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NCT05508009 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Cystinosis and FSGS, sponsored by Alice Bertaina.

Recruiting
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT05508009 is a Phase 1 study of Cystinosis and FSGS that is actively recruiting participants, run by Alice Bertaina. The registered enrollment target is 12 participants, below the 202-participant average among 4 other Cystinosis trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05508009, a Phase 1 study of Cystinosis and FSGS, is actively recruiting participants, sponsored by Alice Bertaina.

RECRUITING
Registry status
Phase 1
Development phase
12 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG Fludarabine
  • RADIATION Total Body Irradiation
  • DRUG ATG
  • DRUG Cyclophosphamide 1200 mg/Kg
  • DRUG Cyclophosphamide 100 mg/Kg

Study Locations (1)

California

  • Lucile Packard Children's Hospital - Palo Alto

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2023-01-10
Est. Completion 2034-10
Phase Phase 1

Sponsor

Alice Bertaina

2 total trials

What the Registry Record Tells You About NCT05508009

The ClinicalTrials.gov registry entry for NCT05508009 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 202-participant average among 4 other Cystinosis trials with a reported enrollment target (94% lower). The listed sponsor is Alice Bertaina, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Cystinosis appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.

NCT05508009 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT05508009 about?

NCT05508009 is a clinical study titled "Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor". 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...

What is the current status of trial NCT05508009?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2023-01-10. Estimated completion is 2034-10.

What conditions does trial NCT05508009 study?

This clinical trial studies the following conditions: Cystinosis, FSGS, SLE Nephritis, SIOD, CKD Stage 4.

What interventions are being tested in trial NCT05508009?

The interventions under investigation include: Fludarabine (DRUG), Total Body Irradiation (RADIATION), ATG (DRUG), Cyclophosphamide 1200 mg/Kg (DRUG), Cyclophosphamide 100 mg/Kg (DRUG).

Who is sponsoring clinical trial NCT05508009?

This trial is sponsored by Alice Bertaina, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05508009 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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