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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506478-11-01 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypersensitive patients undergoing aHSCT | Experimental | hypersensitive patients undergoing aHSCT. All patients in this study participate in this arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hematopoietic precursor transplantation (TPHa) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the impact of autologous hematopoietic stem cell transplantation (aHSCT) | 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. | from enrolment to 12 months post-TPHa |
| 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 | 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
| from enrolment to 12 months post-aHSCT |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of HLA antibodies eliminated | Total number of HLA antibodies eliminated | from enrolment to 6 months post-aHSCT |
| Average number of HLA antibodies eliminated | Average number of HLA antibodies eliminated |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oriol Bestard, MD, PhD | Contact | 932746000 | 4661 | oriol.betsard@vallhebron.cat |
| Delphine Kervella, MD, PhD | Contact | 932746000 | 4661 | delphine.kervella@vallhebron.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
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|
| from enrolment to 6 months post-aHSCT |
| Mean reduction in MFI of immunodominant HLA antibody, class I and class II | Mean reduction in MFI of immunodominant HLA antibody, class I and class II | from enrolment to 6 months post-aHSCT |
| Proportion of patients transplanted with a compatible donor | Proportion of patients transplanted with a compatible donor | from enrolment to 12 months post-aHSCT |
| Adverse reactions related to aHSCT | Mesure the number of adverse reactions related to aHSCT | from enrolment to 12 months post-aHSCT |
| Incidence of opportunistic infections | Mesure the Incidence of opportunistic infections in treated patients | From aHSCT to 12 months after aHSCT or 12 months after kidney transplant (if it's occurs) |
| Incidence of clinical and/or subclinical rejection mediated by antibodies in the first year after kidney transplantation | Incidence of clinical and/or subclinical rejection mediated by antibodies in the first year after kidney transplantation | from kidney trasplantation to 12 months after |
| Proportion of patients free of DSA and/or donor-specific memory B cells at 1 year after kidney transplant | Proportion of patients free of DSA and/or donor-specific memory B cells at 1 year after kidney transplant | from kidney transplant to 1 year post kidney transplant |
| Changes in the clonal and phenotypic repertoire of B and T cells. | Changes in the clonal and phenotypic repertoire of B and T cells mesure with cytometry | From aHSCT to 12 months after aHSCT or 12 months after kidney transplant (if it's occurs) |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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