An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.

Study Overview
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Brief Summary
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A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure. Subjects meeting all inclusion and exclusion criteria were eligible to participate in this study. The treatment assignment was random and not chosen by the subject or their physician. Subjects were monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurred up to 12 months after transplant. 278 study subjects were enrolled at 28 transplant centers in the United States and Europe.

Official Title
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An Open-Label Prospective, Randomized, Multicenter Phase II Comparative Trial of Thymoglobulin® Versus Simulect® for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients

Conditions
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Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection, Induction Therapy

Intervention / Treatment
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* Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
* Drug: Simulect (basliximab)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient greater than or equal to 18 years old. Patient is classified as high risk for acute allograft rejection of DGF. Must have had at least 1 donor or 1 recipient variable for high risk. Patient will be a recipient of a solitary cadaveric renal allograft. Women of childbearing potential must have had a negative pregnancy test (serum or urine). Man or woman agrees to practice medically acceptable contraception (i.e. barrier or pharmacologic) for a minimum of 3 months following study drug administration. In addition, women were recommended to practice contraception for 1 year following transplantation, or per local standard. Patient agrees to participate in the study and sign an informed consent. Patient has no known contraindication to the administration of rabbit anti-thymocyte globulin or basiliximab. Patient has no history of hypersensitivity to basiliximab. Patient is dialysis-dependent at the time immediately prior to transplantation. Exclusion Criteria: Patient has received an investigational medication within the past 30 days. Patient has a history of malignancy within 2 years, with the exception of adequately treated localized squamous basal cell carcinoma of the skin without evidence of recurrence. Patient is currently abusing drugs or alcohol. Patient is known or suspected to have an active infection or be seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV). Patient is a multiple organ transplant recipient. Patient is on any type of immunosuppression (i.e. prior transplant recipient still on immunosuppression, or patient is receiving systemic steroids for any medical condition). Patient, who, in the opinion of the investigator, has significant medical or psychosocial problems or unstable disease states which would preclude enrollment. Examples of significant medical problems include, but are not limited to, morbid obesity or severe cardiac disease. Kidneys that are to be implanted en bloc or from donors less than 6 years old. Kidneys from donors that are known or suspected to have an active infection with or be seropositive for HBsAg, hepatitis B core antibody (HBcAb), HCV, or HIV. Kidneys from donors that have received investigational therapies designed to reduce the impact of ischemia reperfusion, DGF, or other donor-related immune events. Donor kidney is preserved by cold storage (with or without machine preservation) for less than 16 hours, with the exception of kidneys from non-heart-beating donors or kidneys from donors greater than 50 years old or donors with a SCr above 2.5mg/dL.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Control<br>Simulect (basiliximab) | Drug: Simulect (basliximab)<br>* 20 mg per day on 2 days<br>|
| Experimental: 2<br>Thymoglobulin (anti-thymocyte globulin (rabbit)) | Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]<br>* 1.5 mg/kg per day, for a maximum of 5 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-mo. safety & efficacy assessments including side effects and overall kidney transplant function. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-T cells antibodies, Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection, Induction Therapy