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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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2034-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.