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Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols Accompanied by Maintenance Therapy With Prograf® and Myfortic®

Phase 4
15 Years
Not Enrolling
Transplant; Failure, Kidney

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Trial Information

Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols Accompanied by Maintenance Therapy With Prograf® and Myfortic®

Antibody Induction:

Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of
Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25
humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks
later. (controls) Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of
Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at
0.3 mg/kg within 24 hours. No further antibody therapy will be used.

In both groups, Prograf® maintenance therapy will be rapidly initiated (vide-infra) with a
targeting dosage to 12 hour trough levels of 4 to 8 ng/ml.

In Group I, maintenance dosing Myfortic® will be targeted to 720 mg twice daily. In Group
II, maintenance doses of Myfortic® will be targeted to 360 mg twice daily.

Steroids are to be given equivalently in both groups only during the first week
postoperatively. The regimen consists of 500 mg/day of Solumedrol intravenously for 3
postoperative days followed by daily oral methylprednisolone or IV Solumedrol at 1 mg/kg per
day, decreasing to 0.5 mg/kg per day during the remainder of the week primarily to avoid
hypersensitivity reactions to the induction antibodies. No further steroid use is planned.

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

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

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

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

Incidence of Acute Rejection at one year post-transplant

Outcome Time Frame:

at one year post-transplant

Safety Issue:



United States: Institutional Review Board

Study ID:

IRB #20057672



Start Date:

February 2006

Completion Date:

May 2010

Related Keywords:

  • Transplant; Failure, Kidney
  • adult
  • primary kidney transplant recipient
  • Renal Insufficiency



University Of Miami Miller School Of Medicine Miami, Florida  33010