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

Low-dose prednisolone plus alfacalcidol is non-inferior in inducing remission but presents with fewer adverse events compared with the guideline-recommended high-dose 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 and Dr Tilde Kristensen (Regional Hospital Viborg, Denmark) presented the results [1].

Remission was achieved in 89% of participants with high-dose prednisolone and 83% 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 (AEs) were reported in the high-dose group compared with only one in the low-dose prednisolone plus alfacalcidol group. Also, other, milder, treatment-related AEs 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 Kristensen. “The two treatment strategies are equally efficient regarding the rate-of-remission and time-to-remission, but severe AEs were more common in the high-dose group”. These results raise the question of whether guidelines for 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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Posted on 20 June 202424 June 2024