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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: Recruiting Phase 1 study of Cystinosis and FSGS, sponsored by Alice Bertaina.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Donor chimerism equal or greater to 95% after successful HSCT/KT therapy allows for withdrawal of immunosuppressive therapy in patient
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 |
What NCT05508009 shows while recruiting
NCT05508009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 202-participant average among 4 other Cystinosis trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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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