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Clinical Trial
. 2023 Nov 17;13(1):20119.
doi: 10.1038/s41598-023-47393-1.

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

Bogdan Obrișcă  1   2 , Alexandra Vornicu  3   4 , Valentin Mocanu  4 , George Dimofte  4 , Andreea Andronesi  3   4 , Raluca Bobeică  4 , Roxana Jurubiță  3   4 , Bogdan Sorohan  3   4 , Nicu Caceaune  5 , Gener Ismail  3   4
Affiliations
Clinical Trial

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

Bogdan Obrișcă et al. Sci Rep. .

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.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Study flow-chart.
Figure 2
Figure 2
eGFR and proteinuria evolution.
Figure 3
Figure 3
Proteinuria evolution according to study subgroups. (A) Patients with 24-h proteinuria < 2 g/d; (B) Patients with 24-h proteinuria 2–3.5 g/d; (C) Patients with 24-h proteinuria > 3.5 g/d; (D) Proteinuria evolution according to baseline eGFR; (E) Percentage reduction of proteinuria according to baseline eGFR.
Figure 4
Figure 4
eGFR evolution. (A) According to baseline eGFR; (B) According to baseline 24-h proteinuria.
Figure 5
Figure 5
Hematuria evolution and individual eGFR evolution.
Figure 6
Figure 6
Blood glucose and mean arterial pressure evolution.
See this image and copyright information in PMC

References

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