MELBOURNE, Australia — A dialysis regimen that extends weekly hours does not prolong the life of the patient but it could lead to other benefits, long-term trial data suggest.
"Unfortunately, our study was not large enough to provide conclusive evidence that longer dialysis hours affect mortality," said Brendan Smyth, MBBS, a PhD candidate at the George Institute for Global Health in Sydney, Australia.
But "we know longer hours improve blood pressure and reduce medication burden. For some patients, those things might be a priority and they can go ahead and push for longer dialysis hours. It certainly does not appear harmful," he told Medscape Medical News.
"I think this reinforces the importance of individualizing your dialysis treatment," he added.
Smyth presented findings from the ACTIVE trial (NCT00649298) during a late-breaking clinical trials session here at the International Society of Nephrology (ISN): 2019 World Congress.
He and his colleagues randomized adults from four countries — Australia, Canada, China, and New Zealand — to extended dialysis (a median of 24 hours a week) or standard dialysis (a median of 12 hours a week) for 12 months.
During the subsequent 48-month follow-up period, the majority of participants in both groups adhered to standard hours, so all but a few patients were undergoing dialysis for a median of 12 hours a week.
At 60 months, survival was similar in the extended and standard groups (P = .79).
The results "weren't that amazing," said study coauthor Meg Jardine, MBBS, PhD, also from the George Institute for Global Health.
|Table. Number of Patients Undergoing Dialysis for More Than 24 Hours a Week|
|Time Point||Extended Group, n||Standard Group, n|
"I think initially there was surprise from the nephrology community that we didn't see profound benefit," Jardine told Medscape Medical News. "There's no magic bullet here, but we did see changes in things important to some people, such as lowering the number of medications they have to take, better blood pressure and phosphate control, and some particular quality-of-life domains. For me, that's a more sensible and reliable piece of evidence."
During the follow-up period, 31 participants underwent kidney transplantation — 17 in the extended group and 14 in the standard group — and 38 died — 18 in the extended group and 20 in the standard group.
The number of participants undergoing dialysis for at least 24 hours a week was low overall and decreased as the years passed. The small size of the study is an "obvious" limitation, even though ACTIVE is the largest study of extended-hours dialysis to date, Smyth said.
"The long-term follow-up was never powered to detect a mortality difference, other than an implausibly large one," he said.
Overall survival was 80% at 60 months, "which is very good for dialysis patients in general," Smyth said. However, he acknowledged, the average age of the participants was 51.8 years, so the study cohort was likely younger and healthier than a typical population of patients on dialysis.
Institutional factors, such as the ability to provide extended hours for dialysis, affect a center's ability to perform this type of research on patient groups, he pointed out.
"It's not that patients don't tolerate" extended-hours dialysis, he said, "but it's a complex intervention. That makes bigger or longer studies challenging. I would not want these results to discourage people already doing extended-hours dialysis and feeling they're doing well."
The trial results elicited both dismay and a call to dig deeper.
"On the face of it, the results are disappointing, but there are a lot of caveats," said Peter Kerr, PhD, from Monash Medical Centre in Clayton, Australia, who is chair of the World Congress of Nephrology (WCN) local organizing committee.
"It's hard to know what to make of it," he told Medscape Medical News. Much of the extended-hours dialysis in the trial was administered at satellite centers instead of patients' homes, he said.
"If that makes a difference, it's hard to know. It's not going to stop me doing it," he added. "If you talk to patients on extended hours, they would never go back. Patients feel their whole wellbeing is better."
Extended-hours dialysis "is not that much more" than standard treatment, said Adeera Levin, MD, from University of British Columbia in Vancouver, Canada, who is a past president of ISN.
In fact, patients who undergo nocturnal dialysis can reach 36 hours each week, she pointed out.
"People need to know what extended dialysis means in this context and to be careful not to extrapolate that no one could benefit from more dialysis," Levin told Medscape Medical News. "As a clinician, and after observing people on nocturnal dialysis, which is much more than 18 hours, the benefits appear to be profound in patients who can tolerate nocturnal."
This study was partially funded by Baxter. Smyth has received sponsored travel from Roche Australia. Jardine has received research support from Gambro, Baxter, CSL, Amgen, Eli Lilly, and MSD; served on advisory boards for Akebia, Baxter, Boehringer Ingelheim, CSL, and Vifor; served on a steering committee for a trial sponsored by Janssen; and spoken at scientific meetings sponsored by Janssen, Amge, and Roche. Kerr is a member of the advisory board for Bayer. Levin is an advisor to Janssen.
International Society of Nephrology (ISN): 2019 World Congress: Abstract O-352 Presented April 15, 2019.
Medscape Medical News © 2019
Cite this: Lengthier Dialysis Doesn't Translate to Longer Life - Medscape - Apr 16, 2019.