End-Stage Renal Disease Clinical Trial
Official title:
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
Verified date | May 2008 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to observe in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor (LD) kidneys, compared with the investigators standard treatment protocol of Zenapax® and maintenance immunosuppression.
Status | Completed |
Enrollment | 38 |
Est. completion date | December 2008 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years and older |
Eligibility |
Inclusion Criteria: - Age >14 years - Weight >40 kg - Primary renal allograft:living related (non HLA identical) and unrelated donor - Negative standard cross match for T-cells - Signed and dated consent form Exclusion Criteria: - Patient has previously received or is receiving an organ transplant other than kidney - Patient has received a kidney transplant from a non-heart beating donor - Patient has received an ABO incompatible donor kidney - Recipient or donor is seropositive for human immunodeficiency virus (HIV) - Patient has a current malignancy or a history of malignancy |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Jackson Memorial Hospital | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | Hoffmann-La Roche |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To observe in a randomized prospective pilot study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy in recipients of living donor kidneys. | 3 years | No | |
Primary | Patient/graft survival. | 1 and 3 yrs. | No | |
Secondary | Incidence of adverse reactions. | 1 & 3 years. | No |
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