Diabetic Kidney DiseasePhase 2NCT02177786

Efficacy, Safety, and Tolerability of Selonsertib (GS-4997) in Participants With Diabetic Kidney Disease

A Phase 2 study testing Selonsertib in people with Diabetic Kidney Disease, run by Gilead Sciences at 105 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetic Kidney Disease
What is being tested?: Selonsertib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 334 participants
Where: 105 sitesin 2 countries
Study dates: Jun 2014to Aug 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult male or females with prior diagnosis of Diabetic Kidney Disease
Type 2 diabetes mellitus diagnosis for at least 6 months
eGFR (MDRD) at screening ≥ 15 mL/min/1.73m^2 to < 60 mL/min/1.73m^2
Urine albumin to creatinine ratio (UACR) as follows:
Stage/Stratum 3a: eGFR range 45 to < 60 mL/min; UACR ≥ 600 mg/g
Stage/Stratum 3b: eGFR range 30 to < 45 mL/min; UACR ≥ 300 mg/g

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Stage/Stratum 4: eGFR range 15 to < 30 mL/min; UACR ≥ 150 mg/g
Receiving angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blockers (ARB) at a minimum dose deemed appropriate for the individual by the investigator and be at a stable dose for the last three months
Individuals not on ACEi/ARB may be screened if there is documented intolerance to ACE inhibitor and/or ARB

Who cannot join

Type 1 diabetes mellitus
HbA1c > 9.5%
Non-diabetic kidney disease
UACR > 5000 mg/g on any measurement during screening
End stage renal disease (ESRD; receiving peritoneal dialysis, hemodialysis, or status post renal transplantation) or anticipated to occur within the treatment period
Unstable cardiovascular disease
Pregnant or lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

105 sites in 2 countries.

Country

City, postcode or hospital

105 sites in 2 countries

United States100 sites

Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Arlington Nephrology
Arlington, Texas, 76015
Mountain Kidney and Hypertension Associates
Asheville, North Carolina, 28801
North America Research Institute
Azusa, California, 91702
Johns Hopkins Hospital/University
Baltimore, Maryland, 21205
MW Clinical Research Center
Beaumont, Texas, 77701
Bend Memorial Clinic
Bend, Oregon, 97701
A. Kaldun Nossuli MD Research
Bethesda, Maryland, 20814
The University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294
Val R. Hansen, M.D.
Bountiful, Utah, 84010
Fletcher Allen Health Care
Burlington, Vermont, 05401
Mercury Street Medical Group, PLLC, Big Sky Clinical Research, LLC
Butte, Montana, 59701
University of Virginia
Charlottesville, Virginia, 22908
Southeast Renal Research Institute
Chattanooga, Tennessee, 37408
John H. Stroger Jr. Hospital Of Cook County
Chicago, Illinois, 60612
California Institute of Renal Research
Chula Vista, California, 91910
Hightop Medical Research Center
Cincinnati, Ohio, 45231
Rockdale Medical Research Associates
Conyers, Georgia, 30094
Padre Coast Clinical Research
Corpus Christi, Texas, 78404
Corsicana Medical Research, PLLC
Corsicana, Texas, 75110
West Broadway Clinic
Council Bluffs, Iowa, 51501
Midwest Endocrinology
Crystal Lake, Illinois, 60012
Omega Research Consultants
DeBary, Florida, 32713
Creekside Medical Research
DeLand, Florida, 32720
Wayne State University
Detroit, Michigan, 48201
Riverside Clinical Research
Edgewater, Florida, 32132
California Institute of Renal Research Inc.
El Centro, California, 92243
Texas Tech Univ. Health Sciences Center
El Paso, Texas, 79905
Apex Medical Research.Com
Flint, Michigan, 48504
Elite Clinical Research
Flint, Michigan, 48532
Nephrology Associates, PC
Flushing, New York, 11355
TVC Clinical Research
Gonzales, Texas, 78629
Renal Consultants Medical Group Granada Hills
Granada Hills, California, 91344
Clinical Research Connections, LLC
Harrisburg, Arkansas, 72432
Diagnostic Clinic of Houston
Houston, Texas, 77004
Mercury Clinical Research
Houston, Texas, 77036
Lakewood Family Practice
Houston, Texas, 77070
Southwest Clinical Trials
Houston, Texas, 77074
Southwest Houston Research, Ltd.
Houston, Texas, 77099
Chase Medcare
Huntsville, Alabama, 35811
Hutchinson Clinic, P.A
Hutchinson, Kansas, 67502
ASA Clinical Research
Jupiter, Florida, 33458
VA Medical Center
Kansas City, Missouri, 64128
FPA Clinical Research
Kissimmee, Florida, 34741
The Chappel Group LLC
Kissimmee, Florida, 34741
Knoxville Kidney Center
Knoxville, Tennessee, 37923
Research Nurse Specialists, LLc
Lafayette, Louisiana, 70503
South Florida Research Institute
Lauderdale Lakes, Florida, 33313
Torrance Clinical Research
Lomita, California, 90717
IMD Medical Group
Los Angeles, California, 90020
Academic Medical Research Institute
Los Angeles, California, 90022
L-MARC Research Center
Louisville, Kentucky, 40213
Kidney Research Center
Lynwood, California, 90262
University of Wisconsin
Madison, Wisconsin, 53713
Craig S Thompson MD LLC
Marion, Ohio, 43302
Your Diabetes Endocrine Nutrition Group Inc
Mentor, Ohio, 44060
Crescent City Clinical Research Center
Metairie, Louisiana, 70006
Prestige Clinical Research Center Inc
Miami, Florida, 33133
International Physicians Research / Nephrology Associates of South Miami
Miami, Florida, 33173
Tellus Clinical Research, Inc
Miami, Florida, 33173
Coral Research Clinic Corp
Miami, Florida, 33175
Zablocki VAMC
Milwaukee, Wisconsin, 53295
Beacon Medical Group Kidney and Hypertension Center
Mishawaka, Indiana, 46544
Tulane University
New Orleans, Louisiana, 70112
Internal Medicine Specialists
New Orleans, Louisiana, 70115
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Discovery Medical Research Group
Ocala, Florida, 34471
Chris Sholer, MD, PC
Oklahoma City, Oklahoma, 73116
Alegent Creighton Health
Omaha, Nebraska, 68131
Creighton Diabetes Center
Omaha, Nebraska, 68131
Central Florida Internists
Orlando, Florida, 32811
Four Rivers Clinical Research
Paducah, Kentucky, 42003
Sunset Point Medical Associates DBA
Palm Harbor, Florida, 34684
HMRI CCAT Pearland
Pearland, Texas, 77584
Pines Clinical Research Inc.
Pembroke Pines, Florida, 33028
Akdhc Medical Research Services, Llc
Peoria, Arizona, 85381
Akdhc Medical Research Services, Llc
Phoenix, Arizona, 85012
Akdhc Medical Research Services, Llc
Phoenix, Arizona, 85027
Akdhc Medical Research Services, Llc
Prescott, Arizona, 86301
Apex Research of Riverside
Riverside, California, 92505
Boice-Willis Clinic
Rocky Mount, North Carolina, 27804
Green Clinic LLC
Ruston, Louisiana, 71270
Central Florida Internists
Saint Cloud, Florida, 34769
Clinical Advancement Center, PLLC
San Antonio, Texas, 78215
Briggs Clinical Research, LLC
San Antonio, Texas, 78224
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
San Francisco General Hospital
San Francisco, California, 94110
Clearview Medical Research, LLC
Santa Clarita, California, 91350
Carolina Research Center
Shelby, North Carolina, 28150
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101
Robert J. Bloomberg, MD
Tempe, Arizona, 85283
Choice Medicine
Toney, Alabama, 35773
Troy Internal Medicine, PC
Troy, Michigan, 48098
AKDHC East Office
Tucson, Arizona, 85712
Nephrology and Hypertension Associates of New Jersey
Voorhees Township, New Jersey, 08043
American Institute of Research
Whittier, California, 90603
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, 67214
Florida Pulmonary Research Institute
Winter Park, Florida, 32789
Southern Clinical Research
Zachary, Louisiana, 70791

Other trials in United States

Canada5 sites

Co-Medica Research Network
Courtice, Ontario, L1E 3C3
Clinical Research Solutions, Inc.
Kitchener, Ontario, N2H 5Z8
OTT Healthcare Inc.
Scarborough Village, Ontario, M1H 3G4
Toronto East General Medical Centre
Toronto, Ontario
BC Diabetes
Vancouver, British Columbia, V5Z1M9

Other trials in Canada

About this study

Official title: A Phase 2, Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GS-4997 in Subjects With Diabetic Kidney Disease

The primary objective of this study is to determine the effect of selonsertib (formerly GS-4997) on estimated glomerular filtration rate (eGFR) decline in participants with diabetic kidney disease (DKD). Participants will be randomized with a 1:1:1:1 allocation to receive 1 of 3 doses of selonsertib (2 mg, 6 mg, or 18 mg) or matching placebo.

Conditions: Diabetic Kidney Disease
Being tested: Selonsertib, Placebo to match selonsertib
Keywords: Diabetic Kidney Disease, Gilead
Medical subject headings: Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SelonsertibDrug
Also called GS-4997
Tablets administered orally once daily
Placebo to match selonsertibDrug
Tablets administered orally once daily

Study groups in NCT02177786
Study group	Role	What they receive
Selonsertib 2 mg	Experimental	Participants will receive selonsertib 2 mg for 48 weeks. Receives: Drug: Selonsertib
Selonsertib 6 mg	Experimental	Participants will receive selonsertib 6 mg for 48 weeks. Receives: Drug: Selonsertib
Selonsertib 18 mg	Experimental	Participants will receive selonsertib 18 mg for 48 weeks. Receives: Drug: Selonsertib
Placebo to match selonsertib	Placebo comparator	Participants will receive placebo to match selonsertib for 48 weeks. Receives: Drug: Placebo to match selonsertib

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in eGFR From Baseline at Week 48
The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine^-1.154 × age^-0.203 × 1.212 (if participant is black) × 0.742 (if female).
Measured: Baseline; Week 48

Secondary outcomes (1)

Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48
Baseline was the average of the last 2 values prior to randomization and the last value on or after the randomization date, but prior to or on the first dose date. Urine Albumin to Creatinine Ratio= urine albumin/urine creatinine.
Measured: Baseline; Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2014Aug 2016

First posted30 Jun 2014 (estimated)
Study startJun 2014
Primary completionJul 2016
Study completionAug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 334 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02177786
Sponsor's protocol ID: GS-US-223-1015
Status last verified: Oct 2019
First submitted: 26 Jun 2014
Last updated: 5 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Chertow GM, Pergola PE, Chen F, Kirby BJ, Sundy JS, Patel UD; GS-US-223-1015 Investigators. Effects of Selonsertib in Patients with Diabetic Kidney Disease. J Am Soc Nephrol. 2019 Oct;30(10):1980-1990. doi: 10.1681/ASN.2018121231. Epub 2019 Sep 10.
PubMed 31506292
Tesch GH, Ma FY, Han Y, Liles JT, Breckenridge DG, Nikolic-Paterson DJ. ASK1 Inhibitor Halts Progression of Diabetic Nephropathy in Nos3-Deficient Mice. Diabetes. 2015 Nov;64(11):3903-13. doi: 10.2337/db15-0384. Epub 2015 Jul 15.
PubMed 26180085

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Double-Blind, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GS-4997 in Subjects With Diabetic Kidney Disease
ClinicalTrials.gov ID: NCT02177786
Acronym / sponsor ID: GS-US-223-1015
Conditions: Diabetic Kidney Disease
Keywords: Diabetic Kidney Disease, Gilead
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 334 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Jul 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 30 Jun 2014 (estimated)
Results: Posted 11 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Selonsertib 2 mg	Experimental	Drug: SelonsertibParticipants will receive selonsertib 2 mg for 48 weeks.
Selonsertib 6 mg	Experimental	Drug: SelonsertibParticipants will receive selonsertib 6 mg for 48 weeks.
Selonsertib 18 mg	Experimental	Drug: SelonsertibParticipants will receive selonsertib 18 mg for 48 weeks.
Placebo to match selonsertib	Placebo comparator	Drug: Placebo to match selonsertibParticipants will receive placebo to match selonsertib for 48 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Adult male or females with prior diagnosis of Diabetic Kidney Disease
Type 2 diabetes mellitus diagnosis for at least 6 months
eGFR (MDRD) at screening ≥ 15 mL/min/1.73m^2 to < 60 mL/min/1.73m^2
Urine albumin to creatinine ratio (UACR) as follows:
Receiving angiotensin-converting-enzyme inhibitor (ACEi) or angiotensin receptor blockers (ARB) at a minimum dose deemed appropriate for the individual by the investigator and be at a stable dose for the last three months

Key exclusion criteria (8 listed)

Type 1 diabetes mellitus
HbA1c > 9.5%
Non-diabetic kidney disease
UACR > 5000 mg/g on any measurement during screening
End stage renal disease (ESRD; receiving peritoneal dialysis, hemodialysis, or status post renal transplantation) or anticipated to occur within the treatment period

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SelonsertibAlso: GS-4997Tablets administered orally once daily	Drug	Selonsertib 18 mg, Selonsertib 2 mg, Selonsertib 6 mg
Placebo to match selonsertibTablets administered orally once daily	Drug	Placebo to match selonsertib

Primary outcome

Change in eGFR From Baseline at Week 48
Time frame: Baseline; Week 48
The values of eGFR were calculated using the MDRD equation: eGFR = 175 x Serum Creatinine^-1.154 × age^-0.203 × 1.212 (if participant is black) × 0.742 (if female).

1 secondary outcome

Percentage of Participants Achieving at Least a 30% Reduction From Baseline in Albuminuria (As Measured by Urine Albumin to Creatinine Ratio) at Week 48
Time frame: Baseline; Week 48

Results and safety

Results posted to the registry on 11 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Selonsertib 2 mg	81	75
Selonsertib 6 mg	84	70
Selonsertib 18 mg	84	66
Placebo	85	72

Primary outcome: Change in eGFR From Baseline at Week 48

Time frame: Baseline; Week 48. Mean (Standard Error). Unit: mL/min/1.73 m^2

Measure	Selonsertib 2 mg n = 81	Selonsertib 6 mg n = 84	Selonsertib 18 mg n = 83	Placebo n = 85
Value	-2.83 (0.86)	-2.37 (0.87)	-4.07 (0.89)	-3.20 (0.85)

Selonsertib 2 mg vs Placebo: Least Square Means Difference: 0.38 (95% CI -2.00 to 2.75), p = 0.755, MMRM
Selonsertib 6 mg vs Placebo: Least Square Means Difference: 0.84 (95% CI -1.55 to 3.23), p = 0.492, MMRM
Selonsertib 18 mg vs Placebo: Least Square Means Difference: -0.87 (95% CI -3.29 to 1.56), p = 0.481, MMRM

Population analysed: Full Analysis Set included all randomized participants who took at least 1 dose of study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: First dose date up to Week 48 plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Selonsertib 2 mg	24 of 81 (29.6%)	51 of 81 (63%)	Not reported
Selonsertib 6 mg	20 of 84 (23.8%)	47 of 84 (56%)	Not reported
Selonsertib 18 mg	20 of 83 (24.1%)	55 of 83 (66.3%)	Not reported
Placebo	16 of 85 (18.8%)	48 of 85 (56.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31506292Chertow GM, Pergola PE, Chen F, Kirby BJ, Sundy JS, Patel UD; GS-US-223-1015 Investigators. Effects of Selonsertib in Patients with Diabetic Kidney Disease. J Am Soc Nephrol. 2019 Oct;30(10):1980-1990. doi: 10.1681/ASN.2018121231. Epub 2019 Sep 10.
Derived from this study: PubMed 26180085Tesch GH, Ma FY, Han Y, Liles JT, Breckenridge DG, Nikolic-Paterson DJ. ASK1 Inhibitor Halts Progression of Diabetic Nephropathy in Nos3-Deficient Mice. Diabetes. 2015 Nov;64(11):3903-13. doi: 10.2337/db15-0384. Epub 2015 Jul 15.

Related trials for Diabetic Kidney Disease

Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

105 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selonsertib in people with Diabetic Kidney Disease, run by Gilead Sciences at 105 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in eGFR From Baseline at Week 48 (time frame: Baseline; Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02177786, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.