Phase
Condition
Kidney Disease
Focal Segmental Glomerulosclerosis
Treatment
hematopoietic precursor transplantation (TPHa)
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion 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 withdialysis.
Patient who is on the waiting list for kidney transplant from a death donor and whohas not received an offer for a compatible transplant in the last 3 years within thenational PATHI prioritization program.
cPRA calculated of more than 97% and having been in the program of prioritizationfor more than 3 years
Positive IgG serologies for Cytomegalovirus and Epstein Barr.
Women of childbearing potential must have a negative pregnancy test upon entry tothe study and must agree to use safe contraceptive methods according to theguideline CTFG recommendations on contraception in clinical trials during durationof the study (condoms are considered safe methods male and female, oralcontraceptives, etc.).
Patients vaccinated against tetanus, influenza, pneumococcus and herpes zoster
Exclusion
Exclusion Criteria:
Current known infection, recurrent bacteria, virus, fungus or fungus bacteria, orother infections (such as HIV, hepatitis B, hepatitis C, or zoster).
Concomitant serious uncontrolled major organ disease.
Any infection that requires hospitalization and intravenous treatment withantibiotics during the 4 weeks prior to screening, or oral treatment withantibiotics the previous 2 weeks.
Patients with primary or secondary immunodeficiencies.
Patient with an active history of tuberculosis (even if treated) or patients withuntreated latent tuberculosis.
Malignancy during the 5 years prior to screening, except for carcinoma of the basalcell 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) duringthe 4 weeks prior to screening.
Severe allergic or anaphylactic reactions to human monoclonal antibodies, humanizedor murine.
Treatment with any investigational agent during the 4 weeks (or 5 half-lives of theinvestigational drug, whichever is longer) prior to screening.
Immunization with live vaccine during the 2 months prior to screening.
Pregnant or breastfeeding women.
Study Design
Connect with a study center
Hospital Universitari Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.