ERA-EDTA Congress 2011: Late Breaking Clinical Trials I

PRAGUE, Czech Republic, June 24, 2011 /PRNewswire/ --

- 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:

http://www.eraedta2011.org/press.html

Bettina Albers
+49-3643776423
albers@albersconcept.de