Trial · NCT03000673
A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis
NCT03000673, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2020-12-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis. Trials, record NCT03000673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03000673
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis
- NCT number
- NCT03000673
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Antithrombotic
- Interventions
- Enoxaparin, unfractionated heparin (UFH), BMS-986177
- First posted
- 2016-12-22
- Last updated
- 2020-12-29
- Results first posted
- 2020-12-29
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017) | Safety and tolerability of single oral doses of BMS-986177 in patients with end-stage renal disease (ESRD) on chronic hemodialysis (HD) treatment as measured by the number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation and death |
| Primary | The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW \< 0.85\*PRE-RX; HEMATOCRIT HCT % LOW \< 0.85\*PRE-RX; PLATELET COUNT PLAT X10\*9 C/L LOW \< 0.85\*LLN IF PRE-RX IS MISSING; \< 0.85\*LLN IF PRE-RX \>= LLN; \< 0.85\*PRE-RX IF PRE-RX \< LLN; HIGH \> 1.5\*ULN; HEMATOLOGY II; LEUKOCYTES WBC X10\*3 C/UL LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF LLN \<= PRE-RX \<= ULN; \< 0.85\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.2\*ULN IF PRE-RX IS MISSING; \> 1.2\*ULN IF LLN \<= PRE-RX \<= ULN; \> 1.5\*PRE-RX IF PRE-RX \> ULN; NEUTROPHILS (ABSOLUTE) NEUTA X10\*3 C/UL LOW \< 1.5 IF PRE-RX IS MISSING; \< 1.5 IF PRE-RX \>= 1.5; \< 0.85\*PRE-RX IF; PRE-RX \< 1.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10\*3 C/UL LOW \< 0.75; HIGH \> 7.5; MONOCYTES (ABSOLUTE) MONOA X10\*3 C/UL HIGH \> 2; BASOPHILS (ABSOLUTE) BASOA X10\*3 C/UL HIGH \> 0.4; EOSINOPHILS (ABSOLUTE) EOSA X10\*3 C/UL HIGH \> 0.75; COAGULATION: PROTHROMBIN TIME (PT) PT SEC HIGH \> 1.5\*ULN; APTT APTT SEC HIGH \> 1.5\*ULN; INTL NORMALIZED RATIO (INR) INR FRACTION HIGH \> 1.5\*ULN; |
| Primary | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | LIVER \& KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH \> 1.25\*ULN IF PRE-RX IS MISSING; \> 1.25\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L HIGH \> 1.25\*ULN IF PRE-RX IS MISSING; \> 1.25\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L HIGH \> 1.25\*ULN IF PRE-RX IS MISSING; \> 1.25\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; BILIRUBIN, TOTAL TBILI MG/DL HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; BILIRUBIN, DIRECT DBILI MG/DL HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; BLOOD UREA NITROGEN BUN MG/DL HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.2\*PRE-RX IF PRE-RX \> ULN; CREATININE CREAT MG/DL HIGH \> 1.5\*ULN IF PRE-RX IS MISSING; \> 1.5\*ULN IF PRE-RX \<= ULN; \> 1.33\*PRE-RX IF PRE-RX \> ULN; |
| Primary | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge | ELECTROLYTES: SODIUM, SERUM NA MEQ/L LOW \< 0.95\*LLN IF PRE-RX IS MISSING; \< 0.95\*LLN IF PRE-RX \>= LLN; \< 0.95\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.05\*ULN IF PRE-RX IS MISSING; \> 1.05\*ULN IF PRE-RX \<= ULN; \> 1.05\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; POTASSIUM, SERUM K MEQ/L LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.1\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; CHLORIDE, SERUM CL MEQ/L LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.1\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; |
| Primary | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.) | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | ELECTROLYTES (CONT.): CALCIUM, TOTAL CA MG/DL LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.1\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; PHOSPHORUS, INORGANIC PHOS MG/DL LOW \< 0.85\*LLN IF PRE-RX IS MISSING; \< 0.85\*LLN IF PRE-RX \>= LLN; \< 0.85\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.25\*ULN IF PRE-RX IS MISSING; \> 1.25\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; MAGNESIUM, SERUM MG MEQ/L LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.1\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN |
| Primary | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | GLUCOSE, FASTING SERUM GLUCF MG/DL LOW \< 0.8\*LLN IF PRE-RX IS MISSING; \< 0.8\*LLN IF PRE-RX \>= LLN; \< 0.8\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN; HIGH \> 1.3\*ULN IF PRE-RX IS MISSING \> 1.3\*ULN IF PRE-RX \<= ULN; \> 2\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; PROTEIN, TOTAL TPRO G/DL LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; \< LLN IF PRE-RX \> ULN HIGH \> 1.1\*ULN IF PRE-RX IS MISSING; \> 1.1\*ULN IF PRE-RX \<= ULN; \> 1.1\*PRE-RX IF PRE-RX \> ULN; \> ULN IF PRE-RX \< LLN; ALBUMIN ALB G/DL LOW \< 0.9\*LLN IF PRE-RX IS MISSING; \< 0.9\*LLN IF PRE-RX \>= LLN; \< 0.9\*PRE-RX IF PRE-RX \< LLN; CREATINE KINASE (CK) CK U/L HIGH \> 1.5\*ULN IF PRE-RX IS MISSING; \> 1.5\*ULN IF PRE-RX \<= ULN; \> 1.5\*PRE-RX IF PRE-RX \> ULN; URIC ACID URIC MG/DL HIGH \> 1.2\*ULN IF PRE-RX IS MISSING; \> 1.2\*ULN IF PRE-RX \<= ULN; \> 1.25\*PRE-RX IF PRE-RX \> ULN; LACTATE DEHYDR (LD) LD U/L HIGH \> 1.25\*ULN IF PRE-RX IS MISSING; \> 1.25\*ULN IF PRE-RX \<= ULN; \> 1.5\*PRE-RX IF PRE-RX \> ULN |
| Primary | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | URINALYSIS I; BLOOD, URINE UBLD N/A HIGH \>= 2 IF PRE-RX IS MISSING; \>= 2 IF PRE-RX \< 1; \>= 2 IF PRE-RX \>= 1 SPECIAL STUDIES; OCCULT BLOOD SCREEN, FECES OCBLD N/A HIGH NEGATIVE PRE-RX CHANGING TO POSITIVE |
| Primary | The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate | Days -3 to -1, Days 1, 5, 8, and 12. | Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. |
| Primary | The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate | Days -3 to -1, Days 1, 5, 8, and 12. | Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. |
| Primary | The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate | Days -3 to -1, Days 1, 5, 8, and 12. | Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017) | All treated participants | Participants | NUMBER |
| PRIMARY | The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.) | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies | At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge. | All treated participants with evaluable test results | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate | Days -3 to -1, Days 1, 5, 8, and 12. | All treated participants | Beats/min | MEAN |
| PRIMARY | The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate | Days -3 to -1, Days 1, 5, 8, and 12. | All treated participants | msec | MEAN |
| PRIMARY | The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate | Days -3 to -1, Days 1, 5, 8, and 12. | All treated participants | msec | MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group340
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | Treatment B | Adverse Events | 4 | Participants | |
| The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | Treatment C | Adverse Events | 4 | Participants | |
| The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | Treatment D | Adverse Events | 3 | Participants | |
| The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | Treatment A | Adverse Events | 2 | Participants | |
| The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | Treatment B | Serious Adverse Events | 0 | Participants | |
| The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | Treatment C | Serious Adverse Events | 0 | Participants | |
| The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | Treatment D | Serious Adverse Events | 0 | Participants | |
| The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | Treatment A | Serious Adverse Events | 0 | Participants | |
| The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | Treatment B | Adverse Events Leading to Discontinuations | 0 | Participants | |
| The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death | Treatment C | Adverse Events Leading to Discontinuations | 0 | Participants |
1 to 10 of 340Source ClinicalTrials.gov
See all 340 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence ABCD | 7 | |
| Overall Study | STARTED | Sequence BDAC | 9 | |
| Overall Study | STARTED | Sequence CADB | 7 | |
| Overall Study | STARTED | Sequence DCBA | 9 | |
| Overall Study | COMPLETED | Sequence ABCD | 6 | |
| Overall Study | COMPLETED | Sequence BDAC | 9 | |
| Overall Study | COMPLETED | Sequence CADB | 7 | |
| Overall Study | COMPLETED | Sequence DCBA | 9 | |
| Overall Study | NOT COMPLETED | Sequence ABCD | 1 | |
| Overall Study | NOT COMPLETED | Sequence BDAC | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment A | 0 | 32 |
| Total, all-cause mortality | Treatment B | 0 | 32 |
| Total, all-cause mortality | Treatment C | 0 | 31 |
| Total, all-cause mortality | Treatment D | 0 | 31 |
| Total, other adverse events | Treatment A | 0 | 32 |
| Total, other adverse events | Treatment B | 0 | 32 |
| Total, other adverse events | Treatment C | 0 | 31 |
| Total, other adverse events | Treatment D | 0 | 31 |
| Total, serious adverse events | Treatment A | 0 | 32 |
| Total, serious adverse events | Treatment B | 0 | 32 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03000673
GET https://conductscience.org/api/trials/v1/NCT03000673/registered?page=2