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150 hospitals around the world participate in the study, which will include up to 500 patients with IgA nephritis due to kidney disease. IgA nephritis is the most common single cause of severe chronic kidney failure and the need for dialysis, right after diabetes.
“It feels great to have come this far,” says Bengt Fellström, senior consultant at the Academic Hospital and senior professor of kidney medicine at Uppsala University.
IgA nephritis is characterized by so-called IgA antibodies that are produced in abnormally large amounts in the intestinal lining and are stored in the kidneys, where they cause harmful inflammation.
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IgA nephritis disease is one of the most common causes of kidney failure so severe that the patient must receive dialysis to purify the blood.
The new drug is a tablet preparation of a cortisone-like substance, budesonide, specially designed to act almost exclusively on the intestinal mucosa, where abnormally large amounts of IgA antibodies are produced.
“Our hypothesis when we developed this form of treatment was that by decreasing the abnormal production of IgA antibodies in the retina, it should also be possible to prevent harmful storage in the kidneys,” says Bengt Fellström.
Last year, a study of 150 patients showed that the treatment works as planned for at least nine months. In patients receiving the new drug, the amount of egg white in the urine decreased and kidney function stabilized, and in patients receiving placebo tablets, it continued to deteriorate.
Here you can read about the results of the previous study when it was published in The Lancet medical journal last year.
Bengt Fellström hopes that the new Phase III study will confirm these positive results, also in the long term.
– May lead to treatment being registered as medicine and available to more kidney patients. In addition to increasing quality of life, it may mean that patients with IgA nephritis do not have dialysis or a kidney transplant, he says.
The drug, which was called Nefecon, is manufactured by Stockholm-based company Calliditas Therapeutics.
Here you can read an interview with a patient with IgA nephritis.
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