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NCT05092347
A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)
Phase 1, PHASE2 trial testing Vonsetamig in Chronic Kidney Disease (CKD) in 56 participants. Currently enrolling.
24 March 2026
Quick facts
| Lead sponsor | Regeneron Pharmaceuticals |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 2 August 2022 |
| Primary completion | 24 March 2026 |
| Estimated completion | 1 September 2027 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- Vonsetamig — full drug profile →
Conditions studied
- Chronic Kidney Disease (CKD) — all drugs for Chronic Kidney Disease (CKD) →
Sponsor
Regeneron Pharmaceuticals — full company profile →
Who can join
Adults 18 to 70, any sex, with Chronic Kidney Disease (CKD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine whether vonsetamig will safely decrease anti-HLA antibodies to allow for kidney transplantation. Vonsetamig is being studied for treatment of patients in need of kidney transplantation who are highly sensitized to HLA. The study is looking at several other research questions, including: * Side effects that may be experienced from taking vonsetamig * How vonsetamig works in the body * How much vonsetamig is present in the blood * If vonsetamig works to lower levels of antibodies to HLA
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunotherapy targeting B cells and long-lived plasma cells effectively eliminates pre-existing donor-specific allo-antibodies.
Zhang Z, Markmann C, Yu M, Agarwal D, et al · · 2023 · cited 12× · PMID 38118406 · DOI 10.1016/j.xcrm.2023.101336 -
New Therapies for Highly Sensitized Patients on the Waiting List.
Vo A, Ammerman N, Jordan SC. · · 2024 · cited 9× · PMID 38995690 · DOI 10.34067/kid.0000000000000509 -
Novel insights in the clinical management of hyperimmune patients before and after transplantation.
Grimaldi V, Pagano M, Moccia G, Maiello C, et al · · 2023 · cited 7× · PMID 36714552 · DOI 10.1016/j.crimmu.2023.100056 -
Elranatamab treatment in a multiple myeloma patient undergoing renal dialysis.
Van de Wyngaert Z, Romera-Martinez I, Chedeville C, Musiu P, et al · · 2024 · cited 6× · PMID 38817306 · DOI 10.46989/001c.116800 -
Poised for Innovation: Considerations for End Points for New Drug Development in Kidney Transplantation.
Mannon RB, Vincenti FG. · · 2024 · cited 1× · PMID 39102302 · DOI 10.1681/asn.0000000000000475
Verify or expand the search:
- PubMed search for NCT05092347
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Vonsetamig
Trials testing the same drug.
- NCT06975787 — Dose Escalation Study With Bispecific Antibodies in Adult Patients With Lupus Nephritis · Phase 1 · recruiting
Other recruiting trials for Chronic Kidney Disease (CKD)
Currently open trials in the same condition.
- NCT07493642 — Multimedia Health Education on Physical Fitness and Physical Activity for Patients With Chronic Kidney Disease · NA · recruiting
- NCT07106879 — Non-interventional Pre-screening Protocol Aims to Evaluate Participants for Potential Trial Eligibility in Future Clinic · recruiting
- NCT06607913 — Exercise and Monitoring With Post-Hospitalization Muscle Atrophy to Sustain Intrinsic Capacity and Strength · NA · recruiting
- NCT06635590 — Chronic Kidney Disease, Hyperkalemia and Echocardiographic Changes · recruiting
- NCT05106387 — An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant · recruiting
Other Regeneron Pharmaceuticals trials
Trials by the same sponsor.
- NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
- NCT07526116 — A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a Single Dose of REGN22044 in Healthy Adul · Phase 1 · not yet recruiting
- NCT07527923 — First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis · Phase 1 · not yet recruiting
- NCT07527910 — A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD · Phase 2 · not yet recruiting
- NCT07477704 — A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemi · Phase 2 · 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 NCT05092347 (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 Regeneron Pharmaceuticals
- Last refreshed: 12 February 2026
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/NCT05092347.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing