This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with diabetic kidney disease (DKD) and albuminuria receiving standard of care treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)
Data are presented as the geometric mean (GM) of percent change, which is calculated as the geometric mean of the Week 16 ACR to baseline, expressed as percent change from baseline.
Time frame: Baseline up to Week 16
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 24 weeks
Percentage of Subjects With TEAEs
Time frame: Up to 24 weeks
Number of Subjects With Adverse Events of Special Interest (AESIs)
Data are presented for treatment-emergent AESIs.
Time frame: Up to 24 weeks
Percentage of Subjects With AESIs
Data are presented for treatment-emergent AESIs.
Time frame: Up to 24 weeks
Observed Value and Mean Change From Baseline in Serum Creatinine
Time frame: Baseline up to 24 weeks
Observed Value and Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline up to 24 weeks
Observed Value and Mean Change From Baseline in Systolic Blood Pressure
Time frame: Baseline up to 24 weeks
Observed Value and Mean Change From Baseline in Diastolic Blood Pressure
Time frame: Baseline up to 24 weeks
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California Kidney Specialists (CKS) - Citrus Office
Covina, California, United States
Valley Research - Fresno
Fresno, California, United States
Torrance Clinical Research (TCR) - Lomita
Lomita, California, United States
Renal Medical Associate/NARI
Lynwood, California, United States
Amicis Research Center
Northridge, California, United States
California Medical Research Associates, Inc
Northridge, California, United States
Riverside Nephrology Group
Riverside, California, United States
West Orange Endocrinology
Ocoee, Florida, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Omega Clinical Research
Metairie, Louisiana, United States
...and 27 more locations
Maximum Concentration (Cmax) After Intravenous (IV) Loading Dose of CSL346 in Serum Samples
Time frame: Up to 120 minutes after the IV loading dose for CSL346
Time to Reach Cmax in Serum (Tmax) After IV Loading Dose of CSL346 in Serum Samples
Time frame: Up to 120 minutes after the IV loading dose for CSL346
Cmax After First Subcutaneous (SC) Dose of CSL346 in Serum Samples
Time frame: From Day 1 to Day 29
Tmax After First SC Dose of CSL346 in Serum Samples
Time frame: From Day 1 to Day 29
Area Under the Concentration-time Curve in First Dosing Interval
Time frame: From Day 1 to Day 29
Trough Concentration After Each Dose
Time frame: 29 days after each dose
Number of Subjects Positive for Anti-drug Antibodies
Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.
Time frame: Weeks 4, 8, and 16
Percentage of Subjects Positive for Anti-drug Antibodies
Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.
Time frame: Weeks 4, 8, and 16