Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Location status: Recruiting
NCT Number: NCT06809075
This is a study for hypersensitized patients who have been waiting for more than 3 years for an offer for a kidney transplant. The objective is to perform a transplant of autologous hematopoietic precursors with the aim of producing what we call an immunological reset to make the maximum number of anti-HLA antibodies disappear and thus increase the chances of the patient receiving an offer for a kidney transplant.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Barcelona, 08035, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An apheresis is performed on the patients and a selection of CD34 hematopoietic progenitors is performed. Subsequently, conditioning is performed with cyclophosphamide, thymoglobulin, corticosteroids and rituximab to subsequently infuse the hematopoietic precursors.
Time frame: from enrolment to 12 months post-TPHa
Variable composed with the proportion of patients in whom ≥10 HLA, class I or class II antibodies are eliminated (undetectable or <1000 MFI) or the percentage of baseline cPRA is decreased at 6 months after aHSCT, in the absence of severe undesirable effects related to the treatment.
Time frame: from enrolment to 12 months post-aHSCT
Proportion of patients achieving all of the following items at 6 months post-aHSCT or at the time of kidney transplant, if a compatible offer is received
Time frame: from enrolment to 6 months post-aHSCT
Total number of HLA antibodies eliminated
Time frame: from enrolment to 6 months post-aHSCT
Average number of HLA antibodies eliminated
Time frame: from enrolment to 6 months post-aHSCT
Mean reduction in MFI of immunodominant HLA antibody, class I and class II
Time frame: from enrolment to 12 months post-aHSCT
Proportion of patients transplanted with a compatible donor
Time frame: from enrolment to 12 months post-aHSCT
Mesure the number of adverse reactions related to aHSCT
Time frame: From aHSCT to 12 months after aHSCT or 12 months after kidney transplant (if it's occurs)
Mesure the Incidence of opportunistic infections in treated patients
Time frame: from kidney trasplantation to 12 months after
Incidence of clinical and/or subclinical rejection mediated by antibodies in the first year after kidney transplantation
Time frame: from kidney transplant to 1 year post kidney transplant
Proportion of patients free of DSA and/or donor-specific memory B cells at 1 year after kidney transplant
Time frame: From aHSCT to 12 months after aHSCT or 12 months after kidney transplant (if it's occurs)
Changes in the clonal and phenotypic repertoire of B and T cells mesure with cytometry
Contact information is provided by the study sponsor or research team.
Hospital Universitari Vall d'Hebron Research Institute
Other
Immunological Reset to Allow Access to HLA Compatible Transplantation in Highly Sensitized Kidney Transplant Candidates Through Non-myeloablative Autologous Stemm Cell Transplantation (RESET TRIAL)
Acronym: RESET
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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