Extended Pancreas Donor Program - The EXPAND Study

NCT01384006 | Unknown DMC

• 1 other identifier: EXPAND
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreas Allograft Recipients w/wo Kidney Transplantation

Keywords

Pancreas transplantation; extended donor criteria; organ survival

Outcome Measures

Primary Outcomes (1)

• Pancreas allograft survival at 3 months after transplantation

  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.

  3 months

Study Arms (2)

Control

standard pancreas allograft recipients

Study

recipients of extended donor criteria pancreas allografts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pancreas allograft recipients in Germany

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Regensburg: lead
• Charite University, Berlin, Germany: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• University of Jena: collaborator
• Johann Wolfgang Goethe University Hospital: collaborator
• University Hospital Tuebingen: collaborator
• University Hospital Erlangen: collaborator
• University of Heidelberg Medical Center: collaborator
• University of Leipzig: collaborator
• University Hospital Dresden: collaborator
• University Hospital Bergmannsheil Bochum: collaborator
• Hannover Medical School: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University of Kiel: collaborator
• Transplantationszentrum Köln-Merheim: collaborator

Study Sites (1)

Regensburg University Hospital

Regensburg, Bavaria, 93053, Germany

RECRUITING

Related Publications (2)

• Proneth A, Schnitzbauer AA, Schenker P, Wunsch A, Rauchfuss F, Arbogast H, Manekeller S, Nadalin S, Heise M, Strohlein MA, Banas B, Schemmer P, Becker T, Bechstein WO, Pascher A, Viebahn R, Geissler EK, Schlitt HJ, Farkas SA. Extended Pancreas Donor Program-The EXPAND Study: A Prospective Multicenter Trial Testing the Use of Pancreas Donors Older Than 50 Years. Transplantation. 2018 Aug;102(8):1330-1337. doi: 10.1097/TP.0000000000002122.

  PMID: 29406443 DERIVED

• Proneth A, Schnitzbauer AA, Zeman F, Foerster JR, Holub I, Arbogast H, Bechstein WO, Becker T, Dietz C, Guba M, Heise M, Jonas S, Kersting S, Klempnauer J, Manekeller S, Muller V, Nadalin S, Nashan B, Pascher A, Rauchfuss F, Strohlein MA, Schemmer P, Schenker P, Thorban S, Vogel T, Rahmel AO, Viebahn R, Banas B, Geissler EK, Schlitt HJ, Farkas SA. Extended pancreas donor program - the EXPAND study rationale and study protocol. Transplant Res. 2013 Jul 1;2(1):12. doi: 10.1186/2047-1440-2-12.

  PMID: 23816330 DERIVED

Study Officials

• Stefan A Farkas, MD

  Regensburg Univeristy Hospital

  STUDY DIRECTOR

• Andreas A Schnitzbauer, MD

  Regensburg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan A Farkas, MD

CONTACT

+49-941-944; stefan.farkas@klinik.uni-r.de

Andreas A Schnitzbauer, MD

CONTACT

+49-941-944; andreas.schnitzbauer@klinik.uni-r.de

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: July 4, 2011

Record last verified: 2011-06

Locations

DE (1)