Clinical trial • Not applicable • Immunology
TX200-TR101 for Kidney transplant rejection
Not applicable trial of TX200-TR101 for Kidney transplant rejection. open-label. 10 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Kidney transplant rejection
- Trial Stage
- Not applicable
- Drug Modality
- Cell therapy
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 08-07-2024
- First CTIS Authorization Date
- 31-07-2024
Trial design
open-label Not applicable trial across 4 sites in Belgium, Netherlands.
- Open Label
- Yes
- Target Sample Size
- 10
- Trial Duration For Participant
- 5475
Eligibility
Recruits 10 Vulnerable population selected. Consent handling: "Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study." No specific assent or parental consent procedures are provided in the available materials..
- Vulnerable Population
- Vulnerable population selected. Consent handling: "Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study." No specific assent or parental consent procedures are provided in the available materials.
Inclusion criteria
- {"criterion_text":"- 1. Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study."}
- {"criterion_text":"- 1. Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study."}
Exclusion criteria
- {"criterion_text":"- No Exclusion criteria for this study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Overall survival measured up to 15 years post-TX200-TR101 infusion/baseline per main objective."}
- {"endpoint_text":"- Indicence and grade of Serious Adverse Events","definition_or_measurement_approach":"Incidence and grading of Serious Adverse Events (SAEs); no further measurement detail provided."}
Secondary endpoints
- {"endpoint_text":"- Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing)","definition_or_measurement_approach":"Measured as incidence of BCAR episodes using Banff criteria (including type, severity and timing)."}
- {"endpoint_text":"- Incidence of graft loss due to rejection","definition_or_measurement_approach":"Measured as incidence of graft loss attributed to rejection; no further detail provided."}
- {"endpoint_text":"- Incidence and severity of chronic graft dysfunction, as measured by eGFR","definition_or_measurement_approach":"Measured by estimated glomerular filtration rate (eGFR) to assess incidence and severity of chronic graft dysfunction."}
Recruitment
- Planned Sample Size
- 10
- Recruitment Window Months
- 193
- Consent Approach
- Written informed consent is required from participants. Wording provided: "Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study." Subject information and ICF documents are available in English, Dutch and French per the listed publication documents. No specific assent or parental consent procedures are described in the available materials.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 20
Belgium
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 06-06-2025
- Processing Time Days
- 421
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- UZ Leuven
- Department Name
- Renal Transplantation
- Principal Investigator Name
- Dirk Kuypers
- Principal Investigator Email
- dirk.kuypers@uzleuven.be
- Contact Person Name
- Dirk Kuypers
- Contact Person Email
- dirk.kuypers@uzleuven.be
- Number Of Participants
- 10
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-04-2024
- Latest Decision Or Authorization Date
- 06-06-2025
- Processing Time Days
- 421
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Universiteit Leiden
- Department Name
- Division of Nephrology
- Contact Person Name
- Aiko De Vries
- Contact Person Email
- A.P.J.de_Vries@lumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Internal Medicine
- Contact Person Name
- Dennis Hesselink
- Contact Person Email
- d.a.hesselink@erasmusmc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Groningen Kidney Institute
- Contact Person Name
- Johannes Sanders
- Contact Person Email
- j.sanders@umcg.nl
Sponsor
Primary sponsor
- Full Name
- Sangamo Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Third parties
- {"country":"Ireland","full_name":"IDEA Innovative Drug European Associates (Ireland) Limited","duties_or_roles":"EU legal Rep","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Qualitymetric Incorporated LLC","duties_or_roles":"ePRO survey","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q-Square Business Intelligence Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- TX200-TR101
- Active Substance
- TX200-TR101
- Modality
- Cell therapy
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Orphan Designation
- Yes
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