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Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids

NCT01324934 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-05-01

No results posted yet for this study

Summary

The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year after renal transplantation.

Conditions

  • Renal Transplant Rejection

Interventions

DRUG

ATG-Fresenius S

Dosage: Single high-dose of 9 mg/kg pre-operatively, followed by 3 mg/kg/d at day +2 and +4. ATG-Fresenius treatment at Days 0, +2, and +4 is mandatory. (In case of persisting DGF, the treatment is left to the discretion of the investigator. Treatment options include the continuation of ATG-Fresenius treatment with 3 mg/kg/d at Day +6 and if deemed necessary also at Day +8 - but without corticosteroids).

Sponsors & Collaborators

  • Eurotrials Brasil Consultores Cientificos Ltda

    collaborator INDUSTRY

  • Recerca Clínica S.L.

    collaborator INDUSTRY

  • PsyConsult

    collaborator UNKNOWN

  • Neovii Biotech

    lead INDUSTRY

Principal Investigators

  • Manuel Rengel, Dr · Hosptial Gregorio Maranon, Madrid, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Portugal
  • Spain

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 NCT01324934 on ClinicalTrials.gov