An open label, Phase II dose escalation and expansion study to evaluate the safety and efficacy of propagermanium (PPG) added to stable angiotensin receptor blocker therapy (irbesartan) for the treatment of patients with proteinuria

Dimerix Bioscience Pty Ltd0 个研究点目标入组 27 人开始时间: 2014年10月23日最近更新: 2020年1月13日

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•Capable of providing informed consent.
•Women of child bearing potential or men of reproductive potential must be using adequate birth control measures.
•Previously diagnosed with protein in the urine and have a protein/creatinine ratio (PCR) of greater than 50 (mg/mmol) based on 24 hour urine collection.
•Patients with a defined level of kidney function as follows:
•- serum creatinine 115 to 291 micromol/L inclusive for women
•- serum creatinine 132 to 309 micromol/L inclusive for men
•- or estimated GFR 20-60
•Taking stable irbesartan with BP in range of 110/70 to 150/95 mmHg. (Stable is defined as taking the same dose of IRB for at least 90 days prior to baseline).
•Liver function tests less than or equal to 2X upper limit of normal
•Patients taking a diuretic must be on a stable dose for at least 2 months.

•Rapidly progressing proteinuria (rapidly progressing is defined as a trebling of proteinuria over the preceding 3 month period)
•Recent gastrointestinal bleeding
•Heart disease that is not considered stable
•Acute kidney injury within the 3 months before screening
•Are receiving any ACE inhibitor, NSAID therapy or spironolactone
•Have uncontrolled blood pressure
•Required to take drugs that change the immune system (immunosupressants)
•HIV infection
•Viral Hepatitis B or C, liver infection, liver cirrhosis or any clinically significant liver damage. (Liver function tests > 2X ULN)
•Cancer within 3 years (excluding non melanoma skin cancer) or high risk of developing cancer
•Major surgery within 3 months of screening or planned during the study period.

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