Status:
COMPLETED
Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease
Lead Sponsor:
Gilead Sciences
Conditions:
Diabetic Kidney Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the decline in kidney function in participants with moderate to advanced diabetic kidney disease (DKD).
Detailed Description
Following the screening period, eligible participants will enroll into a Run-in period of at least 5 weeks and receive placebo to match SEL for at least 1 week and then SEL for at least 4 weeks. After...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of type 2 diabetes mellitus (T2DM) as per local guidelines.
- Estimated glomerular filtration rate (eGFR) value calculated by central laboratory utilizing samples collected during screening and prior to enrollment of ≥ 20 mL/min/1.73 m\^2 to \< 60 mL/min/1.73 m\^2 with albuminuria
- eGFR and urine albumin to creatinine ratio (UACR) must meet criteria a, b, or c
- a: eGFR (mL/min/1.73 m\^2): ≥ 45 to \< 60; UACR (mg/g): ≥ 600 to 5000
- b: eGFR (mL/min/1.73 m\^2): ≥ 30 to \< 45; UACR (mg/g): ≥ 300 to 5000
- c: eGFR (mL/min/1.73 m\^2): ≥ 20 to \< 30; UACR (mg/g): ≥ 150 to 5000
- Treatment with either an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
- Individuals not receiving an ACEi or ARB may be enrolled if there is documented intolerance to ACEi and ARB
- Individuals receiving less-than-maximal dose of an ACEi or ARB may be enrolled if there is a documented reason that the maximum labeled dose of ACEi and ARB could not be reached
- Individuals already receiving sodium-glucose co-transporter-2 (SGLT-2) inhibitors must be on a stable dose for at least 2 weeks prior to enrollment
- Mean systolic blood pressure (SBP) must be \<160 mmHg and mean diastolic blood pressure (DBP) must be \<100 mmHg
- Required baseline laboratory data, analyzed by central laboratory, within 30 days prior to enrollment
- Key
Exclusion
- Hemoglobin A1c (HbA1c) \> 12.0% within 30 days prior to enrollment
- Individuals with diagnosis of type 1 diabetes mellitus (T1DM) or maturity onset diabetes of the young (MODY)
- Body mass index (BMI) \> 50 kg/m\^2
- UACR \> 5000 mg/g on any measurement during screening
- End stage kidney disease (ESKD) (i.e., chronic hemodialysis, chronic peritoneal dialysis, or history of kidney transplantation)
- Anticipated progression to ESKD (need for chronic hemodialysis, chronic peritoneal dialysis or receipt of kidney transplant) within 3 months after enrollment
- Unstable cardiovascular disease
- Pregnant or lactating females or planning to become pregnant or breastfeed during the study
- Concurrent use of either
- ACEi and ARB or
- Mineralocorticoid receptor antagonist (MRA) or direct renin inhibitor (DRI) in combination with an ACEi or ARB for at least 2 weeks prior to Enrollment
- 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 individual or impair the assessment of study results
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
July 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2021
Estimated Enrollment :
384 Patients enrolled
Trial Details
Trial ID
NCT04026165
Start Date
July 24 2019
End Date
September 3 2021
Last Update
December 21 2022
Active Locations (111)
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1
Arizona Kidney Disease and Hypertension Centers
Glendale, Arizona, United States, 85306
2
AKDHC Medical Research Services, LLC
Tucson, Arizona, United States, 85712
3
Clearview Medical Research, LLC
Canyon Country, California, United States, 91350
4
Kidney Disease Medical Group, Inc.
Glendale, California, United States, 91206