Trial document




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  DRKS00005786

Trial Description

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Title

HARMONY-Follow-up-Study
(Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients)

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Trial Acronym

HARMONY-Follow-up

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In the HARMONY-trial (EuCTR2007-006516-31-DE) different medicamentous immunosuppressive therapy strategies were investigated up to one year after transplantation. Especial-ly, it was looked for the best strategy to terminate the cortisone therapy.
Aim of this investigation now is, to reanalyze the outcome of the HARMONY-trial 3 and 5 years after transplantation during the routinely post-transplantational care and to gain additional blood and urine samples.
This will help to evaluate the long term achievements of the therapy strategies used in the HARMONY-trial.
In addition to this, using new experimental methods to analyze the new blood and urine samples together with the old ones from the HARMONY-trial should lead to new marker for early detection of graft rejections and infections as well as marker for regulation of immune suppression after kidney transplantation.

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Brief Summary in Scientific Language

In the HARMONY-trial (EuCTR2007-006516-31-DE) the standard steroid therapy (Advagraf, CellCept, Decortin H + 2x Simulect day 0 + 4) were compared against steroidfree therapies (arm 2: Advagraf, CellCept, Decortin H until day 8, 2x Simulect day 0 +4; arm3: Advagraf, CellCept, Decortin H until day 8, 3x Thymoglubulin) up to one year after transplantation.
Especially, it was looked for the best strategy to terminate the cortisone therapy.
Aim of this investigation now is, to reanalyze the outcome of at least 500 patients the HARMONY-trial 3 and 5 years after transplantation during the routinely post-transplantational care and to gain additional blood and urine samples.
This will help to evaluate the long term achievements of the therapy strategies used in the HARMONY-trial.
In addition to this, using new experimental methods to analyze the new blood and urine samples together with the old ones from the HARMONY-trial should lead to new marker for early detection of graft rejections and infections as well as marker for regulation of immune suppression after kidney transplantation.

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Organizational Data

  •   DRKS00005786
  •   2014/03/10
  •   [---]*
  •   yes
  •   Approved
  •   EK 364092013, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

  •   U1111-1154-2186 
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Health Condition or Problem studied

  •   Z94.0 -  Kidney transplant status
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   In this study the intervention arms of the HARMONY study will be proved again, there will be no new intervention:
    Intervention arm A:
    Standard: Advagraf, CellCept, Decortin H + 2xSimulect day 0 +4
  •   In this study the intervention arms of the HARMONY study will be proved again, there will be no new intervention
    Intervention Arm B - Steroid free:
    Advagraf, Cellcept, Decortin H until day 8, 2x Simulect day 0 + 8
  •   In this study the intervention arms of the HARMONY study will be proved again, there will be no new intervention
    Intervention Arm C -Steroid free:
    Advagraf, Cellcept, Decortin H until day 8 3x Thymoglobin
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

rate and severity of acute bioptical confirmed rejections (Banff)
time to the first bioptical verified rejection

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Secondary Outcome

rate of patients with steroid-free immunosuppression
patient and graft survival rate
graft function (calculated by the Cock- croft-Gault and MDRD-IV formula respectively calculated creatinine clearance by the Nankivell formula respectively cystatin C measurement)
number of steroid-resistant rejections
blood pressure level and also amount and types of blood pressure medications
lipid levels and also amount and types of lipid-lowering medications
body weight, relative weight gain [kg], BMI
infection rate, infection type and infection severity
anaemia requiering erythropoetin treatment
PTLD incidence
tumor incidence
incidence of diabetes mellitus (ADA, venous fasting blood sugar >=7,0 mmol/L, pathological oGTT) and incidence of abnormal fasting blood sugar levels respectively of impaired glucose tolerance, incidence of a de novo insulin-requiriring or oral-antidiabetic-requiring treatment over >= 30 days
incidence of cataracts
incidence of avascular necrosis
incidence of osteoporosis (assessment of fracture rate and osteodensiometry)
wound healing disorders
incidence of chronic allograft nephropathy (CAN) with histology
incidence of CMV-disease (qPCR > 400 copies/µl)
incidence of BKV-disease (qPCR >10000 copies/µl)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2014/03/04
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   83   Years
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Additional Inclusion Criteria

Patients with kidney transplantation and taking part at the HARMONY-study
patients with a signed informed consent form

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Exclusion Criteria

Patient who are not able to realize nature, relevance and consequences of the clinical trial and who are not able to comply, to cooperate and communicate adequately and to follow the instructions of the study or even to give their informed consent

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Addresses

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    • Medizinische Fakultät C. G. Carus der TU Dresden
    • Mr.  Prof. Dr. med.  Christian  Hugo 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Medizinische Fakultät C. G. Carus der TU Dresden
    • Mr.  Prof. Dr. med.   Christian  Hugo 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Universitätsklinikum Freiburg, Allgemein- und Viszeralchirurgie
    • Mr.  Prof. Dr. med.  Oliver  Thomusch 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Fakultät C. G. Carus der TU Dresden
    • Mr.  Prof. Dr. med.  Christian  Hugo 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.