NCT01752985

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

Terminated Phase 2 Results posted Last updated 30 July 2019

What this trial tests

Phase 2 trial testing BMS-813160 in Diabetic Kidney Disease in 319 participants. Terminated before completion.

Timeline

18 March 2013

Primary endpoint
30 June 2015

30 June 2015

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	319
Start date	18 March 2013
Primary completion	30 June 2015
Estimated completion	30 June 2015
Sites	62 locations across Denmark, France, Canada, United States

Drugs / interventions tested

• BMS-813160 — full drug profile →
• Placebo matching with BMS-813160 — full drug profile →

Conditions studied

• Diabetic Kidney Disease — all drugs for Diabetic Kidney Disease →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Eligibility, any sex, with Diabetic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio (UACR) Across 12 Weeks of Treatment With BMS-813160 Primary · 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.

Week 2

Group	Value	95% CI
BMS-813160 150 mg QD	5.78	± 48.994
BMS-813160 300 mg BID	3.79	± 62.795
Placebo	2.05	± 30.771

Week 4

Group	Value	95% CI
BMS-813160 150 mg QD	18.43	± 62.661
BMS-813160 300 mg BID	5.81	± 83.274
Placebo	1.46	± 40.051

Week 8

Group	Value	95% CI
BMS-813160 150 mg QD	19.49	± 65.381
BMS-813160 300 mg BID	9.87	± 56.557
Placebo	5.68	± 43.659

Week 12

Group	Value	95% CI
BMS-813160 150 mg QD	6.91	± 56.666
BMS-813160 300 mg BID	29.16	± 78.69
Placebo	8.91	± 54.025

Week 16

Group	Value	95% CI
BMS-813160 150 mg QD	0.97	± 61.72
BMS-813160 300 mg BID	20.63	± 85.578
Placebo	23.77	± 70.411

Number of Participants With Serious Adverse Events (SAEs), Who Died and With Other (Not Including Serious) Adverse Events Secondary · 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), persiste

SAEs

Group	Value	95% CI
BMS-813160 150 mg QD	3
BMS-813160 300 mg BID	3
Placebo	1

Death

Group	Value	95% CI
BMS-813160 150 mg QD	0
BMS-813160 300 mg BID	1
Placebo	0

Other (Non-Serious) Adverse Events 5 % cut-off

Group	Value	95% CI
BMS-813160 150 mg QD	3
BMS-813160 300 mg BID	2
Placebo	4

Number of Participants With Out-of-Range Electrocardiogram (ECG) Interval Secondary · 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 ventr

PR >200 msec

Group	Value	95% CI
BMS-813160 150 mg QD	8
BMS-813160 300 mg BID	8
Placebo	4

QRS >120 msec

Group	Value	95% CI
BMS-813160 150 mg QD	3
BMS-813160 300 mg BID	3
Placebo	3

QT >500 msec

Group	Value	95% CI
BMS-813160 150 mg QD	0
BMS-813160 300 mg BID	1
Placebo	0

QTcF >450 msec

Group	Value	95% CI
BMS-813160 150 mg QD	7
BMS-813160 300 mg BID	5
Placebo	6

Change from baseline in QT >30 msec

Group	Value	95% CI
BMS-813160 150 mg QD	8
BMS-813160 300 mg BID	6
Placebo	4

Change from baseline in QTcF >30 msec

Group	Value	95% CI
BMS-813160 150 mg QD	4
BMS-813160 300 mg BID	3
Placebo	1

Adverse events — posted to ClinicalTrials.gov

Time frame: From the date of participant's written consent until 30 days post discontinuation of dosing, assessed up to 26 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BMS-813160 150 mg QD

Serious: 3/29 (10%)

Deaths: 0/29

BMS-813160 300 mg BID

Serious: 3/30 (10%)

Deaths: 1/30

Placebo

Serious: 1/29 (3%)

Deaths: 0/29

Serious adverse events (10 terms)

Reaction	System	BMS-813160 150 mg QD	BMS-813160 300 mg BID	Placebo
Arterial occlusive disease	Vascular disorders	—	—	—
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Angina pectoris	Cardiac disorders	—	—	—
Coronary artery occlusion	Cardiac disorders	—	—	—
Angina unstable	Cardiac disorders	—	—	—
Transient ischaemic attack	Nervous system disorders	—	—	—
Death	General disorders	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—
Lobar pneumonia	Infections and infestations	—	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	BMS-813160 150 mg QD	BMS-813160 300 mg BID	Placebo
Oedema peripheral	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Blood Creatine Phosphokinase Increased	Investigations	—	—	—
Headache	Nervous system disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—

Most-reported serious reactions: Arterial occlusive disease, B-cell lymphoma, Angina pectoris, Coronary artery occlusion, Angina unstable, Transient ischaemic attack, Death, Eczema.

Data from ClinicalTrials.gov NCT01752985 adverse events section.

Sponsor's own description

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

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pathogenic Pathways and Therapeutic Approaches Targeting Inflammation in Diabetic Nephropathy.
   Rayego-Mateos S, Morgado-Pascual JL, Opazo-Ríos L, Guerrero-Hue M, et al · · 2020 · cited 237× · PMID 32471207 · DOI 10.3390/ijms21113798
2. Targeting the CCL2/CCR2 Axis in Cancer Immunotherapy: One Stone, Three Birds?
   Fei L, Ren X, Yu H, Zhan Y. · · 2021 · cited 172× · PMID 34804061 · DOI 10.3389/fimmu.2021.771210
3. Twenty years after ACEIs and ARBs: emerging treatment strategies for diabetic nephropathy.
   Johnson SA, Spurney RF. · · 2015 · cited 53× · PMID 26336162 · DOI 10.1152/ajprenal.00266.2015
4. Horizon 2020 in Diabetic Kidney Disease: The Clinical Trial Pipeline for Add-On Therapies on Top of Renin Angiotensin System Blockade.
   Perez-Gomez MV, Sanchez-Niño MD, Sanz AB, Martín-Cleary C, et al · · 2015 · cited 51× · PMID 26239562 · DOI 10.3390/jcm4061325
5. A panel of novel biomarkers representing different disease pathways improves prediction of renal function decline in type 2 diabetes.
   Pena MJ, Heinzel A, Heinze G, Alkhalaf A, et al · · 2015 · cited 50× · PMID 25973922 · DOI 10.1371/journal.pone.0120995
6. Potentials of C-C motif chemokine 2-C-C chemokine receptor type 2 blockers including propagermanium as anticancer agents.
   Yumimoto K, Sugiyama S, Mimori K, Nakayama KI. · · 2019 · cited 35× · PMID 31111571 · DOI 10.1111/cas.14075
7. Common Drug Pipelines for the Treatment of Diabetic Nephropathy and Hepatopathy: Can We Kill Two Birds with One Stone?
   Sumida Y, Yoneda M, Toyoda H, Yasuda S, et al · · 2020 · cited 10× · PMID 32668632 · DOI 10.3390/ijms21144939