Clinical trial NCT02267512: Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in Anew Kidney Transplant Patients
Official title: Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in de Novo Kidney Transplant Patients - a Multicenter, Randomized, Parallel Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: De Novo Kidney Transplant Patients
Keywords: Kidney Transplant Patients
ATG-F
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-10-17
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in anew kidney transplant recipients.

Detailed description: To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in de novo kidney transplant recipients. The primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate.

The secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed graft function) and renal function

Eligibility criteria: Inclusion Criteria:

* Patient with end stage kidney disease who is a suitable candidate for primary kidney transplantation.
* Patients scheduled to undergo renal allograft transplantation with compatible ABO blood type.
* Peak PRA \<50%
* Females of childbearing potential must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study.
* Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.

Exclusion Criteria:

* Subject has previously received or is receiving an organ transplant other than kidney
* Subject is receiving double-kidney transplant.
* Subject is receiving an ABO incompatible or T-cells cross match positive transplant.
* Cold ischemia time of allograft is \> 24 hours before kidney transplantation surgery.
* Subject is receiving organ from a Human Leukocyte Antibody (HLA) identical donor.
* Known contraindication to administration of ATG-F, including:

  * Subject has known hypersensitivity to rabbit proteins
  * Subject with severe thrombocytopenia
  * Subject with bacterial, viral or mycotic infections which are not under therapeutically control
* Subject has known hypersensitivity to tacrolimus, macrolide antibiotics, mycophenolate mofetil, or any of the product excipients.
* Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of the investigator or has a history of non-compliance.
* Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception during the study and for 6 weeks following completion of the study.
* Patients with evidence of active liver disease (liver function tests ≥ 2 times upper limit of normal) or the presence of a chronic active hepatitis B or C.
* Recipient or donor is seropositive for human immunodeficiency virus (HIV).

Primary outcomes:
measure: efficacy failure
timeFrame: 12 months post-transplant
Secondary outcomes:
measure: Incidence of acute rejection
timeFrame: 6 and 12 months
measure: Incidence of DGF
timeFrame: 6 and 12 months
measure: Incidence of patient survival
timeFrame: 6 and 12 months
measure: Incidence of graft survival
timeFrame: 6 and 12 months
measure: Renal function: serum creatinine/eGFR
timeFrame: 1, 3, 6 and 12 months
measure: incidence and severity of AEs
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
city: Changchun
country: China
city: Chengdu
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Jinan
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Tianjin
country: China
city: Wenzhou
country: China
city: Wuhan
country: China
city: Xi'an
country: China
city: Zhengzhou
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: