Trial document




drksid header

  DRKS00000858

Trial Description

start of 1:1-Block title

Title

Prospective Institutional review trial to test de novo sirolimus monotherapy following antithmocyte globin induction in kidney transplant recipients

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

Trial Acronym

[---]*

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

Kidney transplant recipients with immunological low-risk to a acute transplantat rejection receive a minimize immunsuppression. The patients undergo a immunsuppression with a polyclonal antibody (Thymoglobulin®, antibody against many defence cells in blood) following de novo sirolimus (Rapamune®) monotherapy.This immunosuppressive therapy should reduce the risk of chronic allograft nephropathy. In all, it can be expected, that the steroid- and CNI-free protocol will be the risk of cardiovascular events and the related mortality as well as the risk of opportunistic infection beneficially influenced.
The control group is a historic patient population. These patients received standard medication treatments for kidney transplant recipients: cyclosporin, mycophenolatmofetil and steroids.
Planned recruitment: 1.1. 2005 till 31.12.2006. Planned closure of follow-up: 2010.








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

Brief Summary in Scientific Language


Nonsensitized recipients of human leukocyte antigen-nonidentical postmortal kidney grafst will enrol in a prospective trial to test de novo sirolimus monotherapy following antithymocyte globin induction. This steroid- and CNI-free protocol should reduce the risk of cardiovascular events, chronic allograft nephropathy and the risk of opportunistic infection.

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

Organizational Data

  •   DRKS00000858
  •   2012/04/25
  •   2004/07/22
  •   yes
  •   Approved
  •   054/04, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   UKF000105  (Register klinischer Studien des Universitätsklinikums Freiburg)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   N18.8 -  Other chronic renal failure
  •   Z94.0 -  Kidney transplant status
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   15 well-selected immunologically low-risk patients receive a minimized immunsuppressive regime after kidney transplantation. The immunsupression starts with antithymocyte globin
    induction following de novo sirollmus monotherapy. This steroid- and CNI-free protocol should reduce the risk of cardiovascular events, chronic allograft nephropathy and the risk of opportunistic infection.
  •   Historic patient population treated with standard protocol: cyclosporine, mycophenolatmofetil, steroids
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Treatment
  •   Other
  •   III
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Transplant function (serum creatinine mg/dl and ceatinin-clearance) after 1, 3, 5 years

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

Secondary Outcome

• patient- and transplant survival
• rate and degree of acute bioptic confirmed graft shedding(after Banff) and number of steroid-resistant sheddings
• intake of calcineurin-inhibitors
• steroid long-term medication
• incidence of Chronic Allograft Nephropathy (CAN)
• level of blodd pressure and antihypertensive medication
• lipid level and lipid reducing medication
• liver function
• rate and degree of oppertunistic infections
• incidence of an haematological adverse effect
• incidence of malignant disease

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

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2005/01/26
  •   15
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- first kidney transplantation
- ager 18 - 65 years
- Written informed consent
- Highly effective contraception

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

Exclusion Criteria

- slave- or multi-transplantation
- combined transplantation
- age < 18 years
- incompatibility (allergy, intolerance, oversensitive) against study medication
- current malignant disease or last malignant disease< 5 years
- Serious intercurrent infections (uncontrolled or requiring treatment (incl. HIV)
- severe diarrhoea, vomiting or active gastric- or duodenal ulcer
- participation in another investigational sudy
- autoimmune disease as primary disease (collagen vascular diseases, colitis, HUS, SLE)
- primary disease focal-sclerotising glomerulonephritis
- disease, which need temporary or permanent treatment with cortisone (also inhalatory medicines)
-severe fat metabolic disturbance (cholesterine > 300 mg/dl, triglycerides > 400 mg/dl)
- Epstein-Barr-virus IgG negative
- chronic hepatitis B and hepatitis C infection
- thrombocytopenia < 50.000 tsd/µl
-coagulopathies ( lack of or a defect in v. Willebrand factor, hemophilia, lack of protein S lack of protein C )

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg Klinik für Allgemein und Vizeralchirurgie
    • Hugstetter Str. 55
    • D-79106  Freiburg
    • 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 scientific-contact
    • Abt. Allgemein- und Viszeralchirurgie
    • Mr.  Prof.  Oliver  Thomusch 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • 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
    • Abt. Allgemein- und Viszeralchirurgie
    • Mr.  Prof.  Oliver  Thomusch 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • 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
    • Universitätsklinik Freiburg
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting stopped after recruiting started
  •   2005/11/29
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.