Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Prospective Randomized Study on the Efficacy and Safety of the Prophylactic Use of Rituximab, Added to Standard Immunosuppressive Treatment in Comparison With Standard Immunosuppressive Treatment Alone in Renal Transplantation
Brief Summary: Our standard immunosuppressive treatment after renal transplantation is a combination of tacrolimus, mycophenolate mofetil, and prednisolone. With this regimen the incidence of acute rejection within the first six months after transplantation has dropped to about 20%. The main challenge at present remains to improve long-term outcome by preventing chronic allograft nephropathy (CAN). Since acute rejection is a strong predictor of CAN, a further decrease in the incidence of acute rejection can improve the long-term graft survival. Current strategies to prevent rejection are mainly directed at alloreactive T cells. Recently, the attention for the role of antibodies in the pathogenesis of acute rejection has increased. In addition, anti-B cell therapy was shown to be effective in diseases that were considered to be mainly T cell driven, like rheumatoid arthritis. In the latter case it has been suggested that anti-B cell antibodies may impair the antigen presenting function of B cells. We therefore decided to investigate the effectiveness and safety of the anti-B cell monoclonal antibody rituximab for prophylaxis of acute rejection after renal transplantation.

Study design: Double-blind, placebo controlled intervention study. One group receives a single dose of rituximab of 375 mg/m2 intravenously at the time of transplantation, and the other group receives a placebo infusion.

Primary Objective:

To determine the incidence and severity of biopsy-confirmed acute rejection within the first six months after transplantation.

Secondary Outcomes:

* Renal function as estimated by the endogenous creatinine clearance at 6 months
* Occurrence of chronic allograft nephropathy at 6 months
* Cumulative incidence of infections and malignancies at 6 months
* Medical costs during the first 6 months after transplantation
* Patient and graft survival


Options:
A: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Thymoglobulin | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: Campath-1H | Arm Label: C; Type: EXPERIMENTAL; Interventions: Drug: Daclizumab | Intervention Type: DRUG; Name: Thymoglobulin; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Campath-1H; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Daclizumab; Assigned to Arm(s): C
B: Arm Label: Single-dose Thymoglobulin; Type: EXPERIMENTAL; Interventions: Biological: Single-dose rabbit Anti-thymocyte Globulin induction | Arm Label: Divided-dose Thymoglobulin; Type: ACTIVE_COMPARATOR; Interventions: Biological: Divided-dose rabbit Anti-thymocyte Globulin induction | Intervention Type: BIOLOGICAL; Name: Single-dose rabbit Anti-thymocyte Globulin induction; Assigned to Arm(s): Single-dose Thymoglobulin | Intervention Type: BIOLOGICAL; Name: Divided-dose rabbit Anti-thymocyte Globulin induction; Assigned to Arm(s): Divided-dose Thymoglobulin
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Rituximab | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Rituximab; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2
D: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Tacrolimus/Sirolimus | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: Tacrolimus/MMF | Arm Label: C; Type: EXPERIMENTAL; Interventions: Drug: Neoral/Sirolimus | Intervention Type: DRUG; Name: Tacrolimus/Sirolimus; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Tacrolimus/MMF; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Neoral/Sirolimus; Assigned to Arm(s): C

Answer: C