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

Renal Transplant Rejection Clinical Trial

— IBERICA  

Official title:

Prospective, Randomized, Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of Immunosuppression Following a Heart-beating Cadaveric Renal Transplantation Based on the Use of Rabbit Anti-T-lymphocyte Serum, Tacrolimus and Mycophenolate, Free of Concomitant Corticosteroids From the Start of Immunosuppression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01324934
• Other study ID #: AP-AS-24-ES
• Status: Terminated
• Phase: Phase 3
• First received: March 21, 2011
• Last updated: April 30, 2015
• Start date: October 2006
• Est. completion date: January 2011

Study information

• Verified date: April 2015
• Source: Neovii Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Ministry of Health and ConsumptionPortugal: Ethics Committee for Clinical ResearchPortugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplant Rejection

Intervention

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).

Locations

Country	Name	City	State
Portugal	Centro Hospitalar de Lisboa Ocidental	Carnaxide
Portugal	Hospitais da Universidade de Coimbra	Coimbra
Portugal	Hospital de Curry Cabral	Lisboa
Portugal	Hospital Geral de Santo António, SA	Porto
Spain	Hospital Universitario Juan Canalejo	A Coruña
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	Hosptial Gregorio Maranon	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Neovii Biotech	Eurotrials Brasil Consultores Cientificos Ltda, PsyConsult, Recerca Clínica S.L.

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time of onset, histological severity and incidence of steroid resistance of acute and chronic rejections		1 year	No
Secondary	Incidence and duration of initial DGF		1 year	No
Secondary	Renal function		1 year	No
Secondary	Patient and Graft survival		1 year	No
Secondary	Safety endpoints are the incidence of AEs/SAEs and ADRs		1 year	Yes