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

RECRUITINGPHASE1/PHASE2

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

Phase 1b/2a Trial of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) From an HLA-partially Matched Related or Unrelated Donor After TCRαβ+ T-cell/CD19+ B-cell Depletion for Patients Who Will Receive a Kidney Transplant (KT) From the Same HSCT/KT Donor

NCT05508009•Alice Bertaina

View on ClinicalTrials.gov

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 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.

Eligibility

Age

1 - 30 years

Sex

ALL

Healthy Volunteers

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
•Serious concurrent uncontrolled medical disorders except for primary disease leading to chronic kidney disease
•Lack of patient/parent/guardian informed consent
+1 more criteria

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

Locations (1)

Lucile Packard Children's Hospital

Palo Alto, California, United States

Key Dates

Start Date

January 10, 2023

Primary Completion Date

October 1, 2032

Completion Date

October 1, 2034

Last Updated

July 17, 2023

Enrollment

ESTIMATED participants

Conditions

SIODCystinosisFSGSSLE NephritisCKD Stage 4

Interventions

Cyclophosphamide 1200 mg/Kg

DRUG

Fludarabine

DRUG

Cyclophosphamide 100 mg/Kg

DRUG

Total Body Irradiation

RADIATION

ATG

DRUG

Rituximab

DRUG

Melphalan

DRUG

CliniMACS® TCR α/β Reagent Kit and CliniMACS® CD19 System

DEVICE

Kidney Transplant

PROCEDURE

Use of Cysteamine in the Treatment of Cystinosis

NCT00359684

Cystinosis

View study

RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability and PK of SK-09

NCT07267026

FSGSMCD

View study

RECRUITING

European Cystinosis Cohort

NCT05901077

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Use of Cysteamine in the Treatment of Cystinosis

A Study to Evaluate the Safety, Tolerability and PK of SK-09

European Cystinosis Cohort

Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.

DFT383 in Pediatric Participants With Nephropathic Cystinosis

National Registry of Rare Kidney Diseases