Clinical trial NCT01324934: Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Renal Transplant Rejection
Keywords: acute rejection
chronic rejection
subclinical rejection
renal transplantation
steroid-free
kidney transplantation
Lead sponsor: Neovii Biotech
Sponsor class: INDUSTRY
Collaborators: name: Eurotrials Brasil Consultores Cientificos Ltda
name: Recerca Clínica S.L.
name: PsyConsult
First posted: 2011-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: Time of onset, histological severity and incidence of steroid resistance of acute and chronic rejections
timeFrame: 1 year
measure: Incidence and duration of initial DGF
timeFrame: 1 year
measure: Renal function
timeFrame: 1 year
measure: Patient and Graft survival
timeFrame: 1 year
measure: Safety endpoints are the incidence of AEs/SAEs and ADRs
timeFrame: 1 year
Other outcomes:
Locations:
city: Carnaxide
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra
city: Lisboa
country: Portugal
facility: Hospital de Curry Cabral
city: Porto
country: Portugal
facility: Hospital Geral de Santo António, SA
city: A Coruña
country: Spain
facility: Hospital Universitario Juan Canalejo
city: Barcelona
country: Spain
facility: Hospital Universitari Clinic i Provincial
city: Madrid
country: Spain
facility: Hosptial Gregorio Maranon
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hosptial Gregorio Maranon, Madrid, Spain
name: Manuel Rengel, Dr
role: PRINCIPAL_INVESTIGATOR
References: