Safety and Efficacy Study of Thymoglobulin Versus Zenapax - Full Text View

Sponsors and Collaborators:	Medical University of South Carolina Genzyme
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00859131

Purpose

The purpose of this study is to evaluate the safety and efficacy of induction therapy with Thymoglobulin in comparison with Zenapax.

Condition	Intervention
End Stage Renal Disease	Drug: Rabbit Antithymocyte globulin Drug: Daclizumab

MedlinePlus related topics: Cholesterol

Drug Information available for: Dacliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12 Month Study to Evaluate the Safety and Efficacy of Rabbit Anti-Thymocyte Globulin Versus Daclizumab in Combination With Tacrolimus, Corticosteroids and Mycophenolate Mofetil in High Risk Kidney Transplant Population.

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

Treatment efficacy will be defined as the incidence of all biopsy proven acute rejection and calculated creatinine clearance using the abbreviated MDRD equation at one year post-transplant. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the safety and tolerability of rabbit anti-thymocyte globulin or daclizumab in combination with tacrolimus, corticosteroids and mycophenolate mofetil. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Proportion of patients requiring antilymphocyte therapy for acute rejection. [ Time Frame: One year ] [ Designated as safety issue: No ]
Patient and graft survival at one year post-transplant [ Time Frame: One year ] [ Designated as safety issue: No ]
Incidence of post-transplant diabetes mellitus (PTDM), defined as post-discharge new need for insulin or oral hypoglycemic agents and meeting current ADA diagnostic criteria for diabetes mellitus [ Time Frame: One year ] [ Designated as safety issue: No ]
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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Patient weight change [ Time Frame: one year ] [ Designated as safety issue: No ]
Incidence and severity of hypercholesterolemia (total cholesterol, HDL cholesterol, LDL cholesterol) and hypertriglyceridemia and treatment of hyperlipidemia, as defined in NCEP III guidelines [ Time Frame: One year ] [ Designated as safety issue: No ]
Incidence of post-transplant malignancies, including post-transplant lymphoproliferative disease (PTLD) and skin cancers. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Incidence of leukopenia, defined as a total white blood cell count of less than 2,000 cells/mm3 and neutropenia, defined as an absolute neutrophil count of less than 1,000 cells/mm3 and need for colony stimulating factors [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Incidence of thrombocytopenia, defined as a platelet count of less than 100,000 cells/mm3 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Incidence of anemia, defined as a hemoglobin of less than 10 g/dL and need for erythropoietin or similar agents [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Determine the impact of genotyping using microarray analysis on clinical outcomes and histologic findings [ Time Frame: One year ] [ Designated as safety issue: No ]
Utilizing the EuroQoL survey, determine if there is a correlation between graft function and quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Thymoglobulin: Active Comparator Subjects receiving Thymoglobulin as induction agent in renal transplantation	Drug: Rabbit Antithymocyte globulin 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4
Zenapax: Active Comparator subject who will receive Zenapax as induction agent in renal transplantation	Drug: Daclizumab 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7

Detailed Description:

A 12 month, prospective, randomized, single center, open-label study to evaluate the safety and efficacy of Rabbit anti-thymocyte globulin versus daclizumab in combination with tacrolimus, corticosteroids and mycophenolate mofetil in a predominantly high risk kidney transplant population.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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:

Recipients of extended criteria donor kidneys.
- Donors 60 years of age or older
- Donors 50 years of age or older with two of the following:
Terminal serum creatinine equal to or older than 1.5 mg/dL
History of hypertension
Death due to cerebral vascular accident
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.
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.
Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, daclizumab or corticosteroids.
Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.
Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.
Women of childbearing potential must use two reliable forms of contraception simultaneously, unless they are status post bilateral tubal ligation, bilateral oophorectomy, or hysterectomy. Effective contraception must be used before beginning study drug therapy, for the duration of the study and for 6 weeks following completion of the study.
Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.
Inability to cooperate or communicate with the investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859131

Contacts

Contact: Tikvah Y Habib, BS

843-792-8824

habibt@musc.edu

Locations

United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Tikvah Habib 843-792-8824
Principal Investigator: Kenneth D. Chavin, MD, PhD

Sponsors and Collaborators

Medical University of South Carolina

Genzyme

Investigators

Principal Investigator:	Kenneth D Chavin, MD,PhD	Medical University of South Carolina
Study Chair:	Maria Francesca Egidi, MD	Medical University of South Carolina
Study Chair:	Nicole Weimert, PharmD	Medical University of South Carolina
Study Chair:	David Taber, PharmD	Medical University of South Carolina

More Information

No publications provided

Responsible Party:	Medical University of South Carolina ( Kenneth D. Chavin, MD, PhD )
Study ID Numbers:	thymo vs zen
Study First Received:	March 6, 2009
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00859131 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Antilymphocyte Serum
Renal Insufficiency
Immunologic Factors
Urologic Diseases
Renal Insufficiency, Chronic
Daclizumab

Mycophenolate mofetil
Kidney Failure, Chronic
Tacrolimus
Kidney Diseases
Immunosuppressive Agents
Kidney Failure

Additional relevant MeSH terms:

Antilymphocyte Serum
Renal Insufficiency
Immunologic Factors
Urologic Diseases
Renal Insufficiency, Chronic
Daclizumab

Physiological Effects of Drugs
Kidney Failure, Chronic
Kidney Diseases
Immunosuppressive Agents
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on May 06, 2009