ST. PAUL, Minn., Nov. 6 (UPI) — Positive results from a late-stage clinical trial released Thursday have raised hopes that type 1 diabetes patients who suffer from chronic kidney disease will have a new treatment for the first time in decades.
The results of the Phase 3 trial, unveiled at American Society of Nephrology annual conference in Houston, found that the drug finerenone, made by pharma giant Bayer and marketed under the brand name Kerendia, is safe and effective in treating type 1 diabetics who also suffer from chronic kidney disease.
The study comes as the global burden of type 1 diabetes is increasing every year, carrying significant implications for public health systems worldwide.
It’s an autoimmune condition in which the body begins attacking insulin-producing cells in the pancreas silently and without warning. In its two earliest stages, the disease has no symptoms and is detectable only through blood screening for antibodies.
At stage 3, symptoms such as extreme hunger, unintended weight loss, fatigue and weakness, blurred vision and mood changes manifest themselves and insulin treatments become necessary.
Type 1 diabetes is distinct from type 2 diabetes, which is not an autoimmune condition and occurs when the body isn’t making enough insulin (as opposed to none with type 1), or what it does make isn’t working properly.
Kerendia, first introduced in 2020, already is being used to successfully treat kidney disease in type 2 diabetes, but treatment for type 1 was not approved.
What causes type 1 diabetes remains unknown, but its prevalence is rising quickly. Last year, the disease affected about 9 million people globally, including more than 1.5 million children — some 13% higher than 2021’s figure of 8.4 million, according to the International Diabetes Federation Atlas.
Last year alone, more than 500,000 new diagnoses were reported worldwide.
One frequent complication associated with type 1 diabetes is progressive decline in kidney function, especially among the growing number of patients who have survived into middle- and old age with the help of modern insulin therapy.
While not as common as in past decades, chronic kidney disease still affects 30% to 40% of type 1 diabetes patients, putting them at increased risk of kidney failure and cardiovascular disease.
Even though more than one-third of these patients develop kidney failure within 15 years of the onset of severe protein loss through the urine known as albuminuria, the treatment of kidney disorders among type 1 diabetes patients has remained unchanged in 30 years — until now, according to Bayer.
Results of the phase 3 clinical trial known as FINE-ONE showed a slowdown of albuminuria by one-fourth among 242 type-1 diabetes patients using Kerendia after six months, which will very likely to translate to less kidney failure in these patients, said Dr. Carolina Aldworth, the pharma company’s executive medical director.
“For people with type 1 diabetes and chronic kidney disease, treatment options have remained largely unchanged for over three decades, typically relying on ACE [angiotensin-converting enzyme] inhibitors or ARBs [angiotensin receptor blockers],” she told UPI in a statement.
“The FINE-ONE results show the potential of Kerendia to address this unmet medical need, building on the existing wealth of evidence for Kerendia in patients with type 2 diabetes and chronic kidney disease.”
The results were reported by the trial’s lead author, clinical pharmacology professor Hiddo Lambers Heerspink of the University of Groningen in The Netherlands. He told UPI before the Houston conference that the drug could provide a long-sought new treatment option for type 1 diabetics in dire need for better and more effective alternatives for kidney disease.
“These patients are now treated with blood pressure medication and insulin to optimize blood pressure and sugar control,” he said. “However, many patients remain at very high risk of kidney failure [requiring dialysis or kidney transplantation] and cardiovascular disease, experience a reduced quality of life and shortened life expectancy.”
While treatments for type 2 diabetes and kidney disease have improved recently, “patients with type 1 diabetes have been left behind and no new therapies have been discovered for more than 30 years,” Heerspink said.
“Patients’ physicians tell them that the treatments for type 2 diabetes and [chronic kidney disease] cannot be used in type 1 diabetes because the efficacy and safety of these drugs used for type 2 diabetes are not evaluated in rigorous clinical trials.”
That dynamic has now changed, he said, adding, “We are very glad that the primary clinical trial endpoint has been met, as finerenone is already available for clinical use and we hope to be able to implement these findings in clinical practice very soon.”
