Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01752985
• Collaborator: (none)
• Enrollment: 319
• Locations: 62
• Arms: 3
• Actual Duration (Months): 27.4
• Patients Per Site: 5.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether BMS-813160 will reduce the amount of protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease

Condition or Disease	Intervention/Treatment	Phase
Diabetic Kidney Disease	Drug: BMS-813160; Drug: Placebo matching with BMS-813160	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 319 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blind, Placebo-Controlled, Randomized, Two-stage, Parallel-Group, Adaptive Design Phase 2a Study to Evaluate the Effects of BMS-813160 in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease (DKD) Who Have Residual Macroalbuminuria Despite Treatment With an Inhibitor of the Renin-Angiotensin System
• Actual Study Start Date: Mar 18, 2013
• Actual Primary Completion Date: Jun 30, 2015
• Actual Study Completion Date: Jun 30, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: BMS-813160 150 mg & Placebo matching with BMS-813160 BMS-813160 150 mg capsules by mouth in AM and Placebo matching with BMS-813160 in PM for 12 weeks	Drug: BMS-813160; Drug: Placebo matching with BMS-813160
Experimental: Arm B: BMS-813160 300 mg BMS-813160 300 mg capsules by mouth twice daily for 12 weeks	Drug: BMS-813160
Placebo Comparator: Arm C: Placebo matching with BMS-813160 Placebo matching with BMS-813160 0 mg capsules by mouth twice daily for 12 weeks	Drug: Placebo matching with BMS-813160

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160 [Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)]

   The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period.

Secondary Outcome Measures

1. Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events [From the date of subject's written consent until 30 days post discontinuation of dosing, assessed up to 26 months]

   An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.

2. Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval [Baseline up to Week 16]

   12-lead ECGs were performed before and 1 hour after dosing at Weeks 0, 2 and 4. ECGs were recorded after the participant has been supine for at least 5 minutes. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. Participants were evaluated for abnormal ECG intervals. Criteria's for abnormality were PR >200, QRS >120, QT >500, QTcF >450, Change From Baseline >30 milliseconds (msec).

3. Trough Observed Plasma Concentration (Ctrough) of BMS-813160 [Pre-dose at Week 2, 4, 8, 12 and 0.5, 1, 2, 4, and 6 hours post-dose at Week 12]

   Ctrough is the minimum estimated plasma concentration at steady state.

4. Area Under The Plasma Concentration-Time Curve From Time Zero to 6 Hours Post-Dose [AUC(0-6 h)] [Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12]

   AUC(0-6 h) is the area under the plasma concentration-time curve from pre-dose (0 h) to 6 h post-dose.

5. Renal Clearance (CLr) of BMS-813160 [Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12]

   CLr was calculated by dividing the total amount excreted in the urine from 0 to 6 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The renal function was classified based on estimated glomerular filtration rate as normal (>=90 mL/min/1.73 m^2), mildly impaired (60-89 mL/min/1.73 m^2), moderately impaired stage 3A (45-59 mL/min/1.73 m^2), and moderately impaired stage 3B (30-44 L/min/1.73 m^2).

6. Dose-Response Relationship Using Change in Baseline Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment [Baseline, Weeks 2, 4, 8 and 12]

   The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period. The effect of BMS-813160 on urinary albumin excretion as measured by UACR values in participants with diabetic kidney disease after 12 weeks of treatment was assessed. The model included treatment group as a main effect, and the log of baseline UACR values, as well as baseline values of eGFR, blood pressure, blood glucose and lipid levels, as covariates.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Clinical diagnosis of type 2 diabetes mellitus with macroalbuminuria (UACR between 200 and 3500 mg/g)

• Background angiotensin converting enzyme inhibitor (ACEI) or angiotensin-receptor blocker (ARB) therapy

Exclusion Criteria:

• Clinical diagnosis of type 1 diabetes

• Unstable cardiovascular, metabolic, or other chronic disease status

• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2

• High risk of infection or immune compromise

• Clinically significant ECG conduction abnormalities

• Drugs with significant potential to affect BMS-813160 exposure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uab Hospital	Birmingham	Alabama	United States	35294
2	Univ Of Al At Birmingham	Birmingham	Alabama	United States	35294
3	Akdhc Medical Research Services Llc	Phoenix	Arizona	United States	85012
4	Academic Medical Research Institute	Los Angeles	California	United States	90022
5	Ucla	Los Angeles	California	United States	90025
6	Providence Clinical Research	North Hollywood	California	United States	91606
7	Diabetes Medical Center Of California	Northridge	California	United States	91325
8	Diablo Clinical Research, Inc.	Walnut Creek	California	United States	94598
9	George Washington University Medical Faculty Associates	Washington	District of Columbia	United States	20037
10	All Medical Research, Llc	Cooper City	Florida	United States	33024
11	International Research Associates, Llc	Hialeah	Florida	United States	33012
12	Genesis Clinical Research, Inc.	Tampa	Florida	United States	33614
13	Emory University School Of Medicine	Atlanta	Georgia	United States	30303
14	Endocrine Research Solutions, Inc.	Roswell	Georgia	United States	30076
15	John H. Stroger, Jr. Hospital Of Cook County	Chicago	Illinois	United States	60612
16	Research By Design, Llc	Evergreen Park	Illinois	United States	60805
17	St Louis Center Clinl Res	Saint Louis	Missouri	United States	63128
18	St. Louis Center For Clinical Research	Saint Louis	Missouri	United States	63128
19	Va Nebraska-Western Iowa Health Care System (Nwihcs)	Omaha	Nebraska	United States	68105
20	Southern Nh Diab And Endo	Nashua	New Hampshire	United States	03063
21	Premier Research, Inc.	Trenton	New Jersey	United States	08611
22	Albany Medical College	Albany	New York	United States	12206
23	The Endocrine Group Llp	Albany	New York	United States	12206
24	Nephrology Associates	Flushing	New York	United States	11355
25	Medispect Medical Research, Llc	Boone	North Carolina	United States	28607
26	Metrolina Internal Medicine	Charlotte	North Carolina	United States	28204
27	Duke University	Durham	North Carolina	United States	27705
28	Ohio State University Medical Center	Columbus	Ohio	United States	43210
29	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210
30	Paramount Medical Research & Consulting, Llc	Middleburg Heights	Ohio	United States	44130
31	Physician Research, Inc.	Zanesville	Ohio	United States	43701
32	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
33	Piedmont Health Grp, Llc-Twr Pt Res Ctr	Hodges	South Carolina	United States	29653
34	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232-1371
35	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
36	Doctors Hospital At Renaissance	Edinburg	Texas	United States	78539
37	San Antonio Military Medical Center	Fort Sam Houston	Texas	United States	78234-6200
38	San Antonio Military Medical Center	Fort Sam Houston	Texas	United States	78234
39	Northeast Clinical Research Of San Antonio, Llc	Schertz	Texas	United States	78154
40	Burke Internal Medicine And Research	Burke	Virginia	United States	22015
41	Virginia Endocrinology Research	Chesapeake	Virginia	United States	23321
42	Manassas Clinical Research Center	Manassas	Virginia	United States	20110
43	Mcguire Va Medical Center	Richmond	Virginia	United States	23249
44	Health Sciences Centre Diabetes Research Centre	Winnipeg	Manitoba	Canada	R3A 1R9
45	Eastern Health Sciences Center	St. John's	Newfoundland and Labrador	Canada	A1B 3V6
46	Aggarwal And Associates	Brampton	Ontario	Canada	L6T 0G1
47	Clinical Research Solutions, Inc	Kitchener	Ontario	Canada	N2H 5Z8
48	Lmc Diabetes & Endocrinology (Thornhill)	Thornhill	Ontario	Canada	L4J 8L7
49	Lmc Diabetes & Endocrinology (Bayview)	Toronto	Ontario	Canada	M4G 3E8
50	Centre De Recherche Clinique De Laval	Laval	Quebec	Canada	H7T 2P5
51	Recherche Gcp Research	Montreal	Quebec	Canada	H2R 1V6
52	Local Institution	Montreal	Quebec	Canada	H3T 1E2
53	Local Institution	Frederiksberg		Denmark	2000
54	Local Institution	Gentofte		Denmark	2820
55	Local Institution	Hillerod		Denmark	3400
56	Local Institution	Holstebro		Denmark	7500
57	Local Institution	Amiens Cedex 1		France	80054
58	Local Institution	Grenoble Cedex 9		France	F38043
59	Local Institution	Nantes Cedex 1		France	44093
60	Local Institution	Paris		France	75877
61	Local Institution	Poitiers Cedex		France	86021
62	Local Institution	Tours Cedex 09		France	37044

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Patient Recruiting

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01752985
• Other Study ID Numbers: CV202-010; 2012-005093-54
• First Posted: Dec 19, 2012
• Last Update Posted: Jul 30, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Kidney Diseases; Diabetic Nephropathies

Study Results

Participant Flow

Pre-assignment Detail	319 were enrolled, 110 completed screening, rest 209 discontinued: (Main reason:did not meet study criteria). Of 110 screened, 98 entered Placebo Lead-in period of which 89 completed period, rest 9 discontinued (2 due to Admin. reason, 3 no longer met study criteria, 2 AEs and 2 were lost to follow-up.)1 was randomized but declined treatment

Arm/Group Title	BMS-813160 150 mg QD	BMS-813160 300 mg BID	Placebo
Arm/Group Description	Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
Period Title: Treatment Period
STARTED	29	30	29
COMPLETED	25	27	24
NOT COMPLETED	4	3	5
Period Title: Treatment Period
STARTED	28	27	26
COMPLETED	28	27	26
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	BMS-813160 150 mg QD	BMS-813160 300 mg BID	Placebo	Total
Arm/Group Description	Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.	Total of all reporting groups
Overall Participants	29	30	29	88
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	63.9 (9.58)	60.2 (8.31)	60.6 (11.52)	61.5 (9.90)
Age, Customized (Number) [Number]
<65 years	14 48.3%	17 56.7%	17 58.6%	48 54.5%
>=65 years	15 51.7%	13 43.3%	12 41.4%	40 45.5%
Sex: Female, Male (Count of Participants)
Female	2 6.9%	7 23.3%	8 27.6%	17 19.3%
Male	27 93.1%	23 76.7%	21 72.4%	71 80.7%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160
Description	The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period.
Time Frame	Baseline, Weeks 2, 4, 8, 12, and 16 (Follow-up)

Outcome Measure Data

Analysis Population Description

The analysis was performed in all the participants who received any study drug. Here, 'n' signifies evaluable participants for specified categories in respective treatment arms.

Arm/Group Title	BMS-813160 150 mg QD	BMS-813160 300 mg BID	Placebo
Arm/Group Description	Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
Measure Participants	29	30	29
Week 2	5.78 (48.994)	3.79 (62.795)	2.05 (30.771)
Week 4	18.43 (62.661)	5.81 (83.274)	1.46 (40.051)
Week 8	19.49 (65.381)	9.87 (56.557)	5.68 (43.659)
Week 12	6.91 (56.666)	29.16 (78.69)	8.91 (54.025)
Week 16	0.97 (61.72)	20.63 (85.578)	23.77 (70.411)

2. Secondary Outcome

Title	Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events
Description	An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.
Time Frame	From the date of subject's written consent until 30 days post discontinuation of dosing, assessed up to 26 months

Outcome Measure Data

Analysis Population Description

The analysis was performed in all the participants who received any study drug.

Arm/Group Title	BMS-813160 150 mg QD	BMS-813160 300 mg BID	Placebo
Arm/Group Description	Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
Measure Participants	29	30	29
SAEs	3 10.3%	3 10%	1 3.4%
Death	0 0%	1 3.3%	0 0%
Other (Non-Serious) Adverse Events 5 % cut-off	3 10.3%	2 6.7%	4 13.8%

3. Secondary Outcome

Title	Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval
Description	12-lead ECGs were performed before and 1 hour after dosing at Weeks 0, 2 and 4. ECGs were recorded after the participant has been supine for at least 5 minutes. The PR interval was defined as the beginning of the P wave to the beginning of the QRS complex, and represents the time taken by electrical impulse to travel from the sinus node through the atrioventricular (AV) node. The QRS complex represented the rapid depolarization of the right and left ventricles. The QT interval was defined as the time from the start of the Q wave to the end of the T wave, and represents the time taken for ventricular depolarization and repolarization. Participants were evaluated for abnormal ECG intervals. Criteria's for abnormality were PR >200, QRS >120, QT >500, QTcF >450, Change From Baseline >30 milliseconds (msec).
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

The analysis was performed in all the participants who received any study drug.

Arm/Group Title	BMS-813160 150 mg QD	BMS-813160 300 mg BID	Placebo
Arm/Group Description	Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
Measure Participants	29	30	29
PR >200 msec	8 27.6%	8 26.7%	4 13.8%
QRS >120 msec	3 10.3%	3 10%	3 10.3%
QT >500 msec	0 0%	1 3.3%	0 0%
QTcF >450 msec	7 24.1%	5 16.7%	6 20.7%
Change from baseline in QT >30 msec	8 27.6%	6 20%	4 13.8%
Change from baseline in QTcF >30 msec	4 13.8%	3 10%	1 3.4%

4. Secondary Outcome

Title	Trough Observed Plasma Concentration (Ctrough) of BMS-813160
Description	Ctrough is the minimum estimated plasma concentration at steady state.
Time Frame	Pre-dose at Week 2, 4, 8, 12 and 0.5, 1, 2, 4, and 6 hours post-dose at Week 12

Outcome Measure Data

Analysis Population Description

The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all participants who receive a dose of study drug and have adequate PK concentration-time data. Data was not collected for any participants due to termination of the study

Arm/Group Title	BMS-813160 150 mg QD	BMS-813160 300 mg BID	Placebo
Arm/Group Description	Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
Measure Participants	0	0	0

5. Secondary Outcome

Title	Area Under The Plasma Concentration-Time Curve From Time Zero to 6 Hours Post-Dose [AUC(0-6 h)]
Description	AUC(0-6 h) is the area under the plasma concentration-time curve from pre-dose (0 h) to 6 h post-dose.
Time Frame	Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12

Outcome Measure Data

Analysis Population Description

The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all participants who receive a dose of study drug and have adequate PK concentration-time data. Data was not collected for any participants due to termination of the study

Arm/Group Title	BMS-813160 150 mg QD	BMS-813160 300 mg BID	Placebo
Arm/Group Description	Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
Measure Participants	0	0	0

6. Secondary Outcome

Title	Renal Clearance (CLr) of BMS-813160
Description	CLr was calculated by dividing the total amount excreted in the urine from 0 to 6 hours by the area under the plasma concentration-time curve from time zero extrapolated to infinite time. The renal function was classified based on estimated glomerular filtration rate as normal (>=90 mL/min/1.73 m^2), mildly impaired (60-89 mL/min/1.73 m^2), moderately impaired stage 3A (45-59 mL/min/1.73 m^2), and moderately impaired stage 3B (30-44 L/min/1.73 m^2).
Time Frame	Pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose at Week 12

Outcome Measure Data

Analysis Population Description

The analysis was planned to be performed in the Pharmacokinetic (PK) analysis set which included all participants who receive a dose of study drug and have adequate PK concentration-time data.Data was not collected for any participants due to termination of the study

Arm/Group Title	BMS-813160 150 mg QD	BMS-813160 300 mg BID	Placebo
Arm/Group Description	Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
Measure Participants	0	0	0

7. Secondary Outcome

Title	Dose-Response Relationship Using Change in Baseline Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment
Description	The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples. UACR was calculated as the geometric mean of two first-morning void urine UACR measurements with samples collected on two separate occasions within a 4-day period. The effect of BMS-813160 on urinary albumin excretion as measured by UACR values in participants with diabetic kidney disease after 12 weeks of treatment was assessed. The model included treatment group as a main effect, and the log of baseline UACR values, as well as baseline values of eGFR, blood pressure, blood glucose and lipid levels, as covariates.
Time Frame	Baseline, Weeks 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Data was not collected for any participants due to termination of the study

Arm/Group Title	BMS-813160 150 mg QD	BMS-813160 300 mg BID	Placebo
Arm/Group Description	Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.	Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks and were followed up for 4 weeks post treatment.
Measure Participants	0	0	0

Adverse Events

Time Frame	From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months
Arm/Group Title	BMS-813160 150 mg QD		BMS-813160 300 mg BID		Placebo
Arm/Group Description	Participants received BMS-813160 150 mg, capsule, orally along with matching placebo in Ante Meridiem (AM) and 2 Placebo matching with BMS-813160, capsules, orally in Post Meridiem (PM) for 12 weeks. Participants were followed up for 4 weeks post treatment.		Participants received 2 BMS-813160 150 mg capsules, orally, twice daily (2*150 in AM and 2*150 in PM) for 12 weeks.		Participants received BMS-813160 matching placebo capsules, orally, twice daily in AM and PM for 12 weeks.
All Cause Mortality
	BMS-813160 150 mg QD		BMS-813160 300 mg BID		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		1/30 (3.3%)		0/29 (0%)
Serious Adverse Events
	BMS-813160 150 mg QD		BMS-813160 300 mg BID		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/29 (10.3%)		3/30 (10%)		1/29 (3.4%)
Cardiac disorders
Angina pectoris	0/29 (0%)		0/30 (0%)		1/29 (3.4%)
Coronary artery occlusion	0/29 (0%)		0/30 (0%)		1/29 (3.4%)
Angina unstable	1/29 (3.4%)		0/30 (0%)		0/29 (0%)
General disorders
Death	0/29 (0%)		1/30 (3.3%)		0/29 (0%)
Infections and infestations
Lobar pneumonia	0/29 (0%)		1/30 (3.3%)		0/29 (0%)
Metabolism and nutrition disorders
Hypoglycaemia	0/29 (0%)		1/30 (3.3%)		0/29 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma	1/29 (3.4%)		0/30 (0%)		0/29 (0%)
Nervous system disorders
Transient ischaemic attack	1/29 (3.4%)		0/30 (0%)		0/29 (0%)
Skin and subcutaneous tissue disorders
Eczema	1/29 (3.4%)		0/30 (0%)		0/29 (0%)
Vascular disorders
Arterial occlusive disease	0/29 (0%)		1/30 (3.3%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	BMS-813160 150 mg QD		BMS-813160 300 mg BID		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/29 (10.3%)		2/30 (6.7%)		4/29 (13.8%)
Gastrointestinal disorders
Diarrhoea	1/29 (3.4%)		0/30 (0%)		2/29 (6.9%)
General disorders
Oedema peripheral	1/29 (3.4%)		2/30 (6.7%)		3/29 (10.3%)
Fatigue	3/29 (10.3%)		1/30 (3.3%)		1/29 (3.4%)
Infections and infestations
Urinary Tract Infection	0/29 (0%)		2/30 (6.7%)		0/29 (0%)
Investigations
Blood Creatine Phosphokinase Increased	0/29 (0%)		2/30 (6.7%)		0/29 (0%)
Musculoskeletal and connective tissue disorders
Back pain	2/29 (6.9%)		1/30 (3.3%)		0/29 (0%)
Nervous system disorders
Headache	2/29 (6.9%)		1/30 (3.3%)		0/29 (0%)
Dizziness	2/29 (6.9%)		0/30 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.