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Extended Pancreas Donor Program - The EXPAND Study (EXPAND)

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ClinicalTrials.gov Identifier: NCT01384006
Recruitment Status : Unknown
Verified June 2011 by University of Regensburg.
Recruitment status was:  Recruiting
First Posted : June 28, 2011
Last Update Posted : July 4, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
To expand the donor pool for pancreas allografts. For detailed description please see below.

Condition or disease
Pancreas Allograft Recipients w/wo Kidney Transplantation

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 110 participants
Time Perspective: Prospective
Official Title: EXTENDED PANCREAS DONOR PROGRAM - THE EXPAND STUDY
Study Start Date : June 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Control
standard pancreas allograft recipients
Study
recipients of extended donor criteria pancreas allografts


Outcome Measures

Primary Outcome Measures :
  1. Pancreas allograft survival at 3 months after transplantation [ Time Frame: 3 months ]
    Pancreas allograft survival at 3 months after transplantation has been defined as primary endpoint. Patients that are insulin-free and have a normal fasting glucose level 60 - 140 mg/dl (3.3 - 7.8 mmol/l) in peripheral venous blood are regarded as having a functioning organ. Thus, all patients that have a pathologic fasting glucose level at 3 months will be counted as event with regards to the primary endpoint of pancreas allograft survival.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pancreas allograft recipients in Germany
Criteria

Inclusion Criteria:

  • Recipients of standard allocation organs or
  • Recipients of organs from donors between 50 to 60 years OR a BMI 30-34
  • CIT (cold ischemic time) ≤ 12h (only local allocation of organs, optimally the procuring surgical team should be the transplanting team).

and

  • negative cross-match
  • age > 18 years
  • primary SPK, PAK or PTA
  • Patients on standardized immunosuppressive treatment with Tacrolimus (Prograf®), MPA (Myfortic®) [aiming at center specific trough-level practice] from day 5 after transplantation (prior to day 5 MMF (Cell Cept®) can be applied as i.v. medication due to reduced gastrointestinal passage and insecure absorption of orally applied medication) and center-specific steroid treatment.

Exclusion Criteria:

  • Malignant diseases within 5 years prior to PTA/SPK except for squamous cell carcinoma and basalioma of the skin.
  • Pancreas retransplantation.
  • Immunized patients with a preformed antibody titer>5%.
  • Women with child bearing potential.
  • Patients with a psychological, familial, sociologic or geographic condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Patients under guardianship (e.g. individuals who are not able to freely give their informed consent).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384006


Contacts
Contact: Stefan A Farkas, MD +49-941-944 ext 6813 stefan.farkas@klinik.uni-r.de
Contact: Andreas A Schnitzbauer, MD +49-941-944 ext 6915 andreas.schnitzbauer@klinik.uni-r.de

Locations
Germany
Regensburg University Hospital Recruiting
Regensburg, Bavaria, Germany, 93053
Contact: Andrea Proneth, MD    +49-941-944 ext 0    andrea.proneth@klinik.uni-r.de   
Contact: Susanne Melter    +49-941-944 ext 6770    susanne.melter@klinik.uni-r.de   
Sponsors and Collaborators
University of Regensburg
Charite University, Berlin, Germany
Ludwig-Maximilians - University of Munich
University of Jena
Johann Wolfgang Goethe University Hospital
University Hospital Tuebingen
University Hospital Erlangen
University of Heidelberg Medical Center
University of Leipzig
University Hospital Dresden
University Hospital Bergmannsheil Bochum
Hannover Medical School
Universitätsklinikum Hamburg-Eppendorf
University of Kiel
Transplantationszentrum Köln-Merheim
Investigators
Study Director: Stefan A Farkas, MD Regensburg Univeristy Hospital
Principal Investigator: Andreas A Schnitzbauer, MD Regensburg University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regensburg University Hospital, UKR
ClinicalTrials.gov Identifier: NCT01384006     History of Changes
Other Study ID Numbers: EXPAND
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: June 2011

Keywords provided by University of Regensburg:
Pancreas transplantation
extended donor criteria
organ survival

Additional relevant MeSH terms:
Pancrelipase
Pancreatin
Gastrointestinal Agents