Diabetic Kidney Disease MedDRA version: 21.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Selonsertib
Product Code: GS-4997
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SELONSERTIB
CAS Number: 1448428-04-3
Current Sponsor code: GS-4997
Other descriptive name:
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female between 18 (or = age of majority in each jurisdiction if different than 18) and 80 years of age, inclusive 2) Prior diagnosis of T2DM with diagnostic modalities as per local guidelines. Must have hemoglobin A1c (HbA1c) > 6% within 30 days prior to Enrollment (Visit A) or be on active treatment for T2DM for at least 6 weeks prior to Enrollment (Visit A) 3) eGFRcr value calculated by central laboratory utilizing samples collected during Screening and prior to Enrollment (Visit A) of = 20 mL/min/1.73 m² to =65 years) yes F.1.3.1 Number of subjects for this age range 2310
Exclusion criteria
Exclusion criteria: 1) HbA1c > 12.0% within 30 days prior to Enrollment (Visit A) 2) In the investigator’s opinion, a condition other than T2DM is the primary etiology of DKD 3) If 50 kg/m2 at Enrollment (Visit A) 5) UACR > 5000 mg/g on any measurement during Screening 6) ESRD (i.e., peritoneal dialysis, hemodialysis, or history of kidney transplantation) 7) Anticipated progression to ESRD (need for dialysis or receipt of kidney transplant) within 3 months after Enrollment (Visit A) 8) Unstable CV disease as defined by any of the following: a) Myocardial infarction (MI), coronary artery bypass graft surgery, or coronary angioplasty within 3 months prior to Enrollment (Visit A) b) Transient ischemic attack or cerebrovascular accident within 3 months prior to Enrollment (Visit A) c) Hospitalization for heart failure within 3 months prior to Enrollment (Visit A) d) New York Heart Association (NYHA) Class IV congestive heart failure 9) Diagnostic or interventional procedure that requires intravenous contrast agent within 30 days prior to Enrollment (Visit A) and/or planned during the study Run-in period 10) History of a malignancy with the following exceptions: a) Carcinoma in situ of the cervix b) Basal or squamous cell cancer or other localized non-melanoma skin cancer that has been adequately treated and has not recurred for at least 1 year prior to Enrollment (Visit A) 11) Pregnant or lactating females or planning to become pregnant or breastfeed during the study 12) Concurrent use of a mineralocorticoid receptor antagonist (MRA) or direct renin inhibitor (DRI) in combination with an ACEi or ARB for at least 2 weeks prior to Enrollment 13) Requiring chronic administration of prohibited medications as per protocol 14) Participation in another investigational study within 1 month or within 5 half-lives of the prior investigational agent (whichever is longer) prior to Enrollment (Visit A) 15) Concurrent participation in another therapeutic clinical study 16) Prior participation in any clinical trial of SEL 17) Known hypersensitivity to the study drug (SEL/placebo), the metabolites, or formulation excipients 18) Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results 19) Presence of any condition that could, in the opinion of the investigator, compromise the subject’s ability to participate in the study, such as history of substance abuse, alcoholism, or a psychiatric condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate whether SEL can slow the decline in kidney function, reduce the risk of kidney failure, or reduce the risk of death due to kidney disease in subjects with DKD;Secondary Objective: The secondary objectives of this study are: - To evaluate the effect of SEL on cardiovascular morbidity and mortality in subjects with DKD - To assess the safety and tolerability of SEL in subjects with DKD;Primary end point(s): The primary efficacy endpoint of this study is: • Clinical Endpoint: Time from randomization to the first occurrence of any of the following adjudicated events: - Confirmed = 40% decline in eGFRcys from baseline, or - Kidney failure (dialysis for at least 90 days, kidney transplantation, or confirmed decrease in eGFRcys to < 15 mL/min/1.73 m2 for subjects without dialysis or kidney transplantation), or - Death due to kidney disease ;Timepoint(s) of evaluation of this end point: for Clinical endpoint: The final analysis of this clinical endpoint will be conducted at the global study end date when at least 861 events for the global primary clinical endpoint have been observed in the ITT Analysis Set. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time from randomization to adjudicated CV death or hospitalization for heart failure - Time from randomization to the first occurrence of an adjudicated event in the CV composite endpoint (includes CV death, non-fatal MI, non-fatal stroke, or hospitalization for heart failure) - Time from randomization to adjudicated CV death - Time from randomization to adjudicated atrial fibrillation -Time from randomization to adjudicated CV death or adjudicated kidney failure (dialysis for at least 90 days, kidney transplantation, or confirmed decrease in eGFRcys to < 15 mL/min/1.73 m2 for subjects without dialysis or kidney transplantation) -Time from randomization to adjudicated all-cause death (death occurring during the study from any cause) or adjudicated kidney failure (dialysis for at least 90 days, kidney transplantation, or confirmed decrease in eGFRcys to < 15 mL/min/1.73 m2 for subjects without dialysis or kidney transplantation);Timepoint(s) of evaluation of this end point: If significance is reached for primary analysis of the EU primary clinical endpoint, the key secondary endpoints will be evaluated sequentially at a 0.049 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed