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

NCT01324934 | Terminated Phase 3 DMC

• 1 other identifier: AP-AS-24-ES
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 10

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.

Conditions

Renal Transplant Rejection

Keywords

acute rejection; chronic rejection; subclinical rejection; renal transplantation; steroid-free; kidney transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time of onset, histological severity and incidence of steroid resistance of acute and chronic rejections

  1 year

• Incidence and duration of initial DGF

  1 year

• Renal function

  1 year

• Patient and Graft survival

  1 year

• Safety endpoints are the incidence of AEs/SAEs and ADRs

  1 year

Study Arms (2)

Study Group

ACTIVE COMPARATOR

immunosuppressive treatment consisting of ATG-Fresenius/TAC/MMF or Myfortic

Drug: ATG-Fresenius S

Control Group

NO INTERVENTION

immunosuppressive treatment consisting of TAC, MMF or Myfortic, and corticosteroids.

Interventions

ATG-Fresenius S DRUG

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).

Study Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent form,
• End-stage renal disease,
• Candidates for a first transplantation,
• Re-transplant patients are eligible if a graft loss after transplantation was NOT due to immunological reasons,
• Availability of a heart-beating cadaveric donor up to 70 years of age with a cold ischemia time shorter than 36 hours,
• Male or female patients between 18 to 75 years of age inclusive,
• Patients able to comply with all study related requirements,
• Patients able to receive oral medication,
• Women of childbearing age with a safe contraceptive method throughout the study.

You may not qualify if:

• Women who are pregnant or breast feeding,
• Known Human Immunodeficiency Virus,
• Hepatitis B Virus or Hepatitis C Virus infection,
• Severe actual viral, bacterial or fungal infection not adequately controlled,
• Patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies or positive rabbit immunoglobulin skin test or known allergies to any component of the immunosuppressive drugs per protocol,
• Patients at high immunological risk defined as current PRA \> 25% or historical PRA \> 50%,
• Patients receiving pre-transplant immunosuppressive treatment, including corticosteroids,
• Patients with current or history of malignancies (exception basal cell carcinoma or squamous cell carcinoma in remission),
• Patients with previous transplantation except 1st graft loss due to surgical complications,
• Patients receiving combined transplantation,
• Patients with major organ dysfunctions,
• Serious psychiatric or psychological disorders,
• Pre-transplant thrombocytopenia: \< 50,000 thrombocytes/µl, Pre-transplant leukopenia: \< 2,000 leukocytes/µl,
• Unable or unwilling to comply fully with the protocol,
• Participation in another study of an investigational medicinal product concurrently or within the last 30 days.

Sponsors & Collaborators

• Neovii Biotech: lead
• Eurotrials Brasil Consultores Cientificos Ltda: collaborator
• Recerca Clínica S.L.: collaborator
• PsyConsult: collaborator

Study Sites (10)

Centro Hospitalar de Lisboa Ocidental

Carnaxide, 2799-523, Portugal

Location

Hospitais da Universidade de Coimbra

Coimbra, 3000-075, Portugal

Location

Hospital de Curry Cabral

Lisbon, 1069-166, Portugal

Location

Hospital Geral de Santo António, SA

Porto, 4090-001, Portugal

Location

Hospital Universitario Juan Canalejo

A Coruña, 15006, Spain

Location

Hospital Universitari Clinic i Provincial

Barcelona, 08036, Spain

Location

Hosptial Gregorio Maranon

Madrid, 28007, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Study Officials

• Manuel Rengel, Dr

  Hosptial Gregorio Maranon, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 29, 2011
• Study Start: October 1, 2006
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

PT (4); ES (6)