy individuals. On the other hand the fast development of SARS-CoV_2 specific vaccines give hope to fighting the current COVID-19 pandemic.

It is already known, that the antibody-mediated as well as cell-mediated immune response of immunocompromised patients to other viral diseases or vaccinations against viral diseases, such as Influenza or Hepatitis B, is impaired. Current research suggests that immunocompromised patients develop an adequate immune response to an infection with SARS-CoV-2. It is however not known, how the immune response to SARS-CoV-2 specific vaccination is.

In this study the immune response following COVID-19 diesease or SARS-CoV-2 infection in renal transplant recipients will be assessed. Healthy participants without chronic kidney disease will serve as control.

Amendment 1: Patients with renal disease without kidney transplantation will be included as an additional study arm.

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Brief Summary in Scientific Language

At present, two mRNA vaccines are approved for vaccination against COVID-19: BNT162b2/Comirnaty (BioNTech/Pfizer) and mRNA-1273/COVID-19-vaccine (Moderna). At the end of january another, vector-based vaccine, AZD1222 (AstraZeneca) further got approval. All three vaccines demonstrated sufficient efficacy in preventing COVID-19 disease and led to significant reduction in severe courses of COVID-19 disease in vaccinated participants. As the authorisation studies however only included healthy individuals, little is known about vaccine induced immunity in immunocompromised patients.
Studies regarding influenza vaccination in renal transplant recipients showed significant impaired vaccine-induced immunity due to immunosuppressive medication. In a prospective vaccination study regarding vaccination against Hepatitis A in immunisuppressed liver- and kidney transplant recipients a fast humoral response to vaccination could be demonstrated, however, antibody titers decreased faster than in healthy control participants.

Recent studies could show an adequate antibody-mediated and cellular response following SARS-CoV-2 infection, even in immunocompromised patients. However, little is known on how long this immunity after COVID-19 infection lasts.

In this observational trial the humoral and cellular response to SARS-CoV-2 antigen exposure, either by infection of by vaccination will be evaluated in renal transplant recipients. Participants without chronic kidney disease will serve as healthy controls.

Amendment 1: Patients with renal disease without kidney transplantation will be included as an additional study arm.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

Data will not be shared due to monocentric observational character of this study.

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Organizational Data

  •   DRKS00024668
  •   2021/03/23
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  •   yes
  •   Approved
  •   S-201/2021, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   01KX2021  (BMBF Förderkennzeichen)
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Health Condition or Problem studied

  •   Z94.0 -  Kidney transplant status
  •   U07.1 -  Emergency use of U07.1
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Interventions/Observational Groups

  •   Investigation of SARS-CoV-2 specific immunity in Kidney transplant recipients or combined kidney-pancreas transplant recipients (de novo or re-transplanted)
  •   Investigation of SARS-CoV-2 specific immunity in Patients without chronic kidney disease (>CKD Stadium 3b (GFR >45 ml/min/1.73m2))
  •   Investigation of SARS-CoV-2 specific immunity in patients with renal disease without kidney transplantation
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/03/23
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   no maximum age
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Additional 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.

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Exclusion Criteria

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

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Addresses

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    • Nierenzentrum Heidelberg
    • Im Neuenheimer Feld 162
    • 69120  Heidelberg
    • Germany
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    •   49 (0)6221/91120
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    • Zentrum für Kinder- und Jugendmedizin
    • Mr.  Prof. Dr. med.  Burkhard  Tönshoff 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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    • Zentrum für Kinder- und Jugendmedizin
    • Mr.  Dr. med.  Maximilian  Stich 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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    • Nierenzentrum Heidelberg, Universitätsklinikum Heidelberg
    • Ms.  Dr. med.  Louise  Benning 
    • Im Neuenheimer Feld 162
    • 69120  Heidelberg
    • Germany
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    • Nierenzentrum Heidelberg
    • Mr.  Dr. med.  Claudius  Speer 
    • Im Neuenheimer Feld 162
    • 69120  Heidelberg
    • Germany
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    • Nierenzentrum Heidelberg, Universitätsklinikum Heidelberg
    • Ms.  Dr. med.  Louise  Benning 
    • Im Neuenheimer Feld 162
    • 69120  Heidelberg
    • Germany
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    • Nierenzentrum Heidelberg
    • Mr.  Dr. med.  Claudius  Speer 
    • Im Neuenheimer Feld 162
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Nierenzentrum Heidelberg
    • Im Neuenheimer Feld 162
    • 69120  Heidelberg
    • Germany
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    •   49 (0)6221/91120
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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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    • Dietmar Hopp Stiftung
    • Opelstraße 28
    • 68789  St.Leon-Rot
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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