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New treatment option for SIOD
Official title Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor
ClinicalTrials.gov ID: NCT05508009
What this study is testing
What is Cyclophosphamide 1200 mg/Kg?
Cyclophosphamide 1200 mg/Kg is an investigational medicine, being studied as a potential treatment for siod.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 the absence of any post-KT immunosuppression, to abrogate the need for lifelong immunosuppression, the risk of chronic rejection and, ultimately, the need for repeated transplantation.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 30
You may be able to join if
- Anticipated need for kidney transplant due to: a. Underlying genetic/immunologic disease the following conditions i. SIOD ii. FSGS iii. Cystinosis...
- 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...
- Lansky/Karnofsky score \> 50; the Karnofsky Scale will be used in people ≥ 16 years of age, and the Lansky Scale will be used for those \< 16 years...
You likely can't join if
- 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...
- Severe cardiovascular disease at the time of evaluation unresponsive to nutritional and dialytic support (left ventricular ejection fraction \< 40%)...
- Current active infectious disease. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral...
- Serious concurrent uncontrolled medical disorders except for primary disease leading to chronic kidney disease
See the full eligibility 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...
- 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 people ≥ 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 people 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
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, 1 year to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. 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.