Trial · NCT03158948
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock
NCT03158948, Phase 2, Completed, Inotrem; results first posted 2024-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock. Trials, record NCT03158948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03158948
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock
- NCT number
- NCT03158948
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Inotrem
- Conditions
- Shock, Septic
- Interventions
- Nangibotide 0.3 mg/kg, Placebo, Nangibotide 1 mg/kg, Nangibotide 3 mg/kg
- First posted
- 2017-05-18
- Last updated
- 2024-10-08
- Results first posted
- 2024-10-08
- Limitations and caveats
- None reported.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion | Adverse events experienced until D28 (End of study visit) | Analyses were performed in the Safety Set composed of all randomized patients who received at least any dose of the study drug (nangibotide or placebo). Adverse events: Summary statistics of treatment emergent adverse events (TEAEs). Clinical events, including death, related to severe sepsis and sepsis complications were exempt from SAE reporting, unless the investigator deemed the event to be related to the administration of the study drug. |
| Primary | Systolic Blood Pressure (SBP) | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). | Systolic blood pressure measured by sphygmomanometer at study site. Median SBP at each visit is summarized by treatment group. |
| Primary | Diastolic Blood Pressure (DBP) | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). | Median DBP at each visit is summarized by treatment group. |
| Primary | Median Arterial Pressure (MAP) | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). | MAP at each visit is summarized by treatment group. |
| Primary | Heart Rate | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5). | Median heart rate at each visit is summarized by treatment group. |
| Primary | Temperature | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5). | Median temperature at each visit is summarized by treatment group. |
| Primary | Electrocardiogram | Electrocardiogram was performed each day from D0 (before IMP initiation) to D5 (EOI) and on D28 (EOS). | Abnormal and emergent clinically significant electrocardiogram were summarized for each group. |
| Primary | Anti-Drug Antibodies (ADA Dimer) | Anti-Drug Antibodies test were done at D0, D10 and D28 in all patients. | Anti-Drug Antibodies test was performed for all patients. |
| Primary | Anti-Drug Antibodies (ADA Monomer) | Anti-Drug Antibodies test were measured at D0, D10 and D28. | Anti-Drug Antibodies test was performed for all patients. |
| Secondary | Pharmacokinetic Parameters From the Non-compartmental Analysis: Cmax | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI | As no pharmacokinetic sample was planned just after the loading dose, maximum observed nangibotide plasma concentration (Cmax) was in the same magnitude as steady-state concentration during the maintenance infusion, calculated as the median of the observed pre-dose concentration from day2 onwards up to the last pre-dose concentration available in the study (Cavg). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion | Adverse events experienced until D28 (End of study visit) | Out of 49 patients included in all 4 groups, TEAEs were observed for 45 patients (12 patients experienced TEAEs in MOTREM 1 group, 12 patients experienced TEAEs in MOTREM 2 group, 11 patients experienced TEAEs in MOTREM 3 group and 10 patients experienced TEAEs in placebo group) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Systolic Blood Pressure (SBP) | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). | The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D1, D2, D3, D4, D5 and EOS visit. | mmHg | MEDIAN |
| PRIMARY | Diastolic Blood Pressure (DBP) | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). | The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D1, D2, D3, D4, D5 and EOS visit. | mmHg | MEDIAN |
| PRIMARY | Median Arterial Pressure (MAP) | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28). | The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D1, D2, D3, D4, D5 and EOS visit. | mmHg | MEDIAN |
| PRIMARY | Heart Rate | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5). | The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. systolic blood pressure (mmHg). Diastolic blood pressure (mmHg), mean arterial pressure (mmHg), heart rate (bpm) and temperature i celcius degrees were described at each time when it was available: D0, D1, D2, D3, D4 and D5/EOI visit. | bpm | MEDIAN |
| PRIMARY | Temperature | Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5). | The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D0, D1, D2, D3, D4, D5/EOI visit. | °C | MEDIAN |
| PRIMARY | Electrocardiogram | Electrocardiogram was performed each day from D0 (before IMP initiation) to D5 (EOI) and on D28 (EOS). | Some patients did not perform ECG at some visits | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Anti-Drug Antibodies (ADA Dimer) | Anti-Drug Antibodies test were done at D0, D10 and D28 in all patients. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Anti-Drug Antibodies (ADA Monomer) | Anti-Drug Antibodies test were measured at D0, D10 and D28. | The results are presented for the Day 28. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetic Parameters From the Non-compartmental Analysis: Cmax | Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOI | ng/mL | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group319
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion | Nangibotide 0.3 mg/kg/h | 12 | Participants | ||
| Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion | Nangibotide 1.0 mg/kg/h | 12 | Participants | ||
| Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion | Nangibotide 3.0 mg/kg/h | 11 | Participants | ||
| Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion | Placebo | 10 | Participants | ||
| Systolic Blood Pressure (SBP) | Placebo | D0 | 121.5 | Full Range 87 to 149 | mmHg |
| Systolic Blood Pressure (SBP) | Nangibotide 0.3 mg/kg/h | D0 | 110.0 | Full Range 90 to 133 | mmHg |
| Systolic Blood Pressure (SBP) | Nangibotide 1.0 mg/kg/h | D0 | 121.0 | Full Range 96 to 131 | mmHg |
| Systolic Blood Pressure (SBP) | Nangibotide 3.0 mg/kg/h | D0 | 111.0 | Full Range 87 to 160 | mmHg |
| Systolic Blood Pressure (SBP) | Placebo | D1 | 114.5 | Full Range 82 to 131 | mmHg |
| Systolic Blood Pressure (SBP) | Nangibotide 0.3 mg/kg/h | D1 | 117.0 | Full Range 96 to 159 | mmHg |
1 to 10 of 319Source ClinicalTrials.gov
See all 319 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nangibotide 0.3 mg/kg/h | 13 | |
| Overall Study | STARTED | Nangibotide 1.0 mg/kg/h | 12 | |
| Overall Study | STARTED | Nangibotide 3.0 mg/kg/h | 12 | |
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | COMPLETED | Nangibotide 0.3 mg/kg/h | 12 | |
| Overall Study | COMPLETED | Nangibotide 1.0 mg/kg/h | 11 | |
| Overall Study | COMPLETED | Nangibotide 3.0 mg/kg/h | 9 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | Nangibotide 0.3 mg/kg/h | 1 | |
| Overall Study | NOT COMPLETED | Nangibotide 1.0 mg/kg/h | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events148
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 3 | 12 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Nangibotide 0.3 mg/kg/h | 3 | 13 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Nangibotide 1.0 mg/kg/h | 2 | 12 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Nangibotide 3.0 mg/kg/h | 3 | 12 | 3 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 1 | 12 | 1 |
| other | Atrial fibrillation | Cardiac disorders | Nangibotide 0.3 mg/kg/h | 5 | 13 | 5 |
| other | Atrial fibrillation | Cardiac disorders | Nangibotide 1.0 mg/kg/h | 2 | 12 | 2 |
| other | Atrial fibrillation | Cardiac disorders | Nangibotide 3.0 mg/kg/h | 3 | 12 | 3 |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 12 | 2 |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Nangibotide 0.3 mg/kg/h | 1 | 13 | 1 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 3 | 12 |
| Total, all-cause mortality | Nangibotide 0.3 mg/kg/h | 4 | 13 |
| Total, all-cause mortality | Nangibotide 1.0 mg/kg/h | 2 | 12 |
| Total, all-cause mortality | Nangibotide 3.0 mg/kg/h | 4 | 12 |
| Total, other adverse events | Placebo | 10 | 12 |
| Total, other adverse events | Nangibotide 0.3 mg/kg/h | 12 | 13 |
| Total, other adverse events | Nangibotide 1.0 mg/kg/h | 12 | 12 |
| Total, other adverse events | Nangibotide 3.0 mg/kg/h | 11 | 12 |
| Total, serious adverse events | Placebo | 7 | 12 |
| Total, serious adverse events | Nangibotide 0.3 mg/kg/h | 4 | 13 |
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.
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GET https://conductscience.org/api/trials/v1/NCT03158948/results?page=2