Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in Anew Kidney Transplant Patients
1 other identifier
interventional
280
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2012
Longer than P75 for phase_4
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2012
CompletedFirst Submitted
Initial submission to the registry
October 14, 2014
CompletedFirst Posted
Study publicly available on registry
October 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2015
CompletedNovember 1, 2024
October 1, 2024
3.4 years
October 14, 2014
October 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
efficacy failure
Efficacy failure is defined as any of the following events: * patient's death, * graft loss, * acute rejection, * and/or lost to follow-up.
12 months post-transplant
Secondary Outcomes (6)
Incidence of acute rejection
6 and 12 months
Incidence of DGF
6 and 12 months
Incidence of patient survival
6 and 12 months
Incidence of graft survival
6 and 12 months
Renal function: serum creatinine/eGFR
1, 3, 6 and 12 months
- +1 more secondary outcomes
Study Arms (2)
ATG-F single dosing group
EXPERIMENTALIntravenous (IV)
ATG-F continuous dosing group
EXPERIMENTALIntravenous (IV)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Beijing, China
Unknown Facility
Changchun, China
Unknown Facility
Chengdu, China
Unknown Facility
Guangzhou, China
Unknown Facility
Hangzhou, China
Unknown Facility
Jinan, China
Unknown Facility
Nanjing, China
Unknown Facility
Shanghai, China
Unknown Facility
Shenyang, China
Unknown Facility
Tianjin, China
Unknown Facility
Wenzhou, China
Unknown Facility
Wuhan, China
Unknown Facility
Xi'an, China
Unknown Facility
Zhengzhou, China
Related Links
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2014
First Posted
October 17, 2014
Study Start
July 31, 2012
Primary Completion
December 31, 2015
Study Completion
December 31, 2015
Last Updated
November 1, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.