EDTA CONGRESS NEWSLETTER | June, 26 | Late Breaking Clinical Trials
Late breaking clinical trials: Results
The 47th ERA-EDTA/DGfN congress in Munich has been the setting for a wide range of new clinical data. The results of the following clinical trials were presented at "Late-Breaking Clinical Trials, Session I".
Prof. Rudolf P. Wüthrich and PD Dr. Andreas Serra (Zürich, Switzerland)
This single-center, randomized controlled, open-label trial conducted at University Hospital Zurich assesses the therapeutic effect, safety and tolerability of the mTOR inhibitor sirolimus in about 100 ADPKD patients. The primary outcome was the inhibition of kidney volume growth measured by blinded magnetic resonance imaging (MRI) volumetry.
In adult ADPKD-patients with CKD stage 1 and 2 and progressive disease, sirolimus did not slow polycystic kidney growth. It had no effect on GFR, and a small increase in albuminuria was observed. The adherence in the study was excellent and the medication was relatively well tolerated and safe.
Prof. Gerd Walz (Freiburg, Germany)
The primary objective of this placebo-controlled study was to demonstrate that everolimus has superior efficacy compared to placebo in reducing the mean total kidney volume from baseline to 24 month of treatment in patients with ADPKD, and whether the administration of 5 mg/day everolimus is safe and well tolerated. About 400 patients were enrolled. The primary endpoint was the mean total kidney volume as determined by magnetic resonance imaging.
The study showed that cyst growth progressed more slowly under everolimus than under placebo. At month 12 the difference was even significant, but the difference did not gain statistical significance at month 24 - probably due to the large number of drop-outs because of side-effects. However, slower cyst growth had no impact on GFR. In the everolimus arm, GFR was even lower than in the placebo group.