Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046955
• Other study ID #: 20010704
• 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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic
• Living Donors

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