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Rabbit Anti-thymocyte Globulin Versus IL2 Receptor Antagonists in Combination With Tacrolimus, Corticosteroids and Mycophenolate Mofetil in a Predominantly High Risk Kidney Transplant Population.


N/A
18 Years
75 Years
Open (Enrolling)
Both
End Stage Renal Disease

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Trial Information

Rabbit Anti-thymocyte Globulin Versus IL2 Receptor Antagonists in Combination With Tacrolimus, Corticosteroids and Mycophenolate Mofetil in a Predominantly High Risk Kidney Transplant Population.


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.


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.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

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.

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Kenneth D Chavin, MD,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Medical University of South Carolina

Authority:

United States: Institutional Review Board

Study ID:

thymo vs IL2

NCT ID:

NCT00859131

Start Date:

March 2009

Completion Date:

August 2013

Related Keywords:

  • End Stage Renal Disease
  • Kidney Diseases
  • Kidney Failure, Chronic

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721