News Release 

Late breaking clinical trial data at ISN World Congress of Nephrology

3 internationally significant presentations will impact kidney disease treatment

Tania Ewing and Associates

Melbourne, April 15, 2019 - Three internationally significant presentations at the World Congress of Nephrology today (April 15) will reveal new and highly relevant clinical data that may alter the treatment of kidney disease globally. The sessions (from 8:30 to 10:30 AEST time, Melbourne) will be live streamed by the International Society of Nephrology. To date more than 1000 people have registered to hear the results live streamed globally. Register free for live stream HERE.

The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Trial

The CREDENCE clinical trial, which was led by The George Institute for Global Health in Sydney, Australia, is to be presented by a team including Professor Vlado Perkovic and Associate Professor Meg Jardine from The George Institute, and Professor Ken Mahaffey from Stanford University, in the United States. It recruited over 4400 people from 34 countries with type 2 diabetes and established kidney disease, and found the drug, Canagliflozin, used to control blood sugar levels in people with diabetes, led to an approximately one third reduction in end stage kidney disease and death from renal causes.

The trial was stopped early - in July 2018 - because it was already clear that it was efficacious. It is considered to be the first new therapy in more than 15 years for slowing the progression of chronic kidney disease in patients with type 2 diabetes, and is available for use now. Worldwide, 160 million patients with type 2 diabetes are at risk for developing chronic kidney disease. The trial data will be published in the New England Journal of Medicine to coincide with the presentation at the WCN.

The Clinical Trial of IntensiVE (ACTIVE) Dialysis Study

To be presented by Dr Brendan Smyth, of The George Institute for Global Health in Sydney, Australia, the Clinical Trial of IntensiVE (ACTIVE) Dialysis Study reports on the long-term outcomes of a study to see whether intensive dialysis of 24 hours per week or more would improve the health and quality of life for people with end stage kidney disease.

The ACTIVE Dialysis Study was instigated by Professor Vlado Perkovic and Associate Professor Meg Jardine of The George Institute for Global Health in Sydney, Australia, and involved 200 participants from four countries (China, Australia, New Zealand and Canada) who were randomised to receive either 24 hours or 12 hours of dialysis per week for 12 months. At the end of that period there were no difference in overall quality of life although there were small but potentially important improvements in some quality of life domains. Dr Smyth will present on the subsequent outcomes and dialysis preferences for these participants since the trial concluded.

The Study of Diabetic Nephropathy with Atrasentan (SONAR) trial

Data from the SONAR trial will be presented by Professor Dick de Zeeuw, from the University of Groningen in The Netherlands and colleagues. SONAR is designed to determine if treatment with the investigational medicine atrasentan, when added to guideline-recommended standard-of-care therapies, was safe and could improve prognosis by delaying the onset of progression or end stage renal disease in type 2 diabetic patients at high risk for losing kidney function. Of the more than 11,000 patients with stage 2-4 chronic kidney disease who were initially screened for the trial, more than 4,700 patients completed a six-week "enrichment period" to gauge their response to a daily dose of atrasentan. Following the enrichment period, 2,648 patients responded to treatment and met the pre-defined criteria to continue on to randomization to treatment with atrasentan added to the standard-of-care or placebo added to the standard-of-care. An additional 1,020 patients who did not respond initially to treatment during the enrichment period were also randomized to treatment with atrasentan or placebo plus the standard-of-care. A median follow-up of 2.2 years among the patients who responded to atrasentan during the enrichment period demonstrated that treatment with atrasentan plus the standard-of-care reduced the rate of the primary renal endpoint by 35 percent, compared to placebo.

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Media contact:

If you are interested in organising post-forum interviews, please contact Tania Ewing on or before Thursday 11 April:

Email: taniaewing@taniaewing.com
Mobile: +61 408 378 422

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