By Beth Gilbert HealthDay Reporter
The annual meeting of the American Society of Nephrology (Kidney Week) was held this year from Nov. 5 to 9 in Houston, attracting attendees from around the world, including nephrology specialists, researchers, scientists, and other health care professionals. The conference featured presentations focusing on the latest advances in the management of patients with kidney diseases and related disorders.
In one study, Daniel Gale, Ph.D., of University College London, and colleagues showed that an NADPH oxidase synthase (NOX) 1/4 inhibitor, setanaxib, has an acceptable safety profile, with some evidence of reduced proteinuria among patients with Alport syndrome.
The researchers analyzed the safety and efficacy of setanaxib in Alport syndrome. In a 2:1 randomized controlled trial of 20 patients, 24 weeks of treatment was well tolerated, and there was some evidence of reduced proteinuria in the treatment group compared with placebo. The study was a small phase 2a exploratory study and none of the differences observed were statistically significant.
“We conclude that these results justify a further (larger and longer) randomized controlled study to quantify the safety and efficacy of this drug to treat people with Alport syndrome,” Gale said.
The study was funded by Calliditas Therapeutics, which is developing setanaxib.
Abstract No. SA-OR082
In another study, Charmaine E. Lok, M.D., of the University Health Network in Toronto, and colleagues found that daily oral supplementation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in the form of fish oil is safe and reduces the rate of serious cardiovascular events in patients with kidney failure on maintenance hemodialysis.
As part of the PISCES study, 1,228 patients who were treated with chronic hemodialysis were randomly assigned to oral daily fish oil or placebo capsules.
The investigators found that the rate of serious cardiovascular events (heart attack, stroke, peripheral vascular disease leading to amputation, and cardiac death) was reduced by approximately 40 percent in patients treated with maintenance hemodialysis who received daily oral supplementation of 4 g of fish oil (total EPA, 1.6 g; total DHA, 0.8 g) compared with placebo. The rate of serious cardiovascular events was 0.31/1,000 days in the fish oil group versus 0.61/1,000 days in the placebo group. Adverse events, including bleeding, did not differ between the groups.
“Given the underlying high risk of cardiovascular events, lack of other preventative measures, and safety of fish oil, I would not be surprised if there is quick uptake of fish oil supplementation in patients receiving hemodialysis,” Lok said. “It should be emphasized that the dose and formulation of fish oil, and how it is taken, is important.”
Abstract No. FR-OR082
Natalie Staplin, Ph.D., of the University of Oxford Medical Sciences Division in the United Kingdom, and colleagues demonstrated clear absolute benefits of sodium-glucose cotransporter 2 (SGLT2) inhibitors on kidney, hospitalization, and mortality outcomes irrespective of diabetes status and level of urine albumin-to-creatinine ratio.
The authors conducted a meta-analysis of 58,816 participants enrolled in eight large randomized trials of SGLT2 inhibitors, including empagliflozin, dapagliflozin, and canagliflozin, compared with placebo.
The investigators found that SGLT2 inhibitors substantially reduced the risks for kidney disease progression, acute kidney injury, hospitalization, and death among individuals with and without diabetes and across all levels of albuminuria. Compared with placebo, allocation to SGLT2 inhibition reduced the hazard of kidney disease progression by 35 percent among participants with diabetes and 26 percent among participants without diabetes. Allocation to SGLT2 inhibition reduced the risk for acute kidney injury to a similar extent in participants with and without diabetes by 23 and 28 percent, respectively. The risk for hospitalization for heart failure was 32 and 25 percent lower in people with and without diabetes, respectively, who were allocated to an SGLT2 inhibitor, and the risk for any hospitalization was reduced by 10 and 11 percent, respectively.
People with lower albumin levels, who are often at lower risk for kidney failure, experienced benefit as a result of taking an SGLT2 inhibitor, particularly through reduced hospital admissions for heart failure and any other cause. Participants with higher albuminuria (≥200 mg/g) had larger absolute reductions in kidney disease progression.
“The findings suggest that guideline recommendations distinguishing between patients based on diabetes status or albuminuria level may no longer be necessary,” Staplin said. “Current international kidney disease guidelines give stronger recommendations for using SGLT2 inhibitors in patients with high albumin levels, but the new results indicate that all patients with chronic kidney disease can benefit.”
Abstract No. FR-OR086
In the multicenter, randomized OPTIMIZE trial, Stefan P. Berger, Ph.D., of the Universitair Medisch Centrum Groningen in the Netherlands, and colleagues found that a reduced-dose immunosuppressive regimen combining low-dose tacrolimus plus everolimus is safe among older kidney transplant recipients (age 65 years and older), but the regimen does not lead to improved outcomes compared with the current standard regimen.
The authors investigated whether older kidney transplant recipients could benefit from a reduced and less nephrotoxic immunosuppressive regimen. Three hundred seventy-nine kidney transplant recipients aged 65 years or older, across six Dutch university medical centers and the University Hospitals Leuven, were included in the study. The study compared a “standard” immunosuppressive regimen (prednisolone + standard-dose tacrolimus + mycophenolate mofetil) versus an “adapted” regimen (prednisolone + low-dose tacrolimus + everolimus).
The primary outcome was defined as a “successful transplantation” at two years: patient alive with functioning graft and minimum estimated glomerular filtration rate thresholds (≥30 mL/min/1.73m2 for older deceased-donor kidneys; ≥45 mL/min/1.73m2 for younger deceased donor or living donor kidneys).
At two years, the authors observed no statistically significant difference between arms — 50 percent success in the low-dose arm versus 57 percent in the standard-dose arm.
“Importantly, the adapted regimen was safe, but it did not demonstrate superiority over the standard regimen in this older population,” Berger said. “Clinicians should be reassured that older transplant recipients achieve very good outcomes under current standard regimens (89 percent patient survival; only 5 to 6 percent graft loss at two years) and that a reduced regimen is safe. We should move toward stratified immunosuppression in older patients with an awareness that immunosuppression can be reduced safely in most cases. Clearly the OPTIMIZE trial had not hit the threshold for reduction of immunosuppression. The study highlights the need for further research to tailor the immunosuppressive regimen to the individual older patient (taking into account donor age, immunosenescence, comorbidities, frailty, etc.).”
The study was funded by Chiesi Pharmaceuticals.
Abstract No. FR-OR085
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