Comparison between a low-dose and a high-dose immunosuppressive regimen in pancreas transplantatio

• Conditions: The only indication for pancreas-transplantation (PTx) is advanced and/or badly controlled diabetes mellitus. Patients who have developed renal insufficiency due do diabetic nephropathy may be candidates for combined kidney- and pancreas-transplantation (SPK). While patients with brittle diabetes (without kidney failure), involving severe hypoglycemic episodes and unawareness, may be candidates for solitary PTx. Anyway, high-levelled immunosuppression will be needed after PTx/SPK.; MedDRA version: 14.1Level: PTClassification code 10052278Term: Renal and pancreas transplantSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2012-005335-83-NO
• Lead Sponsor: Oslo University Hospital Rikshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-12
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 preop. examination, performed by nephrologist,
transplant surgeon and anaesthesiologist.
- Signed and dated informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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).
- Use of investigational agents <1 month prior to entry into the trial.
- Any positive test for HBV, HBC or HIV.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified