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Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-Term Nephrotoxic Calcineurin Inhibitor Therapy


Phase 4
16 Years
N/A
Not Enrolling
Both
Living-Donor Kidney Transplant

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Trial Information

Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Living Donor Renal Transplantation - A Study to Evaluate the Avoidance of Long-Term Nephrotoxic Calcineurin Inhibitor Therapy


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 (36
months). Parent or legal guardian must provide written consent for patients <18
years of age.

2. Age 16-65 years

3. Weight > 40 kg

4. Primary renal allograft: living related (non HLA identical) and unrelated donor

5. Negative standard cross-match for T-cells. All 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 3 months
following discontinuation of Thymoglobulin or Campath-1H

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 virus (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 that 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, Campath-1H, Thymoglobulin,
Daclizumab (Zenapax®), Sirolimus, MMF 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 >200mg/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
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:

Interventional

Study Design:

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

Outcome Measure:

Incidence and severity of biopsy-proven acute rejection at 1 year.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

George W Burke

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami

Authority:

United States: Institutional Review Board

Study ID:

IRB#20010704

NCT ID:

NCT00681343

Start Date:

September 2002

Completion Date:

October 2007

Related Keywords:

  • Living-Donor Kidney Transplant
  • Randomized
  • study
  • effectiveness/toxicity
  • induction therapy
  • recipients

Name

Location

University of Miami Division of TransplantationMiami, Florida  33136