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

A Randomized Open-label Study: Efficacy and safety of basiliximab combined with tacrolimus, mycophenolate and low-dose corticosteroids vs thymoglobulin, tacrolimus, mycophenolate and high-dose corticosteroids in Pancreatic Allograft Recipients - The Norwegian pancreas-Tx study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005335-83-NO

Enrollment

Registered

2012-12-12

Start date

2013-04-05

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 ve

Interventions

Trade Name: Simulect Pharmaceutical Form: Powder and solvent for solution for injection/infusion Trade Name: Solu-Medrol Pharmaceutical Form: Powder for solution for injection/infusion Trade Name: P

Eligibility

Sex/Gender

All

Inclusion 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 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

Exclusion criteria: - Evidence of systemic infection. - Presence of unstable cardiovascular disease. - Malignancy 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Several studies have shown acceptable results after Pancreas transplantation (PTx) by substituting ATG with basiliximab, which is considered to convey a considerably lower number of adverse events. However, the issue of ATG vs basiliximab in PTx has not yet been solved. The potential advantages of reducing the overall cortiocosteroid (CS) load is obvious, as CS is a well-known pro-diabetic agent and causes severe long term adverse effects. On this background, we intend to investigate a PTx low-grade immunosuppressive protocol, with Basiliximab and low-dose CS versus the conventional protocol with ATG and high-dose CS. The primary aim will be to monitor the incidence of rejections, with particular attention to the low-immunosppressive arm. Furtehermore, we will look for a potential benefit regarding the rate of surgical complications in the low-immunosppressive arm.;Secondary Objective: •Compare the number and severity of rejection episodes in the pancreas allograft to the ones occurring in the kidney allograft (SPK), and the ones diagnosed by the duodenal segment biopsies. •Compare pancreas graft survival between the study groups. •Monitor kidney (and pancreas) graft survival in SPK. •Compare patient survival between the study groups. •Compare the incidence of non-surgical complications (infections, cardial complications, pulmonary complications and neurological complications). •Analyse possibly useful non-invasive markers of rejection (amylase, C-peptide etc).;Primary end point(s): 1. The incidence of acute rejection episodes at 6, 12, 36 and 60 months after pancreas transplantation, between two quadruple immunosuppressive regimens; basiliximab combined with tacrolimus, mycophenolate and low-dose corticosteroids vs thymoglobulin, tacrolimus, mycophenolate and high-dose corticosteroids. The incidence of rejection is defined as the fraction of patients in which rejections episodes (one or more) hve been proven by biopsi	—

Measure

Time frame

Main Objective: Several studies have shown acceptable results after Pancreas transplantation (PTx) by substituting ATG with basiliximab, which is considered to convey a considerably lower number of adverse events. However, the issue of ATG vs basiliximab in PTx has not yet been solved. The potential advantages of reducing the overall cortiocosteroid (CS) load is obvious, as CS is a well-known pro-diabetic agent and causes severe long term adverse effects. On this background, we intend to investigate a PTx low-grade immunosuppressive protocol, with Basiliximab and low-dose CS versus the conventional protocol with ATG and high-dose CS. The primary aim will be to monitor the incidence of rejections, with particular attention to the low-immunosppressive arm. Furtehermore, we will look for a potential benefit regarding the rate of surgical complications in the low-immunosppressive arm.;Secondary Objective: •Compare the number and severity of rejection episodes in the pancreas allograft to the ones occurring in the kidney allograft (SPK), and the ones diagnosed by the duodenal segment biopsies. •Compare pancreas graft survival between the study groups. •Monitor kidney (and pancreas) graft survival in SPK. •Compare patient survival between the study groups. •Compare the incidence of non-surgical complications (infections, cardial complications, pulmonary complications and neurological complications). •Analyse possibly useful non-invasive markers of rejection (amylase, C-peptide etc).;Primary end point(s): 1. The incidence of acute rejection episodes at 6, 12, 36 and 60 months after pancreas transplantation, between two quadruple immunosuppressive regimens; basiliximab combined with tacrolimus, mycophenolate and low-dose corticosteroids vs thymoglobulin, tacrolimus, mycophenolate and high-dose corticosteroids. The incidence of rejection is defined as the fraction of patients in which rejections episodes (one or more) hve been proven by biopsi

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Secondary

Measure	Time frame
Secondary end point(s): 1. The number and severity of rejection episodes in the pancreas allograft compared to the ones occurring in the kidney allograft (SPK), and the ones diagnosed by the duodenal segment biopsies. 2. Pancreas graft survival. 3. Kidney- (and pancreas) graft survival in SPK. 4. Patient survival. 5. The incidence of non-surgical complications (infections, cardial complications, pulmonary complications and neurological complications). 6. Non-invasive markers of rejection (amylase, C-peptide etc).;Timepoint(s) of evaluation of this end point: 1. Evaluated 12 months post-Tx. 2. Evaluated 12, 36 and 60 months post-Tx. 3. Evaluated 12, 36 and 60 months post-Tx. 4. Evaluated 12, 36 and 60 months post-Tx. 5. Evaluated 12 and 60 months post-Tx. 6. Evaluated 12 months post-Tx (by blood samples taken daily for the first 14 days, thereafter 3 times/week until week 10.	—

Measure

Time frame

Secondary end point(s): 1. The number and severity of rejection episodes in the pancreas allograft compared to the ones occurring in the kidney allograft (SPK), and the ones diagnosed by the duodenal segment biopsies. 2. Pancreas graft survival. 3. Kidney- (and pancreas) graft survival in SPK. 4. Patient survival. 5. The incidence of non-surgical complications (infections, cardial complications, pulmonary complications and neurological complications). 6. Non-invasive markers of rejection (amylase, C-peptide etc).;Timepoint(s) of evaluation of this end point: 1. Evaluated 12 months post-Tx. 2. Evaluated 12, 36 and 60 months post-Tx. 3. Evaluated 12, 36 and 60 months post-Tx. 4. Evaluated 12, 36 and 60 months post-Tx. 5. Evaluated 12 and 60 months post-Tx. 6. Evaluated 12 months post-Tx (by blood samples taken daily for the first 14 days, thereafter 3 times/week until week 10.

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Countries

Norway

Contacts

Public ContactOle Øyen

Oslo University Hospital Rikshospitalet

ole.oyen@rikshospitalet.no4723070686

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026