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Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in Anew Kidney Transplant Patients

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT02267512
Collaborator
(none)
280
Enrollment
14
Locations
2
Arms
41
Actual Duration (Months)
20
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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

Study Design

Study Type:
Interventional
Actual Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jul 31, 2012
Actual Primary Completion Date :
Dec 31, 2015
Actual Study Completion Date :
Dec 31, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: ATG-F single dosing group

Intravenous (IV)

Drug: ATG-F
Intravenous (IV)
Experimental: ATG-F continuous dosing group

Intravenous (IV)

Drug: ATG-F
Intravenous (IV)

Outcome Measures

Primary Outcome Measures

  1. efficacy failure [12 months post-transplant]

    Efficacy failure is defined as any of the following events: patient's death, graft loss, acute rejection, and/or lost to follow-up.

Secondary Outcome Measures

  1. Incidence of acute rejection [6 and 12 months]

  2. Incidence of DGF [6 and 12 months]

    DGF = delayed graft function

  3. Incidence of patient survival [6 and 12 months]

  4. Incidence of graft survival [6 and 12 months]

  5. Renal function: serum creatinine/eGFR [1, 3, 6 and 12 months]

  6. incidence and severity of AEs [6 months and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing China
2 Changchun China
3 Chengdu China
4 Guangzhou China
5 Hangzhou China
6 Jinan China
7 Nanjing China
8 Shanghai China
9 Shenyang China
10 Tianjin China
11 Wenzhou China
12 Wuhan China
13 Xi'an China
14 Zhengzhou China

Sponsors and Collaborators

  • Astellas Pharma Inc

Investigators

  • Study Director: Medical Director, Astellas Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT02267512
Other Study ID Numbers:
  • ACN-ATG-KTx-12-1
First Posted:
Oct 17, 2014
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Astellas Pharma Inc
Kidney Transplant Patients
ATG-F

Study Results

No Results Posted as of Jul 27, 2022