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

Phase 3

Terminated

• Conditions: Renal Transplant Rejection
• Interventions: Drug: ATG-Fresenius S

• Registration Number: NCT01324934
• Lead Sponsor: Neovii Biotech

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	ATG-Fresenius S	immunosuppressive treatment consisting of ATG-Fresenius/TAC/MMF or Myfortic

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the incidence of biopsy-proven acute allograft rejection after 12 months, including all types of rejections like: • acute rejection • chronic rejection • subclinical rejection	1 year

Secondary Outcome Measures

Name	Time	Method
Incidence and duration of initial DGF	1 year
Time of onset, histological severity and incidence of steroid resistance of acute and chronic rejections	1 year
Renal function	1 year
Patient and Graft survival	1 year
Safety endpoints are the incidence of AEs/SAEs and ADRs	1 year

Trial Locations

Locations (10)

Hospitais da Universidade de Coimbra; 🇵🇹 Coimbra, Portugal

Hospital Geral de Santo António, SA; 🇵🇹 Porto, Portugal

Centro Hospitalar de Lisboa Ocidental; 🇵🇹 Carnaxide, Portugal

Hospital de Curry Cabral; 🇵🇹 Lisboa, Portugal

Hospital Universitario Juan Canalejo; 🇪🇸 A Coruña, Spain

Hosptial Gregorio Maranon; 🇪🇸 Madrid, Spain

Hospital Universitari Clinic i Provincial; 🇪🇸 Barcelona, Spain

Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain