After each study subject qualifies, they will be assigned to one of the 5 treatment groups. The participants of each group will be given multiple doses of study drug at different dose levels. A computer will automatically assign the subject to one of the dose levels as well as whether the subject are placed in the placebo or active drug group. Neither the study doctor and study staff will know who is assigned to placebo or active drug.The total duration of this study is 26 weeks, and the study subject will have a total of 17 visits over this periodMore
Males and females must be 18-75 years of age for DN, FSGS, and TR-MCD diagnosis. Diagnosis of type 2 diabetes with a HbA1c level of less than or equal to 10% at screening. Diagnosis of FSGS or TR-MCD based on either biopsy or FSGS based on genetic testiing.
Inclusion criteria for DN: -Persistent albuminuria defined as: ---i. The average UACR during the Screening visit is 150 mg/g to 3500 mg/g. --- ii The average UACR during the Run-in visit is 150 mg/g to 3500 mg/g. -Estimated glomerular filtration rate (eGFR) greater or equal to 45mL/min/1.73m2 at screening. -Currently receiving an ACE or ARB at least 3 months prior to screening and stable for 4 weeks prior ---to screening. Exclusion Criteria for DN: -Uncontrolled blood pressure defined as greater than 160/90mmHG. -Immunosuppressive therapy currently -Positive HIV or current active Hep B or C infections -Severe cardiovascular disease Inclusion Criteria for FSGS/TR-MCD -Persistent proteinuria defined as: ---i. Average UPCR at screening and Run-in visit is greater than or equal to 1.0 g/g --ii. UPCR measurements in 2 out of 3 urine samples (first morning voids, FMV) at screening and Run------in visits are greater than or equal to 1.0 g/g -eGFR is greater than or equal to 45 mL/min/1.73 m2 at screening -Currently receiving an ACE or ARB at least 3 months prior to screening and stable for 4 weeks prior ---to screening. -If currently on corticosteroids or MMF, must have received for at least 3 months prior to screening, and stable for 4 weeks prior to screening. Exclusion Criteria for FSGS/TR-MCD - Uncontrolled blood pressure of greater than 160/90 mmHG - Currently on CNIs -Received rituximab or cyclophosphamide within the last 120 days prior to screening
University of Colorado Hospital
Amber Podoll, MD
Protocol Number: 20-1341
More information available at ClinicalTrials.gov: NCT04235621
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