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Extended Pancreas Donor Program - The EXPAND Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of Regensburg.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Charite University, Berlin, Germany
Ludwig-Maximilians - University of Munich
University of Jena
Johann Wolfgang Goethe University Hospitals
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
Information provided by:
University of Regensburg
ClinicalTrials.gov Identifier:
NCT01384006
First received: June 27, 2011
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

To expand the donor pool for pancreas allografts. For detailed description please see below.


Condition
Pancreas Allograft Recipients w/wo Kidney Transplantation

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: EXTENDED PANCREAS DONOR PROGRAM - THE EXPAND STUDY

Resource links provided by NLM:


Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Pancreas allograft survival at 3 months after transplantation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 110
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
standard pancreas allograft recipients
Study
recipients of extended donor criteria pancreas allografts

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitals
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

No publications provided

Responsible Party: Regensburg University Hospital, UKR
ClinicalTrials.gov Identifier: NCT01384006     History of Changes
Other Study ID Numbers: EXPAND
Study First Received: June 27, 2011
Last Updated: June 30, 2011
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Pancreatin
Pancrelipase
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014