Clinical Trial 48205

Miami, FL 33122


Summary:

Premier Clinical Research Institute is currently conducting a clinical research study evaluating the safety and efficacy of an investigational medication for patients with Diabetic Nephropathy (DN), Focal Segmental Glomerulosclerosis (FSGS), or Treatment-Resistant Minimal Change Disease (TR-MCD).

 Currently, there are no approved therapies in the US to specifically treat FSGS or TR-MCD. Despite current treatments for DN, patients continue to experience progressive loss of kidney function. Given this there is a need to develop new therapies to treat patients with DN, FSGS, and TR-MCD. Researchers hope that GFB-887 will slow or halt progression of kidney failure by inhibiting a target called TRPC5. TRPC5 is believed to play a role in in the progression of kidney diseases like DN, FSGS and TR-MCD. 

What is new in diabetic nephropathy?

Diabetic nephropathy is a serious complication of type 1 diabetes and type 2 diabetes. It's also called diabetic kidney disease. Diabetic nephropathy affects the kidneys' ability to do their usual work of removing waste products and extra fluid from your body. Over many years, the condition slowly damages your kidneys' delicate filtering system. Kidney disease may progress to kidney failure, also called end-stage kidney disease. Kidney failure is a life-threatening condition. At this stage, treatment options are dialysis or a kidney transplant.

In the early stages of diabetic nephropathy, you would most likely not notice any signs or symptoms. In later stages, signs and symptoms may include:

  • Worsening blood pressure control 
  • Protein in the urine
  • Swelling of feet, ankles, hands or eyes
  • Increased need to urinate
  • Reduced need for insulin or diabetes medicine
  • Confusion or difficulty concentrating
  • Shortness of breath
  • Loss of appetite
  • Nausea and vomiting
  • Persistent itching
  • Fatigue



Qualified Participants Must:
  • Male or female ages 18 to 75 years of age
  • Have diagnosis of Diabetic Nephrology, FSGC /TR-MCD (Focal Segmental Glomerulosclerosis/Treatment Resistant Minimal Change Disease)
  • eGFR > 30 mL/min
  • Currently receiving an ACE inhibitor ( Lisinopril, Enalapril, and Benazepril, etc.) OR ARB (Irbersartan, Losartan, Valsartan, etc.)
  • Cannot be on both, an ACE Inhibitor AND ARB 


Qualified Participants May Receive:

  • All study related exams and lab work 

  • Investigational study medication at no cost 

  • Complimentary transportation 

  • No insurance necessary  

  • Compensation for time and travel, if qualified 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.