Clareo Health | A Study of AST-120 for Evaluating Prevention of Progression In Chronic Kidney Disease Including Assessment of Quality of Life (EPPIC-2)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tanabe Pharma Corporation
With
Kureha Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 years or older
Moderate to severe CKD, not anticipated to require dialysis or renal transplant within the next 6 months
Patient survival expected to be no less than one year
Serum creatinine in men \>= 2.0 mg/dL (\>= 177 µmol/L) and \<= 5.0 mg/dL (\<= 442 µmol/L), and in women \>= 1.5 mg/dL (\>= 133 µmol/L) and \<= 5.0 mg/dL (\<= 442 µmol/L) at Screening
Urinary total protein to urinary total creatinine ratio must be \>= 0.5 on a spot void obtained at Screening
Blood pressure \<= 160/90 mmHg at both Screening and Baseline visits. In addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to Screening, with no more than 1 blood pressure reading \> 160/90 mmHg
In patients being treated for hypertension, they should be on a stable anti-hypertensive regimen
You may not be if
Obstructive or reversible cause of kidney disease
Nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine of \> 6.0 as measured on a spot void
Adult polycystic kidney disease
History of previous kidney transplant
History of recent (within the past 6 months) accelerated or malignant hypertension
Uncontrolled arrhythmia or severe cardiac disease within the past 6 months
History of malabsorption, inflammatory bowel disease, hiatal hernia, active peptic ulcer, or severe GI dysmotility, not attributable to the use of a phosphate binder
Received any investigational agent or participated in a clinical study within the previous 3 months
Presence of any significant medical condition that might create an undue risk with study participation, or significantly confound the collection of safety and efficacy data in this study
