Diclofenac dose uk 3 (6.6 g/day) and the two groups were not statistically different (P = 0.876). The total daily dose uk3 of the nefarglokumab group was significantly greater than the dose uk3 of diclofenac group (P = 0.025). However, neither treatment group had clinically significant increases in liver transaminases during the 12 hours after end of the study.
Because liver and kidney tissue can be considered as an end-point to assess nefarglokumab activity in patients with nephrotic syndrome, we hypothesized that the efficacy of nefarglokumab in these conditions would be lower than that reported in this study, as a surrogate endpoint. We investigated this finding by applying a sensitivity analysis involving the nefarglokumab endpoint (the change in the primary end-point for liver transaminases). The primary endpoint was not statistically different between baseline and diclofenac rezeptfrei apotheke the endpoint, 1 month after treatment (Figure 2C). Similarly, the primary endpoint for kidney transaminases also fell outside statistical boundaries and did not change (Figure 2D). Thus, the efficacy of nefarglokumab in liver and kidney may be lower than previously reported. There may be an upper limit to its beneficial activity in these end points.
We also hypothesized that the clinical benefit of nefarglokumab in our study could be explained by changes in nephrotic syndrome or a difference in disease activity and that our data were sufficient to exclude the possibility that nefarglokumab improved outcome in patients with severe nephrotic syndrome or other organ involvement secondary to nephrotic syndrome. However, our results for the primary endpoint kidney transaminases (which were not statistically different) are consistent with a difference in disease activity. Thus, while nefarglokumab showed a clinically effective clinical response in the liver, kidney and renal tissue, liver transaminase levels, a difference in the disease activity was not statistically significant.
The clinical benefit of nefarglokumab in this study was also associated with reductions in the clinical and biochemical parameters of renal disease. It is generally accepted that patients with nephrotic syndrome have elevated PTH and creatinine levels, which increase the risk of clinical renal dysfunction. The and biochemical reduction of renal disease observed in participants with azoospermia/polyuria as an end-point of our trial suggests that nefarglokumab may be effective in reducing the risk of clinical renal dysfunction associated with nephrotic syndrome. These results also explain why the clinical benefit of nefarglokumab in this population is higher than for adults with end-stage renal disease. In patients with end-stage renal disease or other involvement (e.g., glomerulonephritis peritubular hepatic necrosis), the overall efficacy of nefarglokumab in the acute phase (12 hours after drug initiation) was lower than in subjects without kidney involvement at baseline (Table 1).
Our data demonstrated that nefarglokumab improved clinical outcomes in adults who required renal replacement therapy. The clinical benefit of nefarglokumab in patients with renal failure, but without nephrotic syndrome or advanced hepatic disease, warrants further investigation in larger, randomized trials, especially because renal function is usually more stable and less affected by chronic inflammation than that of liver function.
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