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The role of pre-formed alloreactive T cells on acute rejection episodes and long-term graft outcome in patients after living donor renal transplantation



Short title: ALLO

Investigated disease: The role of pre-formed alloreactive T cells

Principal Investigator: Prof. Dr. Klemens Budde


Clinic, Institute: Medizinische Klinik m.S. Nephrologie und Internistische Intensivmedizin CCM

Patient (diseased)
Age: 18 - 99
Gender: All

Status: Participants wanted
Last change: 23.09.2021

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Study Description

Title

The role of pre-formed alloreactive T cells on acute rejection episodes and long-term graft outcome in patients after living donor renal transplantation

Short title

ALLO

General Short Description

The role of pre-formed alloreactive T cells on acute rejection episodes and long-term graft outcome in patients after living donor renal transplantation

Scientific Short Description

The role of pre-formed alloreactive T cells on acute rejection episodes and long-term graft outcome in patients after living donor renal transplantation

Investigated Disease, Health Issue

ICD-Code
  • Z94.0 - Zustand nach Nierentransplantation

Inclusion Criteria

Age

18 - 99

Gender

All

Additional Inclusion Criteria
  • Written informed consent
  • First or second renal transplantation
  • Living donor renal transplantation
  • Recipient older than 18 years
  • Negative cross match
  • Planed quadruple, Tacrolimus-based (low-dose) immunosuppressive drug regimen (Tacrolimus, 2g MMF starting dose, (methyl)prednisolone according to center practice, basiliximab at day 0 and day 4)
  • Planned start of Tacrolimus (Advagraf®) 3 to 10 days prior to transplantation (trough levels 5-10 ng/ml during the first 3 months, 5-7 ng/ml thereafter)

Exclusion Criteria

  • Planed T-cell depleting induction therapy
  • Pregnancy
  • Pre-existing, moderate to high dose immunosuppressive medication
  • Pre-existing, severe lymphopenia (< 400/µl)

Characteristics

Studytype

Non-interventional

Studyphase

N/A

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