Status:
RECRUITING
Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor
Lead Sponsor:
Alice Bertaina
Collaborating Sponsors:
California Institute for Regenerative Medicine (CIRM)
Conditions:
SIOD
Cystinosis
Eligibility:
All Genders
1-30 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single center, non-randomized, non-controlled open-label phase 1b/2a trial of performing sequential αβdepleted-HSCT and KT in patients requiring KT to prevent kidney rejection post-KT, in th...
Eligibility Criteria
Inclusion Criteria:
-
Anticipated need for kidney transplant due to:
a. Underlying genetic/immunologic disease the following conditions i. SIOD ii. FSGS iii. Cystinosis iv. SLE v. Membranoproliferative glomerulonephritis vi. Renal vasculitis characterized by positivity of the presence of ANCA vii. Other genetic diseases leading to kidney disease requiring KT Or b. Patients who have rejected a previous KT regardless of the underlying disease
-
Chronic kidney disease (CKD) stage 3 or greater
-
Steroids < 0.5 mg/Kg/day
-
The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DQB1 and HLA-DRB1
-
Lansky/Karnofsky score > 50; the Karnofsky Scale will be used in subjects ≥ 16 years of age, and the Lansky Scale will be used for those < 16 years of age.
-
Able to give informed consent or have an LAR available to provide consent
-
Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any cGvHD
Exclusion Criteria:
- Pregnant or lactating females.
- Greater than Grade II aGvHD or severe, unmanaged extensive cGvHD due to a previous allograft at the time of inclusion
- Dysfunction of liver (ALT/AST > 10 times upper normal value, or direct bilirubin > 3 times upper normal value), unmanageable dysfunction of renal function while undergoing dialysis
- Severe cardiovascular disease at the time of evaluation unresponsive to nutritional and dialytic support (left ventricular ejection fraction < 40%), or clinical or echocardiographic evidence of severe diastolic dysfunction
- Current active infectious disease. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment are eligible if they have an undetectable HCV viral load.
- Serious concurrent uncontrolled medical disorders except for primary disease leading to chronic kidney disease
- Lack of patient/parent/guardian informed consent
- Any severe concurrent disease which, in the judgement of the investigator would place the patient at increased risk during participation in the study
Key Trial Info
Start Date :
January 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2034
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05508009
Start Date
January 10 2023
End Date
October 1 2034
Last Update
July 17 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94305