THE DRUG DOCKETOn 21 October the agency added ravulizumab's fifth indication - cutting protein leakage in adults at risk of progression - but granted it on a surrogate alone, with no proof yet that it slows kidney decline.
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WHAT THE STUDY ACTUALLY SAYSThe final VISIONARY analysis shows Voyxact flattened the two-year eGFR slope to 0.3 versus a 4.2 mL/min decline on placebo, and cut the composite kidney endpoint to 0.4% of patients from 11.2%.
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WHAT THE STUDY ACTUALLY SAYSRAINIER's interim analysis found the dual APRIL/BAFF inhibitor cut urinary protein by 52% at nine months versus 4% on placebo, but the kidney-function answer is still years away.
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WHAT THE STUDY ACTUALLY SAYSORIGIN 3's final analysis found the APRIL/BAFF inhibitor stabilised kidney function and left 5.1% of patients progressing versus 17.8% on placebo, with none reaching dialysis, transplant or death on the drug.
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WHAT THE STUDY ACTUALLY SAYSThe complement inhibitor lowered urinary protein by 43% versus placebo at week 34 in the interim I CAN trial, extending a drug already used in rarer disorders to the kidney's most common immune disease.
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THE DRUG DOCKETOn 13 October the FDA extended Velphoro (sucroferric oxyhydroxide) to children aged 6 to 9 on dialysis and added a 250 mg chewable tablet, widening an iron-based binder previously limited to patients 9 and older.
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WHAT THE STUDY ACTUALLY SAYSAcross 27 trials and 88,830 people, each 10-mmHg drop in systolic pressure cut cardiovascular events whether or not the kidneys were impaired — while aggressive lowering nudged up short-term markers of kidney decline.
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WHAT THE STUDY ACTUALLY SAYSA randomised Asian trial in 130 patients found no efficacy gap between the two drug regimens for active lupus nephritis, but serious infections and all three deaths fell in the mycophenolate group.
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WHAT THE STUDY ACTUALLY SAYSThe TRACK trial was stopped early for futility. The blood thinner failed to reduce a composite of cardiovascular events, while major bleeding rose by half. Bayer, which makes the drug, was a listed collaborator.
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WHAT THE STUDY ACTUALLY SAYSIn the 1,658-person PUSH trial, a behavioural programme with financial incentives raised urine volume but left symptomatic stone recurrences unchanged over two years — 19% against 20% with usual care.
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WHAT THE STUDY ACTUALLY SAYSFinal ALIGN results show the endothelin blocker preserved kidney function over 2.5 years in a rare kidney disease, yet the difference at week 136 just missed statistical significance (p=0.057).
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WHAT THE STUDY ACTUALLY SAYSIn the FIND-CKD trial, non-diabetic patients on finerenone lost kidney function at 3.3 versus 4.0 ml/min/1.73 m² a year — a small edge that extends a diabetes drug to a new group.
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WHAT THE STUDY ACTUALLY SAYSIn 1,362 Shanghai dialysis patients followed for over three years, hemoadsorption plus haemodialysis lowered all-cause mortality versus dialysis alone — a borderline result from an open-label trial.
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THE DRUG DOCKETVoyxact cut urinary protein by about half at nine months in the VISIONARY trial. Whether that slows kidney decline is the question the accelerated approval leaves open until 2027.
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ANALYSISPooling individual data from 23,340 people in four trials, empagliflozin cut kidney failure by 34% and slowed eGFR decline by 64% — regardless of how big an initial creatinine rise was expected.
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