An open-label study evaluating the safety and efficacy of budesonide in patients with IgA nephropathy at high risk of progression

Autor: Bogdan Obrișcă, Alexandra Vornicu, Valentin Mocanu, George Dimofte, Andreea Andronesi, Raluca Bobeică, Roxana Jurubiță, Bogdan Sorohan, Nicu Caceaune, Gener Ismail
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Scientific Reports, Vol 13, Iss 1, Pp 1-11 (2023)
Druh dokumentu: article
ISSN: 2045-2322
DOI: 10.1038/s41598-023-47393-1
Popis: Abstract We sought to evaluate the efficacy and safety of budesonide (Budenofalk) in the treatment of patients with IgA Nephropathy. We conducted a prospective, interventional, open-label, single-arm, non-randomized study that enrolled 32 patients with IgAN at high risk of progression (BUDIGAN study, ISRCTN47722295, date of registration 14/02/2020). Patients were treated with Budesonide at a dose of 9 mg/day for 12 months, subsequently tapered to 3 mg/day for another 12 months. The primary endpoints were change of eGFR and proteinuria at 12, 24 and 36 months. The study cohort had a mean eGFR and 24-h proteinuria of 59 ± 24 ml/min/1.73m2 and 1.89 ± 1.5 g/day, respectively. Treatment with budesonide determined a reduction in proteinuria at 12-, 24- and 36-months by -32.9% (95% CI − 53.6 to − 12.2), − 49.7% (95% CI − 70.1 to − 29.4) and − 68.1% (95% CI − 80.6 to − 55.7). Budesonide determined an eGFR preservation corresponding to a 12-, 24- and 36-months change of + 7.68% (95% CI − 4.7 to 20.1), + 7.42% (95% CI − 7.23 to 22.1) and + 4.74% (95%CI − 13.5 to 23), respectively. The overall eGFR change/year was + 0.83 ml/min/y (95% CI − 0.54 to 4.46). Budesonide was well-tolerated, and treatment emergent adverse events were mostly mild in severity and reversible. Budesonide was effective in the treatment of patients with IgAN at high-risk of progression in terms of reducing proteinuria and preserving renal function over 36 months of therapy.
Databáze: Directory of Open Access Journals
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