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Lumasiran for Advanced Primary Hyperoxaluria Type 1: Phase 3 ILLUMINATE-C Trial
- Source :
- American journal of kidney diseases, 81(2), 145-155.e1. W.B. Saunders Ltd, American journal of kidney diseases : the official journal of the National Kidney Foundation, Vol. 81, no.2, p. 145-155.e1 (2023), American Journal of Kidney Diseases, (2022), American Journal of Kidney Diseases, American Journal of Kidney Diseases, 2022, S0272-6386 (22), pp.00771-5. ⟨10.1053/j.ajkd.2022.05.012⟩
- Publication Year :
- 2023
- Publisher :
- Elsevier BV, 2023.
-
Abstract
- Rationale & Objective: Lumasiran reduces urinary and plasma oxalate (POx) in patients with primary hyperoxaluria type 1 (PH1) and relatively preserved kidney function. ILLUMINATE-C evaluates the efficacy, safety, pharmacokinetics, and pharmacodynamics of lumasiran in patients with PH1 and advanced kidney disease. Study Design: Phase 3, open-label, single-arm trial. Setting & Participants: Multinational study; enrolled patients with PH1 of all ages, estimated glomerular filtration rate ≤45 mL/min/1.73 m2 (if age ≥12 months) or increased serum creatinine level (if age
- Subjects :
- Adult
Male
RNA interference (RNAi)
safety
Lumasiran
urinary oxalate (UOx)
Adolescent
[SDV]Life Sciences [q-bio]
kidney disease
efficacy
Young Adult
nephrocalcinosis
glycolate
pharmacodynamics
Humans
Child
Hyperoxaluria
Oxalates
systemic oxalosis
hemodialysis
cardiac dysfunction
phase 3 clinical trial
Infant, Newborn
Infant
Middle Aged
adverse events
primary hyperoxaluria type 1 (PH1)
[SDV] Life Sciences [q-bio]
plasma oxalate (POx)
anti-drug antibodies
pediatric
Nephrology
Child, Preschool
Hyperoxaluria, Primary
Female
Kidney Diseases
pharmacokinetics
Subjects
Details
- ISSN :
- 02726386 and 15236838
- Volume :
- 81
- Database :
- OpenAIRE
- Journal :
- American Journal of Kidney Diseases
- Accession number :
- edsair.doi.dedup.....e766f52870784a99182763b902908469