This morning, SynAct Pharma AB announced in a press release that they began a Phase II clinical trial to determine the efficacy and safety of AP1189 on treating patients with idiopathic membranous nephropathy (iMN) and nephrotic syndrome (NS).
Membranous nephropathy (MN) is a kidney disorder in which glomeruli, or small blood vessels, become inflamed and thickened. Normally, glomeruli help filter waste from the blood. But when they are damaged, proteins leak into the urine, causing symptoms of nephrotic syndrome.
Idiopathic means that a condition occurred spontaneously or from an unknown cause. So idiopathic membranous nephropathy refers to the fact that doctors aren’t really sure what causes it. However, some potential causes include autoimmune disorders, infections, medication usage, cancer, or other kidney diseases.
Symptoms of membranous nephropathy include:
- Foamy urine
- High cholesterol
- Weight gain
- Swelling, particularly in the legs and ankles
- Proteinuria, or increased protein in the urine
- Increased levels of fat in the blood
- Needing to urinate more
Learn more about membranous nephropathy.
Idiopathic membranous nephropathy is one of the leading causes of nephrotic syndrome in adult patients. According to the American Kidney Fund, nephrotic syndrome:
is a group of symptoms that show your kidneys are not working as well as they should. These symptoms include too much protein in your urine, not enough protein in your blood, too much fat or cholesterol in your blood, and swelling.
Nephrotic syndrome is more common in males than females. If it occurs in children, symptoms usually develop between the ages of 2 and 6.
The Phase II study for AP1189 will be double-blind, multi-center, and placebo-controlled. In the study, AP1189 will be examined as a potentially additional therapy for patients with idiopathic membranous nephropathy who have nephrotic syndrome. Currently, first treatments for patients with iMN are Angiotensin II receptor blockers or Angiotensin-converting-enzyme inhibitors. In this case, patients will receive 1 dose daily (100mg AP1189) OR a placebo for a 1 month period. Researchers seek to understand how this treatment impacts proteinuria, or protein levels in the urine.