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New treatment option for Kidney Disease
Official title Immunological Reset to Allow Access to HLA Compatible Transplantation in Highly Sensitized Kidney Transplant Candidates Through Non-myeloablative Autologous Stemm Cell Transplantation
ClinicalTrials.gov ID: NCT06809075
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- cPRA calculated of more than 97% and having been in the program of prioritization for more than 3 years
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- Patients vaccinated against tetanus, influenza, pneumococcus and herpes zoster
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.