ISN Global Trials Focus: December 2019
ISN Academy. ISN-ACT . 12/13/19; 287140 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? Click on the Discussion Forum button above and start interacting!

This month, we reviewed the following trials:
- No change in vascular calcification scores with rivaroxaban or vitamin K in hemodialysis patients
Multicenter Randomized Controlled Trial of Vitamin K Antagonist Replacement by Rivaroxaban with or without Vitamin K2 in Hemodialysis Patients with Atrial Fibrillation: the Valkyrie Study
De Vriese et al. J Am Soc Nephrol. 2019 Nov 8. pii: ASN.2019060579

- Dumbbell exercise improves AVF blood flow in hemodialysis recipients
Effect of dumbbell exercise on arteriovenous fistula in patients undergoing maintenance haemodialysis: a prospective randomized controlled trial
Mo et al. Blood Purif. 2019. Sep 19:1-9. DOI: 10.1159/000502332

- No effect on muscle function or bone mineral density from sodium bicarbonate therapy in those with low-normal bicarbonate levels
Effects of sodium bicarbonate in CKD Stages 3 and 4: A randomized, placebo-controlled, multicentre clinical trial
Melamed et al. Am J Kidney Dis. 2019 Nov 5. pii: S0272-6386(19)30945-X

- Tidal PD may be a safer alternative to intermittent PD in acute-start APD
Low-Volume Tidal Peritoneal Dialysis Is a Preferable Mode in Patients Initiating Urgent-Start Automated Peritoneal Dialysis: A Randomized, Open-Label, Prospective Control Study
Xie et al. Ther Apher Dial. 2019 Oct;23(5):409-417

- Twice-Daily vs. Once-Daily Tacrolimus in Low Risk Filipino Transplant Recipients
Pilot study comparing the efficacy, safety, convertibility and tacrolimus trough levels of twice-daily tacrolimus (Profgraf) to Once-Daily tacrolimus (Advagraf) among standard-risk kidney transplant patients at the National Kidney and Transplant Institute
Danguilan et al. Transplant Proc. 2019;51(8):2615-2619

- Bleselumab, a novel CD-40 antibody, well tolerated in Phase 2 study in kidney transplantation
Efficacy and safety of bleselumab in kidney transplant recipients: A phase 2, randomized, open‐label, noninferiority study
Harland et al. Am J Transplant. 2019 Sep 11. doi: 10.1111/ajt.15591

- No demonstrable renal benefit to supplementation of vitamin D and fatty acids in an American adult diabetic population
Effect of Vitamin D and Omega-3 Fatty Acid Supplementation on Kidney Function in Patients With Type 2 Diabetes: A Randomised Clinical Trial
De Boer et al. JAMA. 2019;322(19):1899-1909

- Novel inhibitor slows vascular calcification in patients receiving hemodialysis
Slowing Progression of Cardiovascular Calcification with SNF472 in Patients on Hemodialysis: Results of a Randomized, Phase 2b Study
Raggi et al. Circulation. 2019 Nov 11. doi: 10.1161/CIRCULATIONAHA.119.044195

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