Thymoglobulin Versus Campath-1H Versus Daclizumab in Adult, Primary Deceased Donor Renal Transplantation
Information source: University of Miami
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Transplantation
Intervention: Thymoglobulin (Drug); Campath-1H (Drug); Daclizumab (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Miami
Summary
To compare in a randomized prospective study the effectiveness and toxicity of Thymoglobulin
vs. Campath-1H used for induction therapy vs. our conventional therapy in recipients of
first cadaver (CAD) kidneys.
Clinical Details
Official title: Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Cadaver Donor Renal Transplantation: A Study to Evaluate the Avoidance of Long-Term Nephrotoxic Calcineurin Inhibitor Therapy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence and severity of biopsy-proven acute rejection at 1 year.
Secondary outcome: One-year and 3 year patient and graft survival.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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 (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 cadaver renal allograft
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 (HIV), or 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 and/or is taking or has
been taking 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, mycophenolate 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.
Locations and Contacts
University of Miami Division of Transplantation, Miami, Florida 33136, United States
Additional Information
Starting date: November 2002
Last updated: May 27, 2008
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