This is a phase 2a study evaluating the safety and tolerability of multiple ascending doses of GFB-887 in patients with diabetic nephropathy (DN), focal segmental glomerulosclerosis (FSGS), and treatment-resistant minimal change disease (TR-MCD).
Approximately 125 patients will be enrolled in this study across the United States. Patients with DN and FSGS/TR-MCD will be randomized in 3 ascending dose cohorts to receive either GFB-887 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
University of Alabama at Birmingham
Birmingham, Alabama, United States
Aventiv Research - Phoenix
Mesa, Arizona, United States
Arizona Kidney Disease & Hypertension Centers (AKDHC)
Scottsdale, Arizona, United States
Academic Medical Research Institute (AMRI)
Glendale, California, United States
Amicis Research Center
Granada Hills, California, United States
Percentage change in Urine Protein-to-Creatinine Ratio (UPCR)
Time frame: 12 weeks
Percentage change in Urine Albumin-to-Creatinine Ratio (UACR)
Time frame: 12 weeks
Proportion of FSGS/TR-MCD patients achieving a modified partial remission
Time frame: 12 weeks
Proportion of FSGS/TR-MCD patients achieving a complete remission
Time frame: 12 weeks
Percentage change in 24-hour urine protein excretion
Time frame: 12 weeks
Percentage change in 24-hour urine albumin excretion
Time frame: 12 weeks
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 30% of baseline
Time frame: 12 weeks
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 40% of baseline
Time frame: 12 weeks
Proportion of patients (DN or FSGS/TR-MCD) with a UACR/UPCR decrease of at least 50% of baseline
Time frame: 12 weeks
Incidence and severity of adverse events
Time frame: 12 weeks
Incidence of clinically significant changes in 12-lead electrocardiogram (ECG) parameters, vital signs measurements, and physical examinations
Time frame: Approximately 12 weeks
Incidence of clinically significant changes in laboratory parameters
Time frame: 12 weeks
Plasma pharmacokinetics (PK) parameters: maximum observed plasma concentration (Cmax)
Time frame: 12 weeks
Plasma PK parameters: time of the observed plasma concentration (Tmax)
Time frame: 12 weeks
Plasma PK parameters: area under the plasma concentration-time curve (AUC)
Time frame: 12 weeks
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Amicis Research Center
Northridge, California, United States
Valley Renal Medical Group
Northridge, California, United States
Respire Research - Palm Springs
Palm Springs, California, United States
North American Research Institute
San Dimas, California, United States
...and 64 more locations