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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01324934
Other study ID # AP-AS-24-ES
Secondary ID
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


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
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