Trial document




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  DRKS00000528

Trial Description

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Title

Pilot Study for the Evaluation of Islet-after-Kidney Transplantation in Subjects with Type I Diabetes

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Trial Acronym

Islet-after-Kidney

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Patients with type 1 diabetes need lifetime insulin therapy since their insulin producing ß-cells within pancreatic Langerhans islets are destroyed by autoimmune attack. With duration and severity of the disease and even under modern insulin therapy, patients develop severe diabetic complications like kidney failure. This scenario is frequent in diabetics with hardly adjustable blood sugar levels (brittle diabetes), who suffer from severe hypoglycaemic episodes. This study investigates whether transplantation of isolated pancreatic donor islets of Langerhans can durably restore physiologic blood sugar levels in type I diabetics with transplanted kidney and hardly adjustable blood sugar levels.

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Brief Summary in Scientific Language

This proposed pilot study is monocentric, open and one armed prospective. It will evaluate whether the transplantation of Langerhans donor islets are an adequate procedure to achieve physiological endogenous insulin function in kidney transplanted type 1 diabetics with hardly adjustable blood glucose levels. In particular, existing procedures should be evaluated and optimised since to date islet transplantation-achieved insulin independence is not durable and many patients have to additionally inject moderate amounts of insulin in the long run.

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Organizational Data

  •   DRKS00000528
  •   2010/08/30
  •   2005/10/14
  •   yes
  •   Approved
  •   23/05, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  •   U1111-1116-6534 
  •   UKF000524  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   E10.7 -  Insulin-dependent diabetes mellitus; With multiple complications
  •   Z94.0 -  Kidney transplant status
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Interventions/Observational Groups

  •   Percutananeous infusion of isolated islets via the portal vene into the liver

    Aim >10.000 IEq / kg BW (in multiple transplantations)

    > 300.000 IEq per transplantation
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
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Primary Outcome

Insulin independence after single or if necessary multiple islet transplantations

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Secondary Outcome

Improved blood glucose control and reduced hypoglycaemia unawareness resulting in reduced hypoglycaemic episodes

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2010/08/28
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

(1) over 5 years diabetes type 1 with secondary complications (2) kidney transplantation or combined pancreas-kidney transplantation with failure of the transplanted pancreas

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Exclusion Criteria

a) Severe corneal disease:
- Myocardial infarction during the last 6 months
- non correctable coronary heart disease
b) alcohol- or drug (incl. nicotine) abuse
c) Psychiatric disease
d) History of non-compliance to prescribed drugs
e) Active infection
f) Cancer
g) BMI >26kg/m2; BW > 70kg (women), 75kg (man)
h) Positive C-peptide answer to arginine stimulus
i) Non signed „informed consent“ form
j) Age <18 and >65 years
k) Elevated liver enzymes
l.) gallstones
m) Haemangioma of the liver
n) Untreated proliferative retinopathy
o) Gravidity
p) Sensitisation by prior transplantation (PRA-testing)
q) Demand of insulin > 0.7 IU/kg/day
r) HbA1C >12%
s) Ability not to reach the university hospital Freiburg during 12 hours
t) Untreated hyperlipidemia
u) Further treatment with steroids
v) Marcumar therapy
w) Morbus Addison
x) Kidney transplantation < 12 months
y) Creatinin-Clearance < 40 ml/min
z) Deterioration of the kidney function

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Addresses

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    • Universitätsklinikum Freiburg Komm. Leitender Ärztlicher Direktor, Vorstandsvorsitzender
    • Mr.  Professor Dr. Dr. h.c.   J. Rüdiger   Siewert  
    • Hugstetter Strasse 49
    • 79106  Freiburg
    • Germany
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  • start of 1:1-Block address secondary-sponsor
    • [---]*
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    • Uniklinik Freiburg; Innere Med. II, Schwerpunkt Endokrinologie/Diabetologie
    • Mr.  Prof. Dr. med.  J.  Seufert 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg; Innere Med. II, Schwerpunkt Endokrinologie/Diabetologie
    • Mr.  Dr. med.  N.  Perakakis 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg; Innere Med. II, Schwerpunkt Endokrinologie/Diabetologie
    • Mr.  Prof. Dr. med.  J.  Seufert 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    • Uniklinik Freiburg; Abt. für Allgemein und Viszeralchirurgie
    • Mr.  Prof. Dr. Dr.   U. T.  Hopt 
    • Hugstetter Strasse 55
    • 79106  Freiburg
    • Germany
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    •   0761-270-2806
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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