Extended Pancreas Donor Program - The EXPAND Study
This study is currently recruiting participants.
Verified June 2011 by University of Regensburg
Sponsor:
University of Regensburg
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
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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
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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013