Trial · NCT02000440
A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS)
NCT02000440, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-06-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS). Trials, record NCT02000440. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02000440
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS)
- NCT number
- NCT02000440
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Glomerulosclerosis, Focal Segmental
- Interventions
- Losmapimod
- First posted
- 2013-12-04
- Last updated
- 2017-06-12
- Results first posted
- 2017-06-12
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at the Indicated Time Points | Week 2, Week 4, Week 8, Week 16 and Week 24 | Proteinuria is defined as the presence of an excess of serum proteins in the urine. Participant was considered as a responder on achieving \>=50 percent reduction in proteinuria from Baseline (measured as 24 hour total protein) and also having a stable renal function of \>=70 percent of Baseline estimated glomerular filtration rate (eGFR) at end of treatment (\>=16 Weeks). Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Secondary | Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at Any Time During the Treatment Phase (Week 2 to Week 24) | Any time during the treatment phase (Week 2 to Week 24) | Proteinuria is defined as the presence of an excess of serum proteins in the urine. Participant was considered as responder on achieving \>=50 percent reduction in proteinuria from Baseline (measured as 24 hour total protein) and also having a stable renal function of \>=70 percent of Baseline eGFR at any time during the treatment phase of the study. Reduction in proteinuria assessment at any time during the treatment phase of the study was done by utilizing a responder analysis. |
| Secondary | Percent Change From Baseline in Urinary Protein/Creatinine (Up/c) Ratio (Spot and 24 Hours [hr]) | Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, Week 30 and Week 36 | Reduction in proteinuria was measured by the Up/c ratio (spot and 24 hr) at Baseline, Week 2, 4, 8, 16, 24, end of study and at Follow-up (FU) visits Week 30 and 36. Spot urine sample was provided by the participants on site. The 24 hour urine collection started with the second morning void and ended with the first morning void on the following day; generally, 24 hour urine collection was initiated the day prior to the study visit. Baseline was defined as the value obtained at Week 0. Percent change from Baseline was calculated as change from Baseline value divided by Baseline value multiplied by 100. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Secondary | Number of Participants With Complete Proteinuria Remissions at the Indicated Time Points | Week 2, Week 4, Week 8, Week 16 and Week 24 | Incidence of complete remissions at any time point was defined as 24 hour total protein \<0.3 gram (g) per Day and maintenance of \>=70 percent of Baseline eGFR throughout the treatment period. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed. |
| Secondary | Number of Participants Having Any Adverse Events (AEs), Serious Adverse Events (SAEs) | From start of the study treatment (Week 0) until the Follow-up phase (Week 36) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE were included in the analysis. |
| Secondary | Number of Participants Withdrawn Due to Toxicities | From start of the study treatment (Week 0) until the Follow-up phase (Week 36) | Participants were monitored from start of the study treatment (Week 0) up to Week 36 for development of toxicity. Participants who developed toxicity during the period were to be withdrawn from the study. |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36) | Blood pressure was measured in a sitting position after 5 minutes rest with comfortably seated, legs uncrossed and the back and arm supported, such that the middle of the cuff on the upper arm is at the level of the right atrium and asked to remove all clothing that covered the location of cuff placement. It was recorded at Screening, Baseline, Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36). Vital sign measurements were repeated if the values were \< 80 mmHg or \> 140 mmHg SBP and \<40 mmHg or \>90 mmHg for DBP. Baseline was defined as the value obtained on Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Secondary | Change From Baseline in Heart Rate at Indicated Time Points | Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36) | Heart rate was measured at screening, Baseline and throughout the treatment phase (Week 24) and Follow-up phase (Week 36). Heart rate measurement was repeated if the values are calculated \<50 beats per minute. (bpm) or \>110 bpm after the start of dosing. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Secondary | Change From Baseline in Liver Function Parameters: Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) at Indicated Time Points | Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36) | Blood samples were collected at Screening (Week -4 and -2), Baseline (Week 0) and at Weeks 2, 4, 8, 16, 24 and Follow-up (Week 30 and 36) to evaluate ALT, AST, AP and GGT. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
| Secondary | Change From Baseline in Liver Function Parameters: Direct Bilirubin and Total Bilirubin at Indicated Time Points | Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36) | Clinical chemistry parameters: direct bilirubin and total bilirubin were assessed at Baseline (Week 0) and at Weeks 2, 4, 8, 16 24, End of studyand Follow-up (Week 30 and 36) phase. Baseline was defined as the value obtained at Week 0. Change from Baseline was calculated as visit value minus value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at the Indicated Time Points | Week 2, Week 4, Week 8, Week 16 and Week 24 | Completed Treatment Population: comprised of participants who had completed \>=16 weeks of losmapimod treatment or who withdrew from the treatment. Participants who withdrew prior to Week 16 were considered as non-responders. | Participants | NUMBER |
| SECONDARY | Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at Any Time During the Treatment Phase (Week 2 to Week 24) | Any time during the treatment phase (Week 2 to Week 24) | Completed Treatment Population | Participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Urinary Protein/Creatinine (Up/c) Ratio (Spot and 24 Hours [hr]) | Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, Week 30 and Week 36 | All Subject Population: all eligible participants who received at least one dose of investigational drug. | Percent change | MEAN |
| SECONDARY | Number of Participants With Complete Proteinuria Remissions at the Indicated Time Points | Week 2, Week 4, Week 8, Week 16 and Week 24 | Completed Treatment Population | Participants | NUMBER |
| SECONDARY | Number of Participants Having Any Adverse Events (AEs), Serious Adverse Events (SAEs) | From start of the study treatment (Week 0) until the Follow-up phase (Week 36) | All Subject Population | Participants | NUMBER |
| SECONDARY | Number of Participants Withdrawn Due to Toxicities | From start of the study treatment (Week 0) until the Follow-up phase (Week 36) | All Subject Population | Participants | NUMBER |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36) | All Subject Population | Millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Heart Rate at Indicated Time Points | Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36) | All Subject Population | bpm | MEAN |
| SECONDARY | Change From Baseline in Liver Function Parameters: Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma Glutamyl Transferase (GGT) at Indicated Time Points | Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36) | All Subject Population | International Units/liter (IU/L) | MEAN |
| SECONDARY | Change From Baseline in Liver Function Parameters: Direct Bilirubin and Total Bilirubin at Indicated Time Points | Baseline (Week 0), Week 2, Week 4, Week 8, Week 16, Week 24, End of study, and until the follow-up visit (Week 30 and Week 36) | All Subject Population | Micromoles per liter (umol/L) | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at the Indicated Time Points | Losmapimod 7.5 mg BID / 15 mg BID | Week 2, n= 17 | 0 | Participants | |
| Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at the Indicated Time Points | Losmapimod 7.5 mg BID / 15 mg BID | Week 4, n=15 | 1 | Participants | |
| Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at the Indicated Time Points | Losmapimod 7.5 mg BID / 15 mg BID | Week 8, n=15 | 0 | Participants | |
| Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at the Indicated Time Points | Losmapimod 7.5 mg BID / 15 mg BID | Week 16, n=13 | 0 | Participants | |
| Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at the Indicated Time Points | Losmapimod 7.5 mg BID / 15 mg BID | Week 24, n=13 | 0 | Participants | |
| Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at Any Time During the Treatment Phase (Week 2 to Week 24) | Losmapimod 7.5 mg BID / 15 mg BID | 1 | Participants | ||
| Percent Change From Baseline in Urinary Protein/Creatinine (Up/c) Ratio (Spot and 24 Hours [hr]) | Losmapimod 7.5 mg BID / 15 mg BID | Up/c ratio 24 hr, Week 2, n= 17 | -0.45807 | Standard Deviation 25.696890 | Percent change |
| Percent Change From Baseline in Urinary Protein/Creatinine (Up/c) Ratio (Spot and 24 Hours [hr]) | Losmapimod 7.5 mg BID / 15 mg BID | Up/c ratio 24 hr, Week 4, n= 15 | -0.07037 | Standard Deviation 28.954312 | Percent change |
| Percent Change From Baseline in Urinary Protein/Creatinine (Up/c) Ratio (Spot and 24 Hours [hr]) | Losmapimod 7.5 mg BID / 15 mg BID | Up/c ratio 24 hr, Week 8, n= 15 | 24.32547 | Standard Deviation 39.925052 | Percent change |
| Percent Change From Baseline in Urinary Protein/Creatinine (Up/c) Ratio (Spot and 24 Hours [hr]) | Losmapimod 7.5 mg BID / 15 mg BID | Up/c ratio 24 hr, Week 16, n= 13 | -10.57111 | Standard Deviation 37.211084 | Percent change |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Losmapimod 7.5 mg BID / 15 mg BID | 17 | |
| Overall Study | COMPLETED | Losmapimod 7.5 mg BID / 15 mg BID | 13 | |
| Overall Study | NOT COMPLETED | Losmapimod 7.5 mg BID / 15 mg BID | 4 |
Source ClinicalTrials.gov
Adverse events59
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 | Nausea | Gastrointestinal disorders | Losmapimod 7.5 mg BID / 15 mg BID | 3 | 17 | |
| other | Vomiting | Gastrointestinal disorders | Losmapimod 7.5 mg BID / 15 mg BID | 3 | 17 | |
| other | Abdominal pain | Gastrointestinal disorders | Losmapimod 7.5 mg BID / 15 mg BID | 2 | 17 | |
| other | Dyspepsia | Gastrointestinal disorders | Losmapimod 7.5 mg BID / 15 mg BID | 2 | 17 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Losmapimod 7.5 mg BID / 15 mg BID | 1 | 17 | |
| other | Diarrhoea | Gastrointestinal disorders | Losmapimod 7.5 mg BID / 15 mg BID | 1 | 17 | |
| other | Flatulence | Gastrointestinal disorders | Losmapimod 7.5 mg BID / 15 mg BID | 1 | 17 | |
| other | Headache | Nervous system disorders | Losmapimod 7.5 mg BID / 15 mg BID | 5 | 17 | |
| other | Dizziness | Nervous system disorders | Losmapimod 7.5 mg BID / 15 mg BID | 3 | 17 | |
| other | Dizziness postural | Nervous system disorders | Losmapimod 7.5 mg BID / 15 mg BID | 1 | 17 |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Losmapimod 7.5 mg BID / 15 mg BID | ||
| Total, other adverse events | Losmapimod 7.5 mg BID / 15 mg BID | 16 | 17 |
| Total, serious adverse events | Losmapimod 7.5 mg BID / 15 mg BID | 0 | 17 |
Source ClinicalTrials.gov
Papers0
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/NCT02000440
GET https://conductscience.org/api/trials/v1/NCT02000440/results?page=2