Chapter 6-06: Key Clinical Trials and Publications in Nephrology

ACUTE KIDNEY INJURY

• STARRT-AKI. N Eng J Med 2020;383:240–251.

  • - Open-labeled, randomized, controlled trial among critically ill patients with AKI who were randomized 1:1 to accelerated versus standard initiation of renal replacement therapy. Accelerated renal replacement strategy did not improve 90-day mortality when compared to a standard strategy.

RENAL ARTERY STENOSIS

• CORAL. N Eng J Med 2014;370(1):13–22.

  • - Multicenter, randomized, controlled trial that randomized patients with severe atherosclerotic renal artery stenosis and hypertension or CKD to undergo renal artery stenting with optimal medical therapy vs. optimal medical therapy alone. Among patients with atherosclerotic renal artery stenosis and hypertension or CKD, renal artery stenting did not reduce risk of a composite cardiovascular and renal clinical outcome.

TIMING OF DIALYSIS INITIATION IN CKD

• IDEAL. N Eng J Med 2010;363(7):609–619.

  • - Multicenter randomized controlled trial that randomized adults with progressive CKD and eGFR <15 mL/min/1.73 m² to receive early initiation of dialysis vs. late initiation of diagnosis (usual care). Early initiation of dialysis did not improve survival, risk of CV events, or several dialysis-related outcomes when compared to initiation based on symptoms or eGFR <7.

HEMOGLOBIN TARGETS IN PATIENTS WITH CKD

• TREAT. N Eng J Med 2009;361(21):2019–2032.

  • - Multicenter, double-blinded, randomized, placebo-controlled trial that randomized patients with CKD, DM2, and anemia to receive darbepoetin or placebo. The darbepoetin group received therapy to maintain a Hg >13 g/dL, while the placebo group received rescue darbepoetin if hemoglobin fell below 9 g/dL. Targeting a hemoglobin of >13 g/dL with the use of erythrocyte-stimulating agents did not confer a survival benefit, but was associated with increased risk of stroke.

HYPERKALEMIA

• AMETHYST-DN. JAMA 2015;314(2):151–161.

  • - Phase 2 multicenter, open-label, dose-ranging, randomized controlled trial among patients with DM2, CKD, and hyperkalemia on RAAS inhibitors. Patients were stratified by baseline serum potassium and randomized to one of three starting doses of patiromer. Among these patients, patiromer starting doses of 4.2–16.8 g BID resulted in statistically significant decreases in serum potassium level after 4 weeks of treatment, lasting through 52 weeks.

SGLT2 INHIBITORS IN DIABETIC KIDNEY DISEASE

• CREDENCE. N Eng J Med 2019;380(24):2295–2306.

  • - Prospective, double-blind, randomized controlled trial that randomized patients with DM2, albuminuria, and reduced GFR to the SGLT2 inhibitor canagliflozin or placebo. Canagliflozin 100 mg/day reduced risk of kidney failure and cardiovascular events among these patients.

ACE INHIBITOR-ARB COMBINATION

• VA-NEPHRON D. N Eng J Med 2013;369(20):1892–1903.

  • - Multicenter, randomized, double-blind, placebo-controlled trial that randomized patients with diabetes with proteinuria to receive losartan 100 mg PO daily plus either lisinopril 10–40 mg PO daily or placebo. The addition of lisinopril to losartan did not prevent kidney function decline but did increase risk of hyperkalemia and AKI compared to losartan plus placebo. ...