The University Medical Center Groningen (UMCG) will start a new study in October into a medicine for people with severe kidney damage. This is done with the support of the Kidney Foundation. “This is groundbreaking research,” says Ron Gansevoort, professor of internal medicine at the UMCG and research leader of the Renal Lifecycle study. “We know that the drug works in patients with impaired renal function. We are going to see for the first time whether it also works in patients with severely impaired kidney function.” The results are expected in four years.
The drugs under study are so-called SGLT2 inhibitors. This is a new class of drugs that originally came on the market for people with diabetes to lower blood sugar levels. Gansevoort: “It was discovered by accident that the drugs work well for people with kidney and heart problems, even if they don’t have diabetes. The results from several studies are spectacular: the decline in kidney function is slowed down and sometimes stops altogether. There are also fewer hospital admissions for heart failure and fewer people die.”
Less pressure on kidney filters
The new drug works on the sugar balance of the kidney. “Because of the SGLT2 inhibitor you lose some sugar through the urine, and as a result you also lose some water and salt. This triggers a complex mechanism in the kidneys that reduces the pressure on the kidney filters. The kidney filters have to work less hard and therefore last longer,” explains Gansevoort.
These drugs have been shown to work in kidney patients with a reasonably good kidney function. The Renal Lifecycle study now examines for the first time how the drug works in people with kidney function of 25 percent or less. People who are on dialysis or who have had a kidney transplant are also included in the study. “The fact that the effect of the drug is being investigated simultaneously in different groups of patients is special for a clinical study,” says Wouter Eijgelaar, manager of Care & Innovation at the Kidney Foundation. “We therefore call it the Renal Lifecycle Study, because we want to know what the drug does in all ‘life stages’ of a kidney patient. From kidney damage that progresses to the point where the kidney fails and you have to dialysis and get a kidney transplant.”
Complications in renal failure
It concerns the patient groups where the need is greatest, Eijgelaar outlines. “If your kidneys fail, you have to go to the hospital for dialysis three times a week. Or you get a kidney transplant and have to take a lot of medicines to keep the transplanted kidney. That’s still not an easy life. There is also the complication of cardiovascular disease, which you have a greatly increased risk of as a kidney patient. And if you’re unlucky, the transplanted organ will fail and you’ll have to go back to dialysis. If the new drug even works, it will have a huge impact for all these people.”
The fact that the Kidney Foundation works together with the UMCG is possible thanks to a historically large gift from the Piet Poortman Fund, which the Kidney Foundation received last year. In total, the Kidney Foundation will use 3.3 million euros of the gift to finance the Renal Lifecycle study. Never before has the Kidney Foundation invested such a large amount of money in a clinical study.
“We want to make history with research that is not funded by the pharmaceutical industry,” says Gansevoort. “Pharmaceutical companies didn’t want to fund it because the drug’s patents expire in a few years. They can no longer earn that much.” The research is also catching on outside the national borders. “Hospitals from Australia, Belgium and Germany join spontaneously and bring their own money. We also consult with a number of US hospitals. It shows how important this research is.”
Better treatment and healthier life
The dream outcome for kidney patients is that the research shows that the drug stops the decline in kidney function and prevents heart failure and death. Gansevoort: “If that happens, people will no longer turn to dialysis and transplantation. People with a donor kidney will also live longer and healthier. So the hope is that we can improve treatment in people with severe kidney damage.”
Whatever the results in four years; the investigation is useful in all cases. “If the drug does not work or does not work sufficiently, then it is clear that we should not prescribe it to people with severe kidney damage. If it does work, it will be one of the biggest positive changes in the treatment of kidney patients in the last 20 years.”
Participate in the research
The Renal Lifecycle study requires the cooperation of approximately fifteen hundred people with severe kidney damage. “If people participate, the burden on them is very limited,” says research leader Ron Gansevoort of the UMCG. “They take the drug or a placebo and donate blood and urine a few times a year. This happens at times when patients are already in the hospital for a regular visit.” The side effects of the drug are limited. “There is an increased risk of a bladder infection, but it is usually mild and treatable.”
People who want to participate can report to their own nephrologist. Almost all hospitals and dialysis centers that receive kidney patients participate. The research is also monitored by a group of kidney patients from the Kidney Patients Association. They ensure that the research and the way in which participants are informed is carried out in an appropriate manner. Also visit www.renal-lifecycle.com for more information about this research.
Webinar
On October 8, Ron Gansevoort will tell more about the research during the Science Day. For more information, visit www.nieren.nl.