Last reviewed · How we verify
NCT05525507
A Single-armed, Unblinded, Non-randomized Feasibility Study of Hematopoietic Stem Cell Infusion Following a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Anti-thymocyte Globulin (ATG) in Patients With a Pre-existing, Well-functioning HLA-matched Kidney Transplant
Phase 1 trial testing Conditioning and Stem cell infusion in End Stage Kidney Disease in 10 participants. Currently enrolling.
1 December 2026
Quick facts
| Lead sponsor | University of California, Los Angeles |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 21 December 2022 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Conditioning and Stem cell infusion
Conditions studied
- End Stage Kidney Disease — all drugs for End Stage Kidney Disease →
- Immunological Tolerance — all drugs for Immunological Tolerance →
- Kidney Transplant Failure and Rejection — all drugs for Kidney Transplant Failure and Rejection →
- Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
Sponsor
University of California, Los Angeles
Who can join
18 and older, any sex, with End Stage Kidney Disease or Immunological Tolerance. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Incidence of successful discontinuation of immunosuppression
Time frame: 12 months
To determine whether patients with pre-existing kidney transplants from a haploidentical living donor can be withdrawn from immunosuppressive drugs while maintaining stable graft function within 12 months of hematopoietic stem cell infusion from the same HLA-identical living donor, preceded by conditioning with TLI and ATG.
Sponsor's own description
The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
HLA Type and the Effect of HLA Antibodies in Kidney, Liver, and Pancreas Transplantation: A Review.
Zarei E, Roozbeh J, Nikoupour Deylami H, Nikeghbalian S, et al · · 2026 · PMID 42080115 · DOI 10.18502/ajmb.v18i1.21042
Verify or expand the search:
- PubMed search for NCT05525507
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for End Stage Kidney Disease
Currently open trials in the same condition.
- NCT06356168 — Virtual Reality in End Stage Kidney Disease · NA · recruiting
- NCT05715814 — meChANisms and sAfety of SGLT2 Inhibition in peRitoneal dialYsis · Phase 3 · recruiting
- NCT05642364 — Virtual Reality in Hemodialysis to Improve Psychological Well-being · NA · active not recruiting
- NCT05642156 — Hemodynamics in Chronic Hemodialysis Patients Undergoing Isolated Ultrafiltration Compared to Conventional Hemodialysis · NA · recruiting
- NCT05311956 — Pain Reduction Using NEurostimulation Study · NA · active not recruiting
Other University of California, Los Angeles trials
Trials by the same sponsor.
- NCT04846517 — rTMS for Aneroxia Nervosa in Youth · NA · not yet recruiting
- NCT06701760 — Sodium Lactate in Severe TBI · Phase 2 · not yet recruiting
- NCT04996667 — Effect of iNO in Patients With Submassive and Massive PE · Phase 2 · withdrawn
- NCT05067387 — Evaluation of Oral THC and CBD in Men and Women · Phase 1 · not yet recruiting
- NCT07534696 — Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05525507 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of California, Los Angeles
- Last refreshed: 21 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05525507.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing