Thymoglobulin Versus Alemtuzumab Versus Daclizumab in Living Donor Renal Transplantation

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01046955

Enrollment

Registered

2010-01-12

Start date

2005-11-30

Completion date

2008-12-31

Last updated

2010-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Renal Disease, Living Donors

Keywords

ESRD

Brief 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.

Detailed 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.

Interventions

DRUGAnti-Thymocyte Globulin vs Campath-1H vs Daclizumab

comparison of induction therapies.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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
Patient/graft survival.	1 and 3 yrs.

Secondary

Measure	Time frame
Incidence of adverse reactions.	1 & 3 years.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026