Trial document




drksid header

  DRKS00000441

Trial Description

start of 1:1-Block title

Title

Extracorporeal liver support therapy with Prometheus in patients with hepato-renal syndrome

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

LUTHER pilot study

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The study investigates patients with hepato-renal syndrome (kidney failure on the basis of liver failure), comparing additional extracorporeal liver support therapy (liver dialysis) with medical standard treatment. Primary endpoint of the study is kidney function on day 15 of study therapy.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Hepato-renal syndrome (HRS) is a potentially reversible form of acute kidney injury on the basis of acute or chronic liver failure. Many patients with HRS eventually require dialysis therapy. As the prognosis of HRS is poor there is an urgent need for improved therapeutic concepts. Prometheus is a novel extracorporeal liver support system using fractionated plasma filtration and adsorption (FPSA) to remove metabolic waste products and toxins that accumulate in patients' blood as s consequence of liver failure. At the same time the therapy includes conventional high-flux dialysis for the removal of water soluble, small molecular weight compounds. This prospective, randomised pilot study sets out to investigate if additional extracorporeal liver support therapy with Prometheus results in better renal outcomes (kidney function at day 15 of study) compared to patients receiving medical standard treatment.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000441
  •   2010/06/08
  •   [---]*
  •   yes
  •   Approved
  •   EA2/054/09, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1115-4645 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   K76.7 -  Hepatorenal syndrome
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   standard medical therapy (vasopressors: Terlipressin 4x1-2 mg/day or Noradrenalin; human serum albumin 20-40 g/die)
  •   standard medical therapy plus 5-8 treatments with Prometheus FPSA (up to daily FPSA treatment on day 1-8, 4-6 hours each)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   [---]*
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Kidney function (glomerular filtration rate, GFR) on day 15 of study

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

renal replacement therapy; urine volume; body weight; urinary sodium output; serum sodium concentration; MELD Score; degree of encephalopathy

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2010/06/05
  •   40
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

hepato-renal syndrome; informed consent (by patient or legal representative); absence of exclusion criteria

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

acive bleeding complications; severe thrombocytopenia (platelets < 20,000/µl); participation in other study within the last 3 months.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité-Universitätsmedizin Berlin Med. Klinik m.S. Nephrologie und internistische Intensivmedizin
    • Mr.  Prof. Dr. med.  Achim  Jörres 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address secondary-sponsor
    • E.N.D.I.-Stiftung
    • Else-Kröner-Str. 1
    • 61346  Bad Homburg
    • Germany
    end of 1:1-Block address secondary-sponsor
    start of 1:1-Block address contact secondary-sponsor
    •   +49 6172 609 8290
    •   +49 6172 6098382
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact secondary-sponsor
  • start of 1:1-Block address scientific-contact
    • Charité-Universitätsmedizin Berlin Med. Klinik m.S. Nephrologie und internistische Intensivmedizin
    • Mr.  Prof. Dr. med.  Achim  Jörres 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Charité-Universitätsmedizin Berlin Med. Klinik m.S. Nephrologie und internistische Intensivmedizin
    • Mr.  Prof. Dr. med.  Achim  Jörres 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • E.N.D.I.-Stiftung
    • Else-Kröner-Str. 1
    • 61346  Bad Homburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   +49 6172 609 8290
    •   +49 6172 6098382
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.