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NCT03763643
PRI-VENT FSGS: Preemptive Rituximab to Prevent Recurrent Focal Segmental Glomerulosclerosis Post-Transplant
EARLY_PHASE1 trial testing Rituximab in Focal Segmental Glomerulosclerosis in 21 participants. Completed in 7 February 2025.
7 February 2025
Quick facts
| Lead sponsor | University of Minnesota |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 21 |
| Start date | 1 July 2019 |
| Primary completion | 7 February 2025 |
| Estimated completion | 7 February 2025 |
| Sites | 12 locations across United States |
Drugs / interventions tested
- Rituximab — full drug profile →
- Plasmapheresis — full drug profile →
Conditions studied
- Focal Segmental Glomerulosclerosis — all drugs for Focal Segmental Glomerulosclerosis →
Sponsor
University of Minnesota
Who can join
Adults 1 to 65, any sex, with Focal Segmental Glomerulosclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a pilot/feasibility, multicenter, randomized, open label, clinical trial to test that hypothesis that plasmapheresis plus rituximab prior to or at the time of kidney transplantation can prevent recurrent FSGS in children and adults.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recurrent Glomerular Disease after Kidney Transplantation: Diagnostic and Management Dilemmas.
Uffing A, Hullekes F, Riella LV, Hogan JJ. · · 2021 · cited 43× · PMID 34686531 · DOI 10.2215/cjn.00280121 -
Rituximab or plasmapheresis for prevention of recurrent focal segmental glomerulosclerosis after kidney transplantation: A systematic review and meta-analysis.
Boonpheng B, Hansrivijit P, Thongprayoon C, Mao SA, et al · · 2021 · cited 18× · PMID 34316454 · DOI 10.5500/wjt.v11.i7.303 -
A randomized controlled trial of preemptive rituximab to prevent recurrent focal segmental glomerulosclerosis post-kidney transplant (PRI-VENT FSGS): protocol and study design.
Rheault MN, Amaral S, Bock M, Chambers ET, et al · · 2023 · cited 7× · PMID 37675355 · DOI 10.3389/fneph.2023.1181076 -
Advances in Focal Segmental Glomerulosclerosis Treatment From the Perspective of the Newest Mechanisms of Podocyte Injury.
Zhu Y, Xu G. · · 2025 · cited 2× · PMID 39935575 · DOI 10.2147/dddt.s498457 -
Post-transplant glomerular diseases: update on pathophysiology, risk factors and management strategies.
Regalia A, Abinti M, Alfieri CM, Campise M, et al · · 2024 · cited 1× · PMID 39664990 · DOI 10.1093/ckj/sfae320 -
Recurrence of focal segmental glomerulosclerosis: An updated review of pathophysiology, biomarkers, and therapeutic strategies.
Oatley Z, Jaber D, Rayarakula N, Guirguis T, et al · · 2026 · PMID 41906863 · DOI 10.1177/09636897261417049
Verify or expand the search:
- PubMed search for NCT03763643
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Focal Segmental Glomerulosclerosis
Currently open trials in the same condition.
- NCT06664814 — An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Primary Focal Segmental Glomeruloscleros · Phase 2 · recruiting
- NCT07220083 — A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosc · Phase 3 · recruiting
- NCT06500702 — A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Ye · Phase 2 · recruiting
- NCT05942625 — A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10390 in Healthy Subjects · Phase 1 · recruiting
- NCT05588063 — taVNS for FRNS in Children · NA · recruiting
Other University of Minnesota trials
Trials by the same sponsor.
- NCT02421497 — MRI Technical Development and Applications in Kidney Disease · not yet recruiting
- NCT04100109 — Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic · NA · withdrawn
- NCT05454306 — Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures · NA · withdrawn
- NCT03192007 — Multi-Parametric MRI for Renal Transplantation · not yet recruiting
- NCT04940533 — Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers · 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 NCT03763643 (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 Minnesota
- Last refreshed: 10 September 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/NCT03763643.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing