The Norwegian Pancreas Transplantation (PTx) Study

Launched by OSLO UNIVERSITY HOSPITAL · Oct 7, 2013

Keywords

ClinConnect Summary

The Norwegian Pancreas Transplantation (PTx) Study at Oslo University Hospital is an ongoing, one-center, observational study that follows adults who receive a pancreas transplant (with or without a kidney transplant). The researchers are comparing a newer, lower-dose steroid plan with the older, higher-dose steroid plan used in past patients to see if the lower steroids work as well for preventing rejection and if they cause fewer problems. They will also test new ways to watch for trouble after transplant, including special biopsies and immune tests from blood and tissue.

If you’re eligible, you would be adults 18–65 planning to receive a pancreas transplant (with or without a kidney transplant). Key inclusion: ability to consent, no current systemic infection, and acceptable surgical risk. Exclusions include active infections, unstable heart disease, recent cancer (within 5 years, with some skin cancers allowed), high risk antibody tests, or positive hepatitis B/C or HIV. About 60–80 patients are expected to enroll over 2–3 years, with a follow-up of up to 5 years. Participants will receive the standard four-drug immune therapy, but with the lower steroid dose, plus regular blood tests, scheduled biopsies at about 3 weeks, 6 weeks, and 12 months (and additional biopsies as needed), microdialysis monitoring near the pancreas graft, and periodic imaging. The study will look at acute rejection episodes, surgical and other complications, as well as graft and patient survival over time. Results have not yet been published.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years
• • Patients who receive a primary or secondary pancreas transplant, with or without a simultaneous kidney transplant (SPK).
• • Women who are of childbearing potential must have a negative serum pregnancy test at baseline.
• • Operability has to be ascertained by preoperative examination, performed by nephrologist, transplant surgeon and anaesthesiologist.
• • Signed and dated informed consent form.
• Exclusion Criteria:
• • Evidence of systemic infection
• • Presence of unstable cardiovascular disease.
• • Malignancy \< 5 years prior to entry into the trial (with the exception of adequately treated basal cell or squamous cell carcinomas of the skin).
• • Panel-reactive antibodies (PRA) \> 20% or the presence of donor-specific antigens (DSA).
• • Any positive test for HBV, HBC or HIV.