De Novo Kidney Transplant PatientsPhase 4NCT02267512
Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in Anew Kidney Transplant Patients
A Phase 4 study testing ATG-F in people with De Novo Kidney Transplant Patients, run by Astellas Pharma Inc at 14 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- De Novo Kidney Transplant Patients
- What is being tested?
- ATG-F
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 14 sitesChina
- Study dates
- 31 Jul 2012to 31 Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 14Show fewer
- 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).
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Study site
Beijing
Study site
Changchun
Study site
Chengdu
Study site
Guangzhou
Study site
Hangzhou
Study site
Jinan
Study site
Nanjing
Study site
Shanghai
Study site
Shenyang
Study site
Tianjin
Study site
Wenzhou
Study site
Wuhan
Study site
Xi'an
Study site
Zhengzhou
About this study
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
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.
Read the 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
- Conditions
- De Novo Kidney Transplant Patients
- Being tested
- ATG-F
- Keywords
- Kidney Transplant Patients, ATG-F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-FDrug
Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| ATG-F single dosing group | Experimental | Intravenous (IV) Receives: Drug: ATG-F |
| ATG-F continuous dosing group | Experimental | Intravenous (IV) Receives: Drug: ATG-F |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-transplant
Secondary outcomes (6)
Incidence of acute rejection
Measured: 6 and 12 months
Incidence of DGF
DGF = delayed graft function
Measured: 6 and 12 months
Incidence of patient survival
Measured: 6 and 12 months
Incidence of graft survival
Measured: 6 and 12 months
Renal function: serum creatinine/eGFR
Measured: 1, 3, 6 and 12 months
incidence and severity of AEs
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start31 Jul 2012
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De Novo Kidney Transplant PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267512
- Sponsor's protocol ID
- ACN-ATG-KTx-12-1
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2014
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02267512
- Acronym / sponsor ID
- ACN-ATG-KTx-12-1
- Conditions
- De Novo Kidney Transplant Patients
- Keywords
- Kidney Transplant Patients, ATG-F
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2012 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATG-F single dosing group | Experimental | Drug: ATG-FIntravenous (IV) |
| ATG-F continuous dosing group | Experimental | Drug: ATG-FIntravenous (IV) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG-FIntravenous (IV) | Drug | ATG-F continuous dosing group, ATG-F single dosing group |
Primary outcome
efficacy failure
Time frame: 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.
6 secondary outcomes
Incidence of acute rejection
Time frame: 6 and 12 months
Incidence of DGF
Time frame: 6 and 12 months
Incidence of patient survival
Time frame: 6 and 12 months
Incidence of graft survival
Time frame: 6 and 12 months
Renal function: serum creatinine/eGFR
Time frame: 1, 3, 6 and 12 months
incidence and severity of AEs
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: No. 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/.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Inc
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ATG-F in people with De Novo Kidney Transplant Patients, run by Astellas Pharma Inc at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy failure (time frame: 12 months post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.