Overview

Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the present study is to determine which antibody induction regimen will result in a safer and more effective method to use with steroid avoidance in renal transplant recipients. Patients receiving either first cadaveric or non-HLA identical living donor kidney transplants will be preoperatively randomized into 2 groups.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Miami
Treatments:
Alemtuzumab
Antibodies
Antilymphocyte Serum
Daclizumab
Immunoglobulin G
Immunoglobulins
Thymoglobulin
Criteria
Inclusion Criteria:

1. Patient has been fully informed and has signed a dated IRB approval informed consent
form and is willing to follow study procedures for the extent of the study (12
months). Parent or legal guardian must provide written consent for patients <18 years
of age.

2. Age 18-70 years

3. Weight > 40 kg

4. Primary renal allograft: living or deceased donor

5. Negative standard crossmatch for T cells. All deceased donor-recipient pairs matched
for a minimum of 1 HLA DR antigen. (Standard at our center.)

6. Women of childbearing potential will be required to have a negative qualitative serum
pregnancy test and agree to use an adequate method of contraception for the study
duration.

7. Males and females are to be studied equivalently as they become available for
transplantation using these criteria.

-

Exclusion Criteria:

- 1. Patient has previously received or is receiving an organ transplant other than a
kidney.

2. Patient is receiving an ABO incompatible donor kidney. 3. Recipient or donor is
seropositive for human immunodeficiency (HIV), Hepatitis C viruses, or Hepatitis B
virus antigenemia.

4. Patient has a current malignancy or a history of malignancy (within the past 5
years), except non-metastatic basal or squamous cell carcinoma of the skin that has
been treated successfully, or carcinoma in situ of the cervix that has been treated
successfully.

5. Patients with significant liver disease, defined as having during the past 28 days
continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the
upper value of the normal range of this center.

6. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting,
active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any
other unstable medical condition that could interfere with study objectives.

7. Patient is currently participating in another clinical trial of an investigational
drug in the 30 days prior to transplant.

8. Patient will be receiving any immunosuppressive agent other than those prescribed
in the study.

9. Patient is unable to take medications orally or via nasogastric tube by the morning
of the second day following completion of the transplant procedure (i.e., skin
closure).

10. Patient is receiving or may require warfarin, fluvastatin, or herbal supplements
during the study.

11. Concurrent use of astemizole, pimozide, cisapride, terfenadine, or ketoconazole.

12. Patient has a known hypersensitivity to tacrolimus, Thymoglobulin®, IL-2 receptor
inhibitor monoclonal antibodies, alemtuzumab, sirolimus, MMF, Myfortic®, or
corticosteroids.

13. Patient is pregnant or lactating. 14. Patients with a screening/baseline (or
within 96 hours of transplant) total white blood cell count <4000/mm3; platelet count
<100,000/mm3; fasting triglycerides >400 mg/dl (>4.6 mmol/L); fasting total
cholesterol >300 mg/dl (>7.8 mmol/L); fasting HDL-cholesterol <30 mg/dl; fasting
LDL-cholesterol >200 mg/dl.

15. Patient is unlikely to comply with the visits scheduled in the protocol. 16.
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.

17. If tacrolimus cannot be instituted for longer than 5 days postoperatively.