Volume 30, Issue 12, December 2015

… limitations notwithstanding, the hypothesis that AV fistula may retard CKD progression has passed the first very large mesh filter of a low-power observational study. The next step is to test the same hypothesis in existing, very large clinical databases by adopting advanced statistical techniques and by performing all of the sensitivity analyses needed to ponder the credibility of the results of such analyses. Ultimately, we should never forget that there are no shortcuts in the assessment of the efficacy of interventions. A randomized clinical trial will eventually be needed to assess the causal nature of the link between arteriovenous fistula and the rate of GFR loss in CKD.…

…we have to keep in mind that we generally lack data from adequately powered clinical trials on the benefits and risks of i.v. iron supplementation in CKD. The rise and fall of ESAs taught us that any treatment strategy for anemia of CKD must be tested in adequately designed clinical trials which do not focus on surrogates such as changes in hemoglobin levels, but on clinical end-points. …

…though it is important to collect new data supporting the safety of PTX and suggesting a clinical advantage for PTX patients, a more definitive opinion could be reached only after a multi-center trial specifically directed to explore this issue. …