ISN-ACT Global Trials Focus: September 2019
ISN Academy. ISN-ACT . 09/12/19; 282013; 6199 Topic: Global Nephrology
Disclosure(s)(s): The ISN-Advancing Clinical Trials is a new initiative of the ISN intended to leverage existing infrastructures within ISN, in order to improve global nephrology community participation in clinical trial research. As part of its activities, the ISN-ACT highlights and sometimes analyzes important recent nephrology trials from latest medical literature every month through the ISN-ACT Trial-list. Editors of the ISN-ACT Trial-List also select clinical trials of particular impact, and collaborate with the @ISNeducation social media learning team to represent these trials visually. Join the ISN-ACT To generate more high-quality clinical trials and studies in nephrology, ISN-ACT is calling on investigators and interested individuals. If you are an ISN member interested to join this great initiative, submit your application online. Use the button below (download PDF) to download this month's edition of the list.
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The ISN-ACT (Advancing Clinical Trials) team presents this monthly showcase of randomized trials in nephrology from around the world. The trials selected are not necessarily those likely to have the highest impact. Our aim is to showcase the diversity of trials recently published and to review these in context, assessing their risk of bias in seven key areas. We hope that our efforts will drive improvement in trial quality and promote greater engagement in trial activity.

Join the debate in the Discussion Forum: Will these trials affect your practice? Are the results valid? How could the trials have been improved? What further studies are needed?

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This month, we reviewed the following trials:

- Brachial plexus block superior to conscious sedation during endovascular treatment of fistulas
Comparison of Sedoanalgesia Versus Ultrasound-Guided Supraclavicular Brachial Plexus Block for the Prevention of the Pain During Endovascular Treatment of Dysfunctional Hemodialysis Fistulas
Gedikoglu, et al. Cardiovasc Intervent Radiol. 2019 Jul 24.

- Roxadustat holds its own in China, although long-term studies are still needed
Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis
Chen, et al. N Engl J Med. 2019 Jul 24

- Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis
Chen, et al. N Engl J Med. 2019 Jul 24

- Everolimus lowers incidence of CMV compared with mycophenolate in ECD Kidney transplants but this may be at the cost of more graft loss and acute rejection
Prospective randomized study comparing everolimus and mycophenolate sodium in de novo kidney transplant recipients from expanded criteria deceased donor
Ferreira, et al. Transpl Int. 2019 Jul 6.

- Iron based phosphate binders lower ESA dose requirements
Randomised clinical trial of ferric citrate hydrate on anaemia management in haemodialysis patients with hyperphosphataemia: ASTRIO study
Yokoyama, et al. Sci Rep. 2019; 9: 8877

- Is there a role for intra-dialytic exercise in those doing twice-weekly hemodialysis?
The effect of intradialytic exercise twice a week on the physical capacity, inflammation, and nutritional status of dialysis patients: A randomised controlled trial
Suhardjono, et al. Hemodial Int. 2019 May 17. doi: 10.1111/hdi.12764

- Esaxerenone – a novel mineralocorticoid receptor antagonist - reduces albuminuria in Type 2 DM
Effect and Safety of Esaxerenone (CS-3150) for the treatment of Type 2 Diabetes with Microalbuminuria
Ito, et al. Clin J Am Soc Nephrol. 2019;14(8):1161-1172

- No increased risk of wound-healing complications with immediate start everolimus post-transplant
A 3-month, multicenter, randomized, open-label study to evaluate the impact on wound healing of the early [vs. delayed] introduction of everolimus in de novo kidney transplant recipients, with a follow-up evaluation at 12 month after transplant (NEVERWOUND study).
Manzia et al. Transplantation. 2019 Jun 26. doi: 10.1097/TP.0000000000002851

- Nifedipine may be superior for the acute management of severe hypertension in pregnancy
Oral antihypertensive regimens (nifedipine retard, labetalol, and methyldopa) for management of severe hypertension in pregnancy: an open-label, randomised controlled trial
Easterling et al. Lancet. 2019 Aug 1. pii: S0140-6736(19)31282-6

- Cefepime monotherapy an effective strategy to manage CAPD peritonitis
Intraperitoneal Cefepime Monotherapy Versus Combination Therapy of Cefazolin Plus Ceftazidime for Empirical Treatment of CAPD-Associated Peritonitis: A Multicenter, Open-Label, Noninferiority, Randomized, Controlled Trial.
Kitrungphaiboon et al. Am J Kidney Dis. 2019 Jul 19. doi: 10.1053/j.ajkd.2019.05.011.
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