Home > Nephrology > ERA 2024 > Active vitamin D plus low-dose prednisolone is an alternative to high-dose prednisolone in minimal change disease

Active vitamin D plus low-dose prednisolone is an alternative to high-dose prednisolone in minimal change disease

Presented by
Dr Tilde Kristensen, Regional Hospital Viborg, Denmark
Conference
ERA 2024
Trial
ADAPTinMCN
Lower-dose prednisolone plus alfacalcidol is non-inferior in inducing remission with an improved safety profile compared with the guideline-recommended 1 mg/kg/day prednisolone, according to results from the ADAPTinMCN trial.

ADAPTinMCN (NCT03210688) is an ongoing investigator-initiated, Danish, multicentre, prospective, open-label, randomised, controlled trial including adult participants with biopsy-proven minimal change disease and nephrotic syndrome. Participants were randomised 1:1 to prednisolone 1 mg/kg/day or prednisolone 0.5 mg/kg/day plus 0.5 µg alfacalcidol. The primary endpoints were the rate of and time to remission, defined as urine albumin-creatinine ratio <300 mg/g and/or <400 mg/g present at 2 consecutive tests. A total of 35 participants were included per treatment group [1].

Remission was achieved in 89% of participants with high-dose prednisolone and 83% of participants receiving low-dose prednisolone plus alfacalcidol. The median time to remission was 23 days (interquartile range [IQR] 12–43) in the high-dose prednisolone group and 25 days (IQR 15–35 days) in the low-dose prednisolone plus alfacalcidol group. However, as expected, the median cumulative prednisolone doses were significantly lower in the low-dose prednisolone plus alfacalcidol group (1413 mg [IQR 834–2061] vs 2240 mg [IQR 1380–4310]; P=0.002). Nine treatment-related adverse events were reported in the high-dose group compared with only 1 in the low-dose prednisolone plus alfacalcidol group. Also, other, milder, treatment-related adverse events were more common in the high-dose prednisolone group. Finally, serum Ca2+ and vitamin D levels did not differ between treatment groups at baseline or remission.

“In participants with minimal change disease, treatment with low-dose prednisolone in combination with alfacalcidol is non-inferior to prednisolone 1 mg/kg/day”, concluded Dr Tilde Kristensen (Regional Hospital Viborg, Denmark). “The two treatment strategies are equally efficient regarding rate of remission and time to remission, and severe adverse events were more common in the high-dose group”. These results raise the question of whether guidelines regarding the treatment of minimal change disease in adults should be changed to low-dose prednisolone alternatives.

  1. Kristensen T, et al. Lower dose prednisolone and alfacalcidol is noninferior to high dose prednisolone in minimal change disease – a randomized controlled trial. Abstract #3, ERA 2024, 23–26 May, Stockholm, Sweden.

Medical writing support was provided by Mihai Surducan, PhD.

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