Back to search results

Early Trial of Stem Cell and Kidney Transplant for Kidney Disease

This study is exploring a new approach for children and young adults (ages 1-30) who need a kidney transplant due to conditions like SIOD, Cystinosis, FSGS, SLE Nephritis, or CKD Stage 4. The goal is to see if giving a stem cell transplant (using drugs like Cyclophosphamide, Fludarabine, and ATG, plus Total Body Irradiation) from the same donor before a kidney transplant can help you avoid needing lifelong anti-rejection medicines. Researchers want to see how many patients can stop taking these medicines 90 days after their kidney transplant. This is an early-stage study with a planned enrollment of 12 participants, and its current status is unclear.

Study design
This is an early-stage (Phase 1b/2a), open-label study without a comparison group, involving 12 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured 90 days after the kidney transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05508009

Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor

Recruiting
PHASE1Ages 1–30InterventionalTreatment
Alice Bertaina
~12 participants
Updated 2023-07-17 on ClinicalTrials.gov
What's tested:Cyclophosphamide 1200 mg/KgFludarabineCyclophosphamide 100 mg/KgTotal Body IrradiationATGRituximab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients who are able to discontinue immunosuppression post-KT
Measured over Day +90 post-KT

Conditions

SIOD
Cystinosis
FSGS
SLE Nephritis
CKD Stage 4

Explore related trials

Chronic Kidney DiseaseCystinosisFocal Segmental GlomerulosclerosisMembranoproliferative GlomerulonephritisRenal vasculitisSchimke Immunoosseous DysplasiaSystemic Lupus ErythematosusFanconi Anemia Group A ProteinHLA Complex

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Alice Bertaina, MD · PRINCIPAL_INVESTIGATOR · Stanford University
  • Paul Grimm, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

SCGT Clinical Trials Program
[email protected]
650-723-0912
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Anticipated need for kidney transplant due to:
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

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

What this trial measures

  • Number of patients who are able to discontinue immunosuppression post-KTDay +90 post-KT

    Donor chimerism equal or greater to 95% after successful HSCT/KT therapy allows for withdrawal of immunosuppressive therapy in patient