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Last updated on April 20, 2014 at 8:04 EDT

ERA-EDTA CONGRESS 2013: Late Breaking Clinical Trials

May 21, 2013

ISTANBUL, May 21, 2013 /PRNewswire/ –

The congress of the ERA-EDTA (European Renal Association – European Dialysis and
Transplant Association) is the biggest congress in Europe on nephrology and renal
replacement therapy. Nearly 10,000 participants are in Istanbul to share their knowledge
and discuss the latest research findings. New pioneering studies have been presented:

/ (1) Gupta, A et al. “SOLUBLE FERRIC PYROPHOSPHATE (SFP) ADMINISTERED VIA
HEMODIALYSATE REDUCES ESA USE”

By SFP-iron administration, the ESA dose could be reduced by 35% while maintaining
stable Hb levels. There were no SFP-related adverse effects and no cases of iron overload.

(2) Van Eps, C. “THE EFFECTS OF TOPICAL ANTIBACTERIAL HONEY ON CATHETER-RELATED
INFECTIONS IN PERITONEAL DIALYSISPATIENTS ”

The honey-containing wound gel was not superior to mupirocin application for the
prophylaxis of PD catheter-associated infections.

(3) Striker, GE et al. “RESTORATION OF REPRESSED ESTROGEN RECEPTOR alpha (ERalpha) AND
ANTI-OXIDANT LEVELS IN WOMEN AND MEN WITHDIABETIC KIDNEY DISEASE (DKD): POSSIBLE
CARDIOVASCULAR DISEASE (CVD) BENEFITS”

In response to treatment with Sevelamer there was significant upregulation of
oestrogen receptor alpha (ERalpha); the known effect of this is a reduction of oxidative
stress and inflammation. As a consequence, inflammatory markers and antioxidant levels
also improved during treatment.

(4) Marz, W et al. “PROGNOSTIC EFFECT OF HIGH DENSITY LIPOPROTEIN CHOLESTEROL AND
APOLIPOPROTEINS A1, A2, AND C3 INDIABETIC PATIENTS ON HEMODIALYSIS”

The results revealed no association between HDL, apolipoprotein A1 and C3
concentrations and cardiovascular events. In contrast, high apolipoprotein A2
concentrations were associated with a lower cardiovascular risk and might possibly be as
outcome marker.

(5) Silbernagel, G et al. “CHOLESTEROL ABSORPTION PREDICTS THE EFFECTIVENESS OF
ATORVASTATIN FOR PREVENTING CARDIOVASCULARDISEASE IN HEMODIALYSIS PATIENTS”

High cholesterol absorption efficiency in a patient was predictive of the poor
effectiveness of atorvastatin therapy in terms of cardiovascular endpoints. Consequently,
measurement of cholesterol absorption might identify those dialysis patients who would
benefit from statin therapy.

(6) De Zeeuw, D et al. “THE SELECTIVE TYPE A ENDOTHELIN ANTAGONIST ATRASENTAN REDUCES
RESIDUAL ALBUMINURIA IN PATIENTS WITH TYPE 2 DIABETES AND NEPHROPATHY”

A greater than 30% reduction in albuminuria was recorded in more than half the
patients treated with atrasentan. In addition, there were significant reductions in LDL
cholesterol as well as triglyceride levels in the active treatment groups. Atrasentan
might therefore be a highly promising new therapy, in addition to RAAS blockade, for
reducing albuminuria in diabetic patients.

(7) Cannata-Andia, JB et al. “THE USE OF PTH-LOWERING DRUGS IS ASSOCIATED WITH
IMPROVED SURVIVAL IN HEMODIALYSIS PATIENTS: RESULTS FROM COSMOS”

As part of the COSMOS study, a 3-year European multicentre observational study
conducted in 6273 HD patients, a prospective evaluation of the effect of PTH-lowering
products on patients’ outcome was performed: Patients benefited significantly from all
PTH-lowering treatments.

(8) Floege, J et al. “SAFETY AND EFFICACY OF PA21, A NOVEL IRON-BASED PHOSPHATE
BINDER, IN PATIENTS WITH ESRD AND HYPERPHOSPHATEMIA: LONG-TERM RESULTS”

This is a 28-week extension of a comparative study already presented in 2012 which had
demonstrated similar efficacy for the two phosphate binders. In the study extension the
phosphate-lowering effect of both treatments remained constant. In addition, it was shown
that the adverse effects in the PA21 group diminished over time (in terms of its adverse
effect profile, PA21 was inferior in the first study), with the two groups being
comparable at the end of the study.

(9) Floege, J et al. “EFFECT OF CINACALCET USE ON ALL-CAUSE MORTALITY: PARALLEL
ANALYSES IN ARO INCIDENT OBSERVATIONAL EUROPEAN HEMODIALYSIS POPULATION AND IN EVOLVE
TRIAL”

This analysis in a cohort of the prospective observational ARO study (the design of
the EVOLVE study was “reconstructed” in this analysis) showed a treatment effect
comparable to that in EVOLVE. The authors concluded that the results of the randomized
EVOLVE study can be transposed to a broader population.

(10) Wang, A et al. “ORAL PARICALCITOL TREATMENT ON LEFT VENTRICULAR MASS AND FUNCTION
IN CHRONIC KIDNEY DISEASE PATIENTS WITH CARDIAC HYPERTROPHY (OPERA STUDY): A RANDOMIZED
CONTROLLED TRIAL”

The study investigated the effect of oral paricalcitol on left-ventricular mass after
52 weeks of therapy. The result revealed no significant difference from placebo in terms
of left-ventricular mass index and also of the other cardiac endpoints. However, during
treatment there was a significant improvement in the biochemical parameters of CKD-MBD
(PTH and alkaline phosphatase).

Background information and the study abstracts can be downloaded:

http://www.era-edta2013.org/en-US/press

        Contact
        albersconcept
        Dr. Bettina Albers
        Jakobstrasse 38
        D-99423 Weimar
        E-Mail: press@era-edta.org
        Fon: +49-(0)36-43 / 77-64-23
        Mobile: +49-(0)174 / 21-65-629

SOURCE European Renal Association – European Dialysis and Transplant Association (ERA-EDTA)


Source: PR Newswire