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2Min Read

Safety and efficacy of sparsentan versus irbesartan in patients with IgA nephropathy

According to a recent study, treatment with sparsentan as opposed to maximally titrated irbesartan, led to significant reductions in proteinuria and the preservation of kidney function in IgA nephropathy individuals. This study’s findings were published in the journal, Lancet.

In this double-blind, randomised, active-controlled study, 406 patients with biopsy-proven primary IgA nephropathy and proteinuria were enrolled. These patients were randomly assigned in a 1:1 ratio to receive either sparsentan (400 mg oral sparsentan once daily) or irbesartan (300 mg oral irbesartan once daily). The primary endpoint of the study was to compare the change in proteinuria between the two treatment groups at 36 weeks. Secondary endpoints included the rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite outcome of kidney failure, as well as monitoring safety and tolerability for up to 110 weeks from randomisation.

Sparsentan group patients exhibited a slower rate of decline in eGFR compared to irbesartan group patients. A consistent reduction was seen in proteinuria at 36 weeks with sparsentan which was maintained throughout the entire study duration. At 110 weeks, the sparsentan group had a 40% lower proteinuria compared to the irbesartan group (-42.8% with sparsentan versus -4.4% with irbesartan). Additionally, the composite kidney failure endpoint was reached by 9% of patients in the sparsentan group compared to 13% of patients in the irbesartan group. The occurrence of adverse events during treatment was well balanced between sparsentan and irbesartan groups, with no new safety signals.

This study showed that over a period of 110 weeks, patients with IgA nephropathy who were treated with sparsentan exhibited significant decreases in proteinuria and the preservation of kidney function, in comparison to individuals who received maximally titrated irbesartan.

15 Mar 2024

Safety and efficacy of sparsentan versus irbesartan in patients with IgA nephropathy

According to a recent study, treatment with sparsentan as opposed to maximally titrated irbesartan, led to significant reductions in proteinuria and the preservation of kidney function in IgA nephropathy individuals. This study’s findings were published in the journal, Lancet.

In this double-blind, randomised, active-controlled study, 406 patients with biopsy-proven primary IgA nephropathy and proteinuria were enrolled. These patients were randomly assigned in a 1:1 ratio to receive either sparsentan (400 mg oral sparsentan once daily) or irbesartan (300 mg oral irbesartan once daily). The primary endpoint of the study was to compare the change in proteinuria between the two treatment groups at 36 weeks. Secondary endpoints included the rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite outcome of kidney failure, as well as monitoring safety and tolerability for up to 110 weeks from randomisation.

Sparsentan group patients exhibited a slower rate of decline in eGFR compared to irbesartan group patients. A consistent reduction was seen in proteinuria at 36 weeks with sparsentan which was maintained throughout the entire study duration. At 110 weeks, the sparsentan group had a 40% lower proteinuria compared to the irbesartan group (-42.8% with sparsentan versus -4.4% with irbesartan). Additionally, the composite kidney failure endpoint was reached by 9% of patients in the sparsentan group compared to 13% of patients in the irbesartan group. The occurrence of adverse events during treatment was well balanced between sparsentan and irbesartan groups, with no new safety signals.

This study showed that over a period of 110 weeks, patients with IgA nephropathy who were treated with sparsentan exhibited significant decreases in proteinuria and the preservation of kidney function, in comparison to individuals who received maximally titrated irbesartan.

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Safety and efficacy of sparsentan versus irbesartan in patients with IgA nephropathy

According to a recent study, treatment with sparsentan as opposed to maximally titrated irbesartan, led to significant reductions in proteinuria and the preservation of kidney function in IgA nephropathy individuals. This study’s findings were published in the journal, Lancet.

In this double-blind, randomised, active-controlled study, 406 patients with biopsy-proven primary IgA nephropathy and proteinuria were enrolled. These patients were randomly assigned in a 1:1 ratio to receive either sparsentan (400 mg oral sparsentan once daily) or irbesartan (300 mg oral irbesartan once daily). The primary endpoint of the study was to compare the change in proteinuria between the two treatment groups at 36 weeks. Secondary endpoints included the rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite outcome of kidney failure, as well as monitoring safety and tolerability for up to 110 weeks from randomisation.

Sparsentan group patients exhibited a slower rate of decline in eGFR compared to irbesartan group patients. A consistent reduction was seen in proteinuria at 36 weeks with sparsentan which was maintained throughout the entire study duration. At 110 weeks, the sparsentan group had a 40% lower proteinuria compared to the irbesartan group (-42.8% with sparsentan versus -4.4% with irbesartan). Additionally, the composite kidney failure endpoint was reached by 9% of patients in the sparsentan group compared to 13% of patients in the irbesartan group. The occurrence of adverse events during treatment was well balanced between sparsentan and irbesartan groups, with no new safety signals.

This study showed that over a period of 110 weeks, patients with IgA nephropathy who were treated with sparsentan exhibited significant decreases in proteinuria and the preservation of kidney function, in comparison to individuals who received maximally titrated irbesartan.

15 Mar 2024
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2Min Read

Vitamin D supplementation safe and effective in improving anemia in patients with end-stage renal disease

According to a recent study, vitamin D supplementation helps improve anemia in patients with end-stage renal disease (ESRD) on maintenance hemodialysis (HD). This study was published in the journal, Hemodialysis International.

This study was a double-blind, randomized, controlled trial that included 100 anemic HD patients, having vitamin D deficiency. They were randomly divided into two groups in a 1:1 ratio, using the closed envelop method. The first group was administered 50,000 IU vitamin D monthly for 6 months while the other group received a placebo for the same period. 25-Hydroxyvitamin D (25(OH)D) levels were measured at the beginning and end of the study after 6 months for both the groups. Hemoglobin (Hb) concentrations were recorded on a monthly basis.

At the end of 6 months, it was observed that vitamin D supplementation increased 25(OH)D levels in the vitamin D group more when compared to the placebo group. Similarly, Hb concentration increased more in the vitamin D group compared to the placebo group over the period of the study. Erythropoietin (EPO) dosage requirements were found to be lower in the vitamin D group than in the placebo group, which was statistically significant.

From the above results, it can be concluded that vitamin D supplementation in anemic ESRD patients on HD is safe and effective in improving anemia and decreasing EPO dosage.

11 Mar 2024

Vitamin D supplementation safe and effective in improving anemia in patients with end-stage renal disease

According to a recent study, vitamin D supplementation helps improve anemia in patients with end-stage renal disease (ESRD) on maintenance hemodialysis (HD). This study was published in the journal, Hemodialysis International.

This study was a double-blind, randomized, controlled trial that included 100 anemic HD patients, having vitamin D deficiency. They were randomly divided into two groups in a 1:1 ratio, using the closed envelop method. The first group was administered 50,000 IU vitamin D monthly for 6 months while the other group received a placebo for the same period. 25-Hydroxyvitamin D (25(OH)D) levels were measured at the beginning and end of the study after 6 months for both the groups. Hemoglobin (Hb) concentrations were recorded on a monthly basis.

At the end of 6 months, it was observed that vitamin D supplementation increased 25(OH)D levels in the vitamin D group more when compared to the placebo group. Similarly, Hb concentration increased more in the vitamin D group compared to the placebo group over the period of the study. Erythropoietin (EPO) dosage requirements were found to be lower in the vitamin D group than in the placebo group, which was statistically significant.

From the above results, it can be concluded that vitamin D supplementation in anemic ESRD patients on HD is safe and effective in improving anemia and decreasing EPO dosage.

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Vitamin D supplementation safe and effective in improving anemia in patients with end-stage renal disease

According to a recent study, vitamin D supplementation helps improve anemia in patients with end-stage renal disease (ESRD) on maintenance hemodialysis (HD). This study was published in the journal, Hemodialysis International.

This study was a double-blind, randomized, controlled trial that included 100 anemic HD patients, having vitamin D deficiency. They were randomly divided into two groups in a 1:1 ratio, using the closed envelop method. The first group was administered 50,000 IU vitamin D monthly for 6 months while the other group received a placebo for the same period. 25-Hydroxyvitamin D (25(OH)D) levels were measured at the beginning and end of the study after 6 months for both the groups. Hemoglobin (Hb) concentrations were recorded on a monthly basis.

At the end of 6 months, it was observed that vitamin D supplementation increased 25(OH)D levels in the vitamin D group more when compared to the placebo group. Similarly, Hb concentration increased more in the vitamin D group compared to the placebo group over the period of the study. Erythropoietin (EPO) dosage requirements were found to be lower in the vitamin D group than in the placebo group, which was statistically significant.

From the above results, it can be concluded that vitamin D supplementation in anemic ESRD patients on HD is safe and effective in improving anemia and decreasing EPO dosage.

11 Mar 2024
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2Min Read

Efficacy of darbepoetin alfa administered subcutaneously every other week in maintaining hemoglobin in Chronic Kidney Disease

According to a recent study, chronic kidney disease patients who received once-weekly (QW) recombinant human erythropoietin (rHuEPO), effectively converted to darbepoetin alfa administered subcutaneously every other week (Q2W), which was well tolerated. This study was published in the American Journal of Nephrology .

The STAAR (Simplify the Treatment of Anemia with Aranesp) was a multicenter, 52-week study that enrolled 524 subjects. The subgroup analysis of subjects who were on QW rHuEPO, were converted to 52-weeks of darbepoetin alfa therapy, administered subcutaneously. These subjects had either creatinine clearance < or = 70 ml/min or transferrin saturation > or = 20% and an estimated glomerular filtration rate < or = 60 ml/min. The primary endpoint of the study was mean Hb during evaluation.

It was found that the mean Hb +/- standard deviation was 11.2 +/- 1.27 g/dl at baseline while the least squares mean +/- SE was 11.4 +/- 0.04 during evaluation. Also, the mean +/- SD Q2W darbepoetin alfa dose was 49.7 +/- 21.9 microg and 48.9 +/- 35.5 microg at baseline and evaluation, respectively.

From the above results, it can be concluded that darbepoetin alfa was well tolerated in subjects who had chronic kidney disease, who were receiving QW rHuEPO and were effectively converted to Q2W darbepoetin alfa.

04 Jan 2024

Efficacy of darbepoetin alfa administered subcutaneously every other week in maintaining hemoglobin in Chronic Kidney Disease

According to a recent study, chronic kidney disease patients who received once-weekly (QW) recombinant human erythropoietin (rHuEPO), effectively converted to darbepoetin alfa administered subcutaneously every other week (Q2W), which was well tolerated. This study was published in the American Journal of Nephrology .

The STAAR (Simplify the Treatment of Anemia with Aranesp) was a multicenter, 52-week study that enrolled 524 subjects. The subgroup analysis of subjects who were on QW rHuEPO, were converted to 52-weeks of darbepoetin alfa therapy, administered subcutaneously. These subjects had either creatinine clearance < or = 70 ml/min or transferrin saturation > or = 20% and an estimated glomerular filtration rate < or = 60 ml/min. The primary endpoint of the study was mean Hb during evaluation.

It was found that the mean Hb +/- standard deviation was 11.2 +/- 1.27 g/dl at baseline while the least squares mean +/- SE was 11.4 +/- 0.04 during evaluation. Also, the mean +/- SD Q2W darbepoetin alfa dose was 49.7 +/- 21.9 microg and 48.9 +/- 35.5 microg at baseline and evaluation, respectively.

From the above results, it can be concluded that darbepoetin alfa was well tolerated in subjects who had chronic kidney disease, who were receiving QW rHuEPO and were effectively converted to Q2W darbepoetin alfa.

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Efficacy of darbepoetin alfa administered subcutaneously every other week in maintaining hemoglobin in Chronic Kidney Disease

According to a recent study, chronic kidney disease patients who received once-weekly (QW) recombinant human erythropoietin (rHuEPO), effectively converted to darbepoetin alfa administered subcutaneously every other week (Q2W), which was well tolerated. This study was published in the American Journal of Nephrology .

The STAAR (Simplify the Treatment of Anemia with Aranesp) was a multicenter, 52-week study that enrolled 524 subjects. The subgroup analysis of subjects who were on QW rHuEPO, were converted to 52-weeks of darbepoetin alfa therapy, administered subcutaneously. These subjects had either creatinine clearance < or = 70 ml/min or transferrin saturation > or = 20% and an estimated glomerular filtration rate < or = 60 ml/min. The primary endpoint of the study was mean Hb during evaluation.

It was found that the mean Hb +/- standard deviation was 11.2 +/- 1.27 g/dl at baseline while the least squares mean +/- SE was 11.4 +/- 0.04 during evaluation. Also, the mean +/- SD Q2W darbepoetin alfa dose was 49.7 +/- 21.9 microg and 48.9 +/- 35.5 microg at baseline and evaluation, respectively.

From the above results, it can be concluded that darbepoetin alfa was well tolerated in subjects who had chronic kidney disease, who were receiving QW rHuEPO and were effectively converted to Q2W darbepoetin alfa.

04 Jan 2024
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2Min Read

Dose reduction conversion from epoetin to darbepoetin alfa in patients undergoing dialysis

According to a recent study conducted in patients undergoing dialysis, a dose reduction conversion from epoetin to darbepoetin alfa using the starting dose conversion of 200:1, helped achieve a 30% dose savings. This study was published in the journal, NDT Plus.

This meta-analysis was done after sourcing articles from Medline and EmBase in order to find out all published trials investigating Erythropoiesis-stimulating agents (ESAs) for treatment in anaemic patients receiving dialysis. Prospective randomized controlled, non-randomized and observational studies that included patients on dialysis and which compared epoetin and darbepoetin alfa dosing were selected. Out of 573 articles, 9 studies fulfilled the eligibility criteria and were included in the analysis. Target haemoglobin levels were maintained before and after conversion in all the studies.

From the meta-analysis, it was found out that overall percentage dose savings attained was 30% when dialysis patients were converted from epoetin to darbepoetin alfa. Intravenous administration (33%) showed greater dose savings when compared to subcutaneous (27%) and between switch-over studies (31%) and RCTs (27%).

Based on the findings, it can be concluded that using an initial 200:1 conversion ratio, as indicated by the European Medicines Agency, after conversion from epoetin to darbepoetin alfa, an average 30% dose savings could be achieved through subsequent reduction in dose.

02 Jan 2024

Dose reduction conversion from epoetin to darbepoetin alfa in patients undergoing dialysis

According to a recent study conducted in patients undergoing dialysis, a dose reduction conversion from epoetin to darbepoetin alfa using the starting dose conversion of 200:1, helped achieve a 30% dose savings. This study was published in the journal, NDT Plus.

This meta-analysis was done after sourcing articles from Medline and EmBase in order to find out all published trials investigating Erythropoiesis-stimulating agents (ESAs) for treatment in anaemic patients receiving dialysis. Prospective randomized controlled, non-randomized and observational studies that included patients on dialysis and which compared epoetin and darbepoetin alfa dosing were selected. Out of 573 articles, 9 studies fulfilled the eligibility criteria and were included in the analysis. Target haemoglobin levels were maintained before and after conversion in all the studies.

From the meta-analysis, it was found out that overall percentage dose savings attained was 30% when dialysis patients were converted from epoetin to darbepoetin alfa. Intravenous administration (33%) showed greater dose savings when compared to subcutaneous (27%) and between switch-over studies (31%) and RCTs (27%).

Based on the findings, it can be concluded that using an initial 200:1 conversion ratio, as indicated by the European Medicines Agency, after conversion from epoetin to darbepoetin alfa, an average 30% dose savings could be achieved through subsequent reduction in dose.

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Dose reduction conversion from epoetin to darbepoetin alfa in patients undergoing dialysis

According to a recent study conducted in patients undergoing dialysis, a dose reduction conversion from epoetin to darbepoetin alfa using the starting dose conversion of 200:1, helped achieve a 30% dose savings. This study was published in the journal, NDT Plus.

This meta-analysis was done after sourcing articles from Medline and EmBase in order to find out all published trials investigating Erythropoiesis-stimulating agents (ESAs) for treatment in anaemic patients receiving dialysis. Prospective randomized controlled, non-randomized and observational studies that included patients on dialysis and which compared epoetin and darbepoetin alfa dosing were selected. Out of 573 articles, 9 studies fulfilled the eligibility criteria and were included in the analysis. Target haemoglobin levels were maintained before and after conversion in all the studies.

From the meta-analysis, it was found out that overall percentage dose savings attained was 30% when dialysis patients were converted from epoetin to darbepoetin alfa. Intravenous administration (33%) showed greater dose savings when compared to subcutaneous (27%) and between switch-over studies (31%) and RCTs (27%).

Based on the findings, it can be concluded that using an initial 200:1 conversion ratio, as indicated by the European Medicines Agency, after conversion from epoetin to darbepoetin alfa, an average 30% dose savings could be achieved through subsequent reduction in dose.

02 Jan 2024
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