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Comparison of ATG to Thymoglobuline in Renal Transplantation

NCT00861536 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-04-14

No results posted yet for this study

Summary

An open, multicenter, randomised, parallel group pilot study to investigate two different polyclonal rabbit immunoglobulin preparations for safety and efficacy: A comparison of ATG-Fresenius S to Thymoglobulin in prophylaxis for immunological high risk patients following renal transplantation. This non-inferiority trial shall demonstrate that ATG-Fresenius S is as efficacious as Thymoglobulin but has a better tolerance and fewer side effects.

Conditions

  • Transplantation, Kidney

Interventions

DRUG

ATG Fresenius

Day 0: 9 mg/kg bw bolus Days 1-4: 3 mg/kg bw/d

DRUG

Thymoglobuline Genzyme

Day 0-3: 1.5 mg/kg bw/d

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Juerg Steiger, MD,Prof · University Hospital Basel, Transplantation Immunology and Nephrology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861536 on ClinicalTrials.gov