ERA-EDTA Congress 2011: Late Breaking Clinical Trials I

PRAGUE, Czech Republic, June 24, 2011 -

- RAVE study: In ANCA-associated vasculitis rituximab is just as
effective and safe as standard therapy

The randomised, double-blind, placebo-controlled multi-centre
study (abstract no. 2511) investigated the efficacy and safety of
the monoclonal antibody rituximab (RTX) in 197 ANCA-associated
vasculitis (AAV) patients. This study showed that in patients with
severe AAV a single course of rituximab for remission induction and
maintenance over a period of 18 months proved to be as effective as
standard therapy.

Hemodiafiltration reduces mortality only if high substitution
volumes are used

The prospective, randomised CONTRAST study (abstract no. 2507)
aimed to evaluate whether treatment with HDF reduces overall
mortality compared with low-flux HD. In the outcome there was no
difference between the two groups regarding the incidence of
overall mortality, but a subgroup analysis indicated that patients
who had reached a substitution volume of over 20 litres/treatment
had a significantly lower mortality risk than patients with lower
substitution volumes (HR 0.66; p = 0.03).

The prospective, randomised, controlled TURKISH HDF study
(abstract no. 2506) compared HDF with large pore hemodialysis (HD)
in terms of morbidity and mortality. The difference in terms of
mortality was not significant (p = 0.28), but a subgroup analysis
showed that HDF patients with a high substitution volume of >
17.4 litres/treatment had a significantly better cardiovascular and
overall survival rate.

Bardoxolone improves renal function in type II diabetics with
nephropathy

A double-blind, placebo-controlled multi-centre phase II study
(abstract no. 2501) randomized 227 type II diabetics with moderate
to severe CKD (eGFR 20-45 ml/min/1.73m?) in four different
groups.

Significant improvements in GFR were reported in all the
bardoxolone groups compared to the placebo group (p<0.001).
Other renal function parameters (creatinine and urea) were also
better in the Bardoxolone group.

For further information, please see:

www.eraedta2011.org/press.html

Bettina Albers
+49-3643776423
albers@albersconcept.de

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