Kidney DiseaseRESETNCT06809075
Immunological Reset to Allow Access to HLA Compatible Transplantation in Highly Sensitized Kidney Transplant Candidates Through Non-myeloablative Autologous Stemm Cell Transplantation
A study testing hematopoietic precursor transplantation (TPHa) in people with Kidney Disease and Kidney Transplant, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Disease, Kidney Transplant, Kidney Transplant Candidates
- What is being tested?
- hematopoietic precursor transplantation (TPHa)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 5 Apr 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The patient must be able to understand and give written consent.
- Women and men between 18 and 65 years old.
- Patients with chronic kidney disease who are on renal therapy replacement with dialysis.
- Patient who is on the waiting list for kidney transplant from a death donor and who has not received an offer for a compatible transplant in the last 3 years within the national PATHI prioritization program.
- cPRA calculated of more than 97% and having been in the program of prioritization for more than 3 years
- Positive IgG serologies for Cytomegalovirus and Epstein Barr.
- Women of childbearing potential must have a negative pregnancy test upon entry to the study and must agree to use safe contraceptive methods according to the guideline CTFG recommendations on contraception in clinical trials during duration of the study (condoms are considered safe methods male and female, oral contraceptives, etc.).
- Patients vaccinated against tetanus, influenza, pneumococcus and herpes zoster
Who cannot join
- Current known infection, recurrent bacteria, virus, fungus or fungus bacteria, or other infections (such as HIV, hepatitis B, hepatitis C, or zoster).
- Concomitant serious uncontrolled major organ disease.
- Any infection that requires hospitalization and intravenous treatment with antibiotics during the 4 weeks prior to screening, or oral treatment with antibiotics the previous 2 weeks.
- Patients with primary or secondary immunodeficiencies.
- Patient with an active history of tuberculosis (even if treated) or patients with untreated latent tuberculosis.
- Malignancy during the 5 years prior to screening, except for carcinoma of the basal cell or squamous cell carcinoma properly removed.
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- Known abuse of alcohol, drugs or chemicals within 1 year prior to screening.
- Patients with complicated peripheral venous access
- Neutropenia (ANC <1000/uL) or thrombocytopenia (platelet count <100,000/uL) during the 4 weeks prior to screening.
- Severe allergic or anaphylactic reactions to human monoclonal antibodies, humanized or murine.
- Treatment with any investigational agent during the 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening.
- Immunization with live vaccine during the 2 months prior to screening.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Oriol Bestard, MD, PhD, 932746000, oriol.bestard@vallhebron.cat
About this study
Official title: Immunological Reset to Allow Access to HLA Compatible Transplantation in Highly Sensitized Kidney Transplant Candidates Through Non-myeloablative Autologous Stemm Cell Transplantation (RESET TRIAL)
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.
- Being tested
- hematopoietic precursor transplantation (TPHa)
- Keywords
- HLA, TPHa, Kidney transplant, hypersensitized patient, cPRA, immunosuppression, DSA, aHSCT
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hematopoietic precursor transplantation (TPHa)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| hypersensitive patients undergoing aHSCT | Experimental | hypersensitive patients undergoing aHSCT. All patients in this study participate in this arm. Receives: Procedure: hematopoietic precursor transplantation (TPHa) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- Elimination/reduction of HLA antibody-secreting plasma cells in the bone marrow
- Absence/reduction of HLA-specific memory B cells in circulation
Measured: from enrolment to 12 months post-aHSCT
Secondary outcomes (9)
Total number of HLA antibodies eliminated
Total number of HLA antibodies eliminated
Measured: from enrolment to 6 months post-aHSCT
Average number of HLA antibodies eliminated
Average number of HLA antibodies eliminated
Measured: 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
Measured: from enrolment to 6 months post-aHSCT
Proportion of patients transplanted with a compatible donor
Proportion of patients transplanted with a compatible donor
Measured: from enrolment to 12 months post-aHSCT
Adverse reactions related to aHSCT
Mesure the number of adverse reactions related to aHSCT
Measured: from enrolment to 12 months post-aHSCT
Incidence of opportunistic infections
Mesure the Incidence of opportunistic infections in treated patients
Measured: 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
Measured: 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
Measured: 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
Measured: From aHSCT to 12 months after aHSCT or 12 months after kidney transplant (if it's occurs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start5 Apr 2024
- Primary completion1 Dec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809075
- Sponsor's protocol ID
- RESET
- Other IDs
- 2023-506478-11-01, 2023
- Acronym
- RESET
- Status last verified
- Feb 2025
- First submitted
- 3 Oct 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Reset to Allow Access to HLA Compatible Transplantation in Highly Sensitized Kidney Transplant Candidates Through Non-myeloablative Autologous Stemm Cell Transplantation (RESET TRIAL)
- ClinicalTrials.gov ID
- NCT06809075
- Acronym / sponsor ID
- RESET / RESET
- Keywords
- HLA, TPHa, Kidney transplant, hypersensitized patient, cPRA, immunosuppression, DSA, aHSCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Feb 2025 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypersensitive patients undergoing aHSCT | Experimental | Procedure: hematopoietic precursor transplantation (TPHa)hypersensitive patients undergoing aHSCT. All patients in this study participate in this arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient must be able to understand and give written consent.
- Women and men between 18 and 65 years old.
- Patients with chronic kidney disease who are on renal therapy replacement with dialysis.
- Patient who is on the waiting list for kidney transplant from a death donor and who has not received an offer for a compatible transplant in the last 3 years within the national PATHI prioritization program.
- cPRA calculated of more than 97% and having been in the program of prioritization for more than 3 years
Key exclusion criteria (13 listed)
- Current known infection, recurrent bacteria, virus, fungus or fungus bacteria, or other infections (such as HIV, hepatitis B, hepatitis C, or zoster).
- Concomitant serious uncontrolled major organ disease.
- Any infection that requires hospitalization and intravenous treatment with antibiotics during the 4 weeks prior to screening, or oral treatment with antibiotics the previous 2 weeks.
- Patients with primary or secondary immunodeficiencies.
- Patient with an active history of tuberculosis (even if treated) or patients with untreated latent tuberculosis.
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 |
|---|---|---|
| hematopoietic precursor transplantation (TPHa)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. | Procedure or surgery | hypersensitive patients undergoing aHSCT |
Primary outcome
To evaluate the impact of autologous hematopoietic stem cell transplantation (aHSCT)
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.
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 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 * Elimination/reduction of HLA antibody-secreting plasma cells in the bone marrow * Absence/reduction of HLA-specific memory B cells in circulation
9 secondary outcomes
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 6 months post-aHSCT
Proportion of patients transplanted with a compatible donor
Time frame: from enrolment to 12 months post-aHSCT
Adverse reactions related to aHSCT
Time frame: from enrolment to 12 months post-aHSCT
Incidence of opportunistic infections
Time frame: 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
Time frame: 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
Time frame: from kidney transplant to 1 year post kidney transplant
Changes in the clonal and phenotypic repertoire of B and T cells.
Time frame: From aHSCT to 12 months after aHSCT or 12 months after kidney transplant (if it's occurs)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hematopoietic precursor transplantation (TPHa) in people with Kidney Disease and Kidney Transplant, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oriol Bestard, MD, PhD (932746000 ext. 4661, oriol.betsard@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the impact of autologous hematopoietic stem cell transplantation (aHSCT) (time frame: from enrolment to 12 months post-TPHa). The study lists 2 primary outcomes in all. 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 12 Feb 2025.