NCT00859131
Completed
Not Applicable
Rabbit Anti-thymocyte Globulin Versus IL2 Receptor Antagonists in Combination With Tacrolimus, Corticosteroids and Mycophenolate Mofetil in a Predominantly High Risk Kidney Transplant Population.
Medical University of South Carolina1 site in 1 country200 target enrollmentStarted: March 2009Last updated:
ConditionsEnd Stage Renal Disease
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of induction therapy with Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).
Detailed Description
A 12 month, prospective, randomized, single center, open-label study to evaluate the safety and efficacy of Rabbit anti-thymocyte globulin versus IL2 receptor antagonists in combination with tacrolimus, corticosteroids and mycophenolate mofetil in a predominantly high risk kidney transplant population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients between 18 and 75 years of age
- •Male or female patients who are primary or repeat cadaveric, living unrelated or non- Human leukocyte antigen (HLA) identical living related donor renal transplant recipients
- •Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to study inclusion.
- •The patient has given written informed consent to participate in the study
Exclusion Criteria
- •Patient has previously received or is receiving an organ transplant other than a kidney.
- •Patients who are recipients of a multiple organ transplant.
- •Patient has received a primary or re-transplant from an HLA-identical living donor.
- •Any positive cross-match.
- •Patient is the recipient of a pediatric donor kidney from a pediatric donor aged 8 years or less.
- •Patient has received an ABO incompatible donor kidney.
- •Recipient or donor is known to be seropositive for hepatitis C virus (HCV) or B virus (HBV) except for hepatitis B surface antibody positive.
- •Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
- •Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
- •Patients with thrombocytopenia (\<75,000/mm3 ), with an absolute neutrophil count of \< 1,000/mm3); and/or leucopoenia (\< 2,000/mm3), or anemia (hemoglobin \< 6 g/dL) prior to study inclusion.
Arms & Interventions
Thymoglobulin
Active Comparator
Subjects receiving Thymoglobulin as induction agent in renal transplantation
Intervention: Rabbit Antithymocyte globulin (Drug)
Zenapax
Active Comparator
subject who will receive daclizumab or basiliximab as induction agent in renal transplantation
Intervention: Daclizumab (Drug)
Outcomes
Primary Outcomes
Treatment Efficacy Will be Defined as the Number of Patients With Biopsy Proven Acute Rejection at One Year Post-transplant.
Time Frame: One year
Secondary Outcomes
- Incidence of Thrombocytopenia, Defined as a Platelet Count of Less Than 100,000 Cells/mm3(One year)
- Graft Survival at One Year Post-transplant(One year)
- Incidence of Post-transplant Malignancies, Including Post-transplant Lymphoproliferative Disease (PTLD) and Skin Cancers.(One year)
- Number of Patients Requiring Antilymphocyte Therapy for Acute Rejection.(One year)
- Incidence of Post-transplant Infections, Including, But Not Limited to, CMV Infection and Disease, BK Infection and Nephropathy, Other Opportunistic Infections, Urinary Tract Infections, Pneumonia, and Sepsis(one year)
- Incidence of Leukopenia, Defined as a Total White Blood Cell Count of Less Than 2,000 Cells/mm3(One year)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 2
Prospective Phase II Study of Rabbit Antithymocyte Globulin (ATG, Thymoglobuline®, Genzyme) With Ciclosporin for Patients With Acquired Aplastic AnaemiaAcquired Aplastic AnaemiaNCT01530555King Faisal Specialist Hospital & Research Center35
Completed
Phase 2
Rabbit Antithymocyte Globulin (Thymoglobuline) With Ciclosporin for Patients With Acquired Aplastic AnaemiaAplastic AnemiaNCT00471848European Society for Blood and Marrow Transplantation35
Completed
Phase 1
Antithymocyte Globulin and Sirolimus in Treating Patients With Relapsed Multiple MyelomaDrug/Agent Toxicity by Tissue/OrganMultiple Myeloma and Plasma Cell NeoplasmNCT00317798University of Rochester18
Unknown
Phase 3
Thymoglobulin Induction in Kidney Transplant RecipientsKidney TransplantationIschemia-Reperfusion InjuryNCT01239563University of Oxford40
Completed
Phase 1
Immunomodulatory Therapy for Recently Onset Type 1 DiabetesType 1 diabetesJPRN-jRCTs031180089CHUJO DAISUKE12