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

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

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.

Study Overview

• Status: Completed
• Conditions: De Novo Kidney Transplant Patients
• Intervention / Treatment: Drug: ATG-F

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 Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Changchun, China
  • Chengdu, China
  • Guangzhou, China
  • Hangzhou, China
  • Jinan, China
  • Nanjing, China
  • Shanghai, China
  • Shenyang, China
  • Tianjin, China
  • Wenzhou, China
  • Wuhan, China
  • Xi'an, China
  • Zhengzhou, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute rejection		6 and 12 months
Incidence of DGF	DGF = delayed graft function	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
incidence and severity of AEs		6 months and 12 months

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2012
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Kidney Transplant Patients; ATG-F
• Other Study ID Numbers: ACN-ATG-KTx-12-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."