High-impact clinical trials yield results that could improve kidney care
The results of numerous high-impact clinical trials that could affect kidney-related medical care will be presented at ASN Kidney Week 2015, November 3-8 at the San Diego Convention Center in San Diego, CA.
- An 820-participant randomized trial found that high doses of statins do not reduce the risk of acute kidney injury (AKI) following heart surgery in patients with chronic kidney disease, and they may actually increase risk in patients who have never received the drugs. But continuing regular statin treatment or withdrawing it short-term does not affect AKI risk. "Statins reduce cholesterol but also affect several mechanisms underlying AKI, a common and debilitating complication after cardiac surgery," said lead author Frederic Tremaine Billings, MD.
High Dose Perioperative Atorvastatin and Acute Kidney Injury Following Cardiac Surgery
- In a randomized trial of 7286 high-risk patients undergoing heart surgery with cardiopulmonary bypass, methylprednisolone, a corticosteroid, did not alter the risk of AKI. "Results were consistent with multiple alternate continuous and categorical definitions of acute kidney injury, and in the subgroup with baseline chronic kidney disease," the authors noted.
Effect of Methylprednisolone on Acute Kidney Injury in Patients Undergoing Cardiac Surgery with Cardiopulmonary Bypass
- A randomized study of 567 hemodialysis patients found that omega-3 polyunsaturated fatty acids does not reduce failure of an arteriovenous fistula, which is created by connecting a patient's own vein and artery to form a long-lasting site through which blood can be removed and returned. It was hoped that omega-3 polyunsaturated fatty acids might prevent complications by inhibiting platelet aggregation, blood vessel constriction, and inflammation.
The Omega-3 fatty acids (Fish oils) and Aspirin in Vascular Access Outcomes in Renal Disease (FAVOURED) study: a randomised placebo-controlled trial
- In a randomized trial of 373 patients on dialysis, nalbuphine, a type of drug called a κ-opioidagonist/μ-opioid antagonist, was safe and reduced itching intensity. Other quality of life measures, such as sleep, also seemed to improve. "Patients on dialysis often develop a highly bothersome, relentless itching condition called uremic pruritus that goes on for years and adversely affects sleep, mood, and desire to be with others," said lead author Vandana Mathur, MD, FASN. "We plan to continue our development work in uremic pruritus, and are also studying this promising drug in prurigo nodularis, a disease characterized by itchy skin eruptions. Ultimately, we hope, to gain regulatory approvals to make the drug available to patients who need it."
Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients with Uremic Pruritus
- In a randomized trial of 90 kidney transplant recipients, the osteoporosis drug denosumab effectively increased bone mineral density, but it was associated with more frequent episodes of urinary tract infection and slight decreases in blood calcium levels. "Kidney transplant recipients suffer a decrease of bone mineralization in the first year after transplantation and are prone to develop osteoporosis," said lead author Rudolf Wüthrich, MD, FASN. "Future studies will need to examine whether a prolonged treatment with denosumab can reduce the risk of fractures."
Prevention of Bone Mineral Density Loss in De Novo Kidney Transplant Recipients with Twice-Yearly Denosumab: A Randomized Controlled Trial