Kidney Transplant RecipientsNCT02392312
Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients
An observational study of Kidney Transplant Recipients, run by Astellas Pharma China, Inc. at 25 sites in China.
Trial summary
A multicenter, prospective, observational study to evaluate the safety and efficacy of individual batches of ATG-F in kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Recipients
- What is being tested?
- ATF-Fresenius S
- Type of treatment
- Injection or infusion
- How many people
- 950 participants
- Where
- 25 sitesChina
- Study dates
- 21 Jan 2015to 16 Mar 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Governmental Hospital
Who may be able to join
- ATG-F administration to prophylaxis rejection in kidney transplantation recipient.
- 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
- Hypersensitivity to the active substance or to any of the excipients.).
- Subjects with bacterial, viral, mycotic or parasitic infections, which are not under adequate therapeutic control.
- Solid organ transplant subjects with severe thrombocytopenia, i.e. less than 50,000 platelets/µl because ATG-F may enhance thrombocytopenia and thus increase the risk of hemorrhage.
- Current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully.
- Subject is receiving a Human Leukocyte Antibody (HLA) identical living donor organ.
- Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Site: CN00004
Baotou
Site: CN00011
Beijing
Site: CN00012
Beijing
Site: CN00013
Beijing
Site: CN00016
Changchun
Site: CN00002
Chengdu
Site: CN00003
Chongqing
Site: CN00018
Fuzhou
Site: CN00023
Guangzhou
Site: CN00021
Haikou
Site: CN00022
Haikou
Site: CN00019
Hangzhou
Site: CN00020
Hangzhou
Site: CN00006
Jinan
Site: CN00017
Jinan
Site: CN00028
Kunming
Site: CN00030
Nanchang
Site: CN00015
Qingdao
Site: CN00010
Shiyan
Site: CN00014
Taiyuan
Site: CN00005
Tianjin
Site: CN00031
Ürümqi
Site: CN00001
Xi'an
Site: CN00033
Yantai
Site: CN00007
Zhengzhou
About this study
Official title: Safety and Efficacy of Individual Batches of ATG-F in Kidney Transplant Recipients: Multicentre, Prospective, Observational Study
A multicenter, prospective, observational study to evaluate the safety and efficacy of individual batches of ATG-F in kidney transplant recipients.
- Conditions
- Kidney Transplant Recipients
- Being tested
- ATF-Fresenius S
- Keywords
- kidney transplant, ATG-F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATF-Fresenius SDrug
intravenous
| Study group | Role | What they receive |
|---|---|---|
| ATF-Fresenius S | intravenous Receives: Drug: ATF-Fresenius S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse event
Measured: up to 3 months post-transplantation
Secondary outcomes (4)
Clinical diagnosis of acute rejection
Measured: up to 3 months post-transplantation
Renal function: serum creatinine
Measured: at month 1 and month 3
Incidence of delayed graft function (DGF)
Measured: up to 3 months post-transplantation
Patient and graft survival
Measured: up to 3 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study start21 Jan 2015
- Primary completion16 Mar 2018
- Study completion16 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RecipientsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma China, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392312
- Sponsor's protocol ID
- ATG-MA-ACN001
- Status last verified
- Jan 2019
- First submitted
- 13 Mar 2015
- Last updated
- 21 Oct 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 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Individual Batches of ATG-F in Kidney Transplant Recipients: Multicentre, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT02392312
- Acronym / sponsor ID
- ATG-MA-ACN001
- Conditions
- Kidney Transplant Recipients
- Keywords
- kidney transplant, ATG-F
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 950 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 16 Mar 2018 (actual)
- Study completion
- 16 Mar 2018 (actual)
- First posted
- 18 Mar 2015 (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.
A multicenter, prospective, observational study to evaluate the safety and efficacy of individual batches of ATG-F in kidney transplant recipients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATF-Fresenius S | – | Drug: ATF-Fresenius Sintravenous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Governmental Hospital
Key inclusion criteria (2 listed)
- ATG-F administration to prophylaxis rejection in kidney transplantation recipient.
- 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 (6 listed)
- Hypersensitivity to the active substance or to any of the excipients.).
- Subjects with bacterial, viral, mycotic or parasitic infections, which are not under adequate therapeutic control.
- Solid organ transplant subjects with severe thrombocytopenia, i.e. less than 50,000 platelets/µl because ATG-F may enhance thrombocytopenia and thus increase the risk of hemorrhage.
- Current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully.
- Subject is receiving a Human Leukocyte Antibody (HLA) identical living donor organ.
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 |
|---|---|---|
| ATF-Fresenius Sintravenous | Drug | ATF-Fresenius S |
Primary outcome
Incidence and severity of adverse event
Time frame: up to 3 months post-transplantation
4 secondary outcomes
Clinical diagnosis of acute rejection
Time frame: up to 3 months post-transplantation
Renal function: serum creatinine
Time frame: at month 1 and month 3
Incidence of delayed graft function (DGF)
Time frame: up to 3 months post-transplantation
Patient and graft survival
Time frame: up to 3 months post-transplantation
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 21 Oct 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/.
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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 China, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Recipients, run by Astellas Pharma China, Inc. at 25 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 2 inclusion and 6 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 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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.
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?
Incidence and severity of adverse event (time frame: up to 3 months post-transplantation). 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 21 Oct 2024.