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

Sponsor

Neovii Biotech (Industry)

Overall Status

Terminated

CT.gov ID

NCT01324934

Collaborator

Eurotrials Brasil Consultores Cientificos Ltda (Industry), Recerca Clínica S.L. (Industry), PsyConsult (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplant Rejection	Drug: ATG-Fresenius S	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Study Group immunosuppressive treatment consisting of ATG-Fresenius/TAC/MMF or Myfortic	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).
No Intervention: Control Group immunosuppressive treatment consisting of TAC, MMF or Myfortic, and corticosteroids.

Arm

Intervention/Treatment

Active Comparator: Study Group

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

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).

No Intervention: Control Group

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centro Hospitalar de Lisboa Ocidental	Carnaxide	Portugal	2799-523
2	Hospitais da Universidade de Coimbra	Coimbra	Portugal	3000-075
3	Hospital de Curry Cabral	Lisboa	Portugal	1069-166
4	Hospital Geral de Santo António, SA	Porto	Portugal	4090-001
5	Hospital Universitario Juan Canalejo	A Coruña	Spain	15006
6	Hospital Universitari Clinic i Provincial	Barcelona	Spain	08036
7	Hosptial Gregorio Maranon	Madrid	Spain	28007
8	Fundación Jiménez Díaz	Madrid	Spain	28040
9	Hospital Universitario 12 de Octubre	Madrid	Spain	28041
10	Hospital Universitario La Paz	Madrid	Spain	28046