De Novo Everolimus-based Therapy for Renal Transplantation Using Rituximab Induction

• Status: Terminated
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesized that everolimus-based immunosuppressive therapy combined with rituximab induction could provide comparable safety profiles for renal transplant patients, as compared to standard immunosuppressive therapy using thymoglobulin induction, tacrolimus, mycophenolate mofetil and steroids, in terms of acute rejection rate and renal function.

Rituximab was reported to reverse refractory acute kidney transplant rejection. Combined with immunoadsorption with or without IVIG, rituximab could successfully prevent antibody-mediated rejection in ABO-incompatible renal transplantation. This study is to assess whether a CNI-free regimen including B-cell depleting antibody induction, everolimus and MMF results in comparable long-term function without a negative impact on safety or efficacy of immunosuppression. This study will be open-label and two-arm randomized (2:1).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Everolimus; Immunosuppressive Agents; Rituximab; Sirolimus; Tacrolimus; Thymoglobulin

Criteria

Inclusion Criteria:

• Male or female patients at 15-65 years of age undergoing renal transplantation

• Patients who have been informed of the potential risks and side effects of the study

• Patients who have given written informed consent to participate in the study

• Females who are not pregnant or nursing women (pregnancy test required)

Exclusion Criteria:

• Donor age greater than 65 years

• Patients receiving a perfectly matched kidney (6 matches HLA A, B, DR)

• Patients who are recipients of multiple solid organ transplants

• Patients undergoing second or subsequent transplantation

• Patients with pre-transplant PRA > 30%

• Patients with ABO incompatibility or positive lymphocytotoxicity

• Patients with severe, active infection

• Patients who have an abnormal liver profile such as ALT, AST, alkaline phosphatase or total bilirubin >3 times the upper normal limit

• Patient who are HIV-positive or hepatitis C (PCR+ only) B surface antigen positive

• Patients who have been treated with an investigational drug or therapy within one month prior to entry or who will be so treated within 6 months of transplantation

• Patients with a history of malignancy within the last five years except excised squamous or basal cell carcinoma

• Patients with a history of alcohol or drug abuse or signs of alcohol-induced organ damage, mental dysfunction or other factors limiting their ability to comply fully with the study requirements.