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Abstract: SA-PO891

An Open-Label Trial Evaluating the Safety and Efficacy of Budesonide in Patients with IgA Nephropathy at High Risk of Progression

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Obrisca, Bogdan, Fundeni Clinical Institute, Bucharest, Romania
  • Jurubita, Roxana Adriana, Fundeni Clinical Institute, Bucharest, Romania
  • Sorohan, Bogdan, Fundeni Clinical Institute, Bucharest, Romania
  • Andronesi, Andreea, Fundeni Clinical Institute, Bucharest, Romania
  • Vornicu, Alexandra, Fundeni Clinical Institute, Bucharest, Romania
  • Ismail, Gener, Fundeni Clinical Institute, Bucharest, Romania
Background

We sought to evaluate the efficacy and safety of budesonide (Budenofalk®) in the treatment of patients with IgA Nephropathy (IgAN).

Methods

The BUDIGAN trial (ISRCTN47722295) is a prospective, interventional, open-label, non-randomized study that enrolled 32 patients with IgAN, at high risk of progression defined as persistent proteinuria over 1 g/day despite adequate RAAS blockade for at least 3 months or patients with proteinuria between 0.5 and 1 g/day after RAAS blockade if they had additional risk factors for progression (eGFR<60 ml/min/1.73m2, presence of proliferative lesions). Patients were treated with Budenofalk® at a dose of 9 mg/day for the first 12 months, subsequently tapered to 3 mg/day for another 12 months. The primary endpoints were change of eGFR, proteinuria and hematuria at 36 months.

Results

The study cohort had a mean age of 41.7 ± 9.4 years (72% were males), while the mean eGFR and median 24-h proteinuria were 59 ± 24 ml/min/1.73m<span style="font-size:10.8333px">2</span> and 1.5 g/d (IQR:1.05-2.4), respectively. 25% and 12.5% of patients had a proteinuria level of 2-3.5 g/d and over 3.5 g/d, respectively. Treatment with budesonide determined a reduction in proteinuria at 12, 24 and 36 months by -42.3% (95%CI, -52.2 to -1.24), -61.5% (95%CI, -72.2 to -35.9) and -74.3% (95%CI, -80.6 to -55.7). The proteinuria at last follow-up was 0.34 g/d (IQR:0.12-0.86), significantly lower than the study baseline (p<0.001). The improvement in hematuria was similar to proteinuria with a reduction at 36 months by -92.6% (95%CI, -95 to -58.6). Budesonide treatment determined an eGFR preservation corresponding to a 12, 24 and 36 month change of +6.1% (95%CI, -9.5 to 21.7), +7.1% (95%CI, -10.2 to 24.3) and +4.7% (95%CI, -13.5 to 23), respectively. The overall eGFR change/year was +0.61 ml/min/y (95%CI, -1.37 to 2.59). Budesonide (Budenofalk®) was well-tolerated, and treatment emergent adverse events were mostly mild in severity and reversible.

Conclusion

Budesonide (Budenofalk) was effective in the treatment of patients with IgAN at high-risk of progression in terms of reducing proteinuria, hematuria and preserving renal function over 36 months of therapy.