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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01046955
Other study ID # 20010704
Secondary ID
Status Completed
Phase Phase 4
First received January 11, 2010
Last updated January 11, 2010
Start date November 2005
Est. completion date December 2008

Study information

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

Clinical Trial Summary

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.


Description:

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 (LD) kidneys, compared with our standard treatment protocol of Zenapax® and maintenance immunosuppression (vide infra).

To determine the effect different antibody induction regimen on the lymphoid cell subsets of the immune system in kidney allograft recipients peripheral blood and bone marrow aspirates will be tested at surgery before transplantation and at intervals post operatively.

To treat renal transplant patients successfully in the absence of long-term calcineurin inhibition to determine if there are beneficial effects on the prevention of chronic allograft nephropathy.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

Drug:
Anti-Thymocyte Globulin vs Campath-1H vs Daclizumab
comparison of induction therapies.

Locations

Country Name City State
United States University of Miami Jackson Memorial Hospital Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

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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