Trial · NCT02592798
Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
NCT02592798, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2021-03-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD). Trials, record NCT02592798. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02592798
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Pilot Study to Evaluate the Safety and Efficacy of Abatacept in Adults and Children 6 Years and Older With Excessive Loss of Protein in the Urine Due to Either Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)
- NCT number
- NCT02592798
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Nephrotic Syndrome, Focal Segmental Glomerulosclerosis, Minimal Change Disease
- Interventions
- Abatacept, Normal Saline, D5W
- First posted
- 2015-10-30
- Last updated
- 2021-03-05
- Other registries' IDs
- eudract:2015-005450-36
- Results first posted
- 2021-03-05
- Limitations and caveats
Amendment 02 of the Clinical Protocol (18 April 2018) modified the study design, so that the Double-Blind Period (DB) would not include anymore 2 consecutive periods (DB1 and DB2). However, for transparency and completeness reasons, in the Participant Flow and Adverse Events sections data about DB1 and DB2 are reported separately.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in Renal Response at Day 113 | From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period) | Renal Response is defined as the presence of all the following criteria: PROTEINURIA: Reduction of baseline urine protein/creatinine ratio (UPCR) of \>= 50% and to less than 3. RENAL FUNCTION: No worsening of baseline estimated glomerular filtration rate (eGFR) defined as within normal range if normal at baseline or ≥ 75% baseline value if below normal at baseline. |
| Secondary | Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 113 | From baseline (measured at day 1 of study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period) | |
| Secondary | Mean Change From Baseline in Serum Albumine at Day 113 | From baseline (measured at day 1 of the study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period) | |
| Secondary | Percentage of Participants Achieving Complete Remission at Day 113 | From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period) | Complete Remission is defined as the presence of all the following criteria: PROTEINURIA: Urine protein/creatinine ratio (UPCR) ≤ 0.3. RENAL FUNCTION: No worsening of baseline estimated glomerular filtration rate (eGFR) defined as within normal range if normal at baseline or ≥ 75% baseline value if below normal at baseline. |
| Secondary | Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Adult Participants | From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period | PROMIS was used to capture patient reported outcomes relevant to participants with nephrotic syndrome. Mean change from baseline is reported for the following measurements: Fatigue: Short From (SF) Fatigue v1.0 Adult 8a, composed of 8 questions, each one scored from 1 (Not at all) to 5 (Very much). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome). Pain Interference: SF Pain Interference v1.0 Adult 8a, (measuring how much pain is interfering with daily activities). Composed of 8 questions, each one scored from 1 (Not at all) to 5 (Very much). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome). Physical Function: SF Physical Function v1.2 Adult 8b, composed of 8 questions, each one scored from 1 (Without any difficulty) to 5 (Unable to do). Output presented as Total score, ranging from 8 (most desirable outcome) to 40 (least desirable outcome). |
| Secondary | Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Pediatric Participants | From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period | PROMIS was used to capture patient reported outcomes relevant to participants with nephrotic syndrome. Mean change from baseline is reported for the following measurements: Fatigue: Short From (SF) Fatigue v1.0 Peds 10a, composed of 10 questions, each one scored from 0 (Never) to 4 (Almost Always). Output presented as Total score, ranging from 0 (most desirable outcome) to 40 (least desirable outcome). Pain Interference: SF Pain Interference v1.0 Peds 8a, ( measuring how much pain is interfering with daily activities). Composed of 8 questions, each one scored from 0 (Never) to 4 (Almost always). Output presented as Total score, ranging from 0 (most desirable outcome) to 32 (least desirable outcome). Mobility: SF Physical Function-Mobility v1.0 Peds 8a, composed of 8 questions, each one scored from 0 (Not able to do) to 4 (With no trouble). Output presented as Total score, ranging from 0 (least desirable outcome) to 32 (most desirable outcome). |
| Secondary | Number of Participants Experiencing Adverse Events | From first dose in the indicated period to 56 days following last dose in the indicated period (169 days for the Double-Blind Period, up to 337 days for the Cumulative Abatacept Safety Period) | This outcome describes the number of participants experiencing various types of any grade Adverse Events (AEs). The Cumulative Abatacept Safety Period starts at the time of the first dose of Abatacept (either in the Double-Blind Period or in the Open Label Period) and lasts 56 days after the last dose of Abatacept |
| Secondary | Number of Participants Experiencing Adverse Events of Special Interest | From first dose on day 1 to 56 days following last dose (approximately 330 days) | Number of participants experiencing various types of Adverse Events of interest, including infections, malignancies, autoimmune disorders, and infusional related reactions. |
| Secondary | Percentage of Participants With Positive Antibody Response Relative to Baseline | From baseline (day 1) to 168 days following last dose (up to 15 months). Results at day 113 from first dose, day 56, day 84 and day 168 after last dose are presented | A positive response relative to baseline is defined as a positive response at a post-baseline visit that has a titer value greater than the positive baseline titer value. If the baseline titer is missing or negative, any post-baseline positive titer value is considered a positive response relative to baseline. Immunogenicity response is presented as the total of immunogenicity response for "CTLA4 and possibly Ig" and "Ig and/or Junction Region". |
| Secondary | Minimum Blood Plasma Concentration (Cmin) of Abatacept - Adult Participants | From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113 |
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 | Percentage of Participants in Renal Response at Day 113 | From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period) | All treated participants with available measurements | Percent of Participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 113 | From baseline (measured at day 1 of study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period) | All treated participants with available measurements | mg/mg | MEAN |
| SECONDARY | Mean Change From Baseline in Serum Albumine at Day 113 | From baseline (measured at day 1 of the study) to 113 days following first dose administered in the indicated treatment period (113 days for Double-Blind Period, 226 days for Open Label Period) | All treated participants with available measurements | g/dL | MEAN |
| SECONDARY | Percentage of Participants Achieving Complete Remission at Day 113 | From first dose to 113 days following first dose of the indicated period (113 days for Double-Blind Period, 226 days for Open Label Period) | All treated participants with available measurements | Percent of Participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Adult Participants | From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period | All treated participants with available measurements | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) at Day 113 - Pediatric Participants | From baseline (measured at day 1 of study) to 113 days following first dose administered in the Double-Blind Period | All treated participants with available measurements | Score on a scale | MEAN |
| SECONDARY | Number of Participants Experiencing Adverse Events | From first dose in the indicated period to 56 days following last dose in the indicated period (169 days for the Double-Blind Period, up to 337 days for the Cumulative Abatacept Safety Period) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Experiencing Adverse Events of Special Interest | From first dose on day 1 to 56 days following last dose (approximately 330 days) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Positive Antibody Response Relative to Baseline | From baseline (day 1) to 168 days following last dose (up to 15 months). Results at day 113 from first dose, day 56, day 84 and day 168 after last dose are presented | All treated participants with available measurements | Percent of Participants | NUMBER |
| SECONDARY | Minimum Blood Plasma Concentration (Cmin) of Abatacept - Adult Participants | From first dose to 113 days after first dose in the Double Blind Period. Data collected on day 15, day 29, day 57, day 85 and day 113 | All adult participants receiving Abatacept during the Double Blind Period with available measurements | ug/mL | GEOMETRIC_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in Renal Response at Day 113 | Abatacept | Double-Blind Period Day 113 | 0.0 | 95% Confidence Interval 0.0 to 24.7 | Percent of Participants |
| Percentage of Participants in Renal Response at Day 113 | Placebo | Double-Blind Period Day 113 | 7.7 | 95% Confidence Interval 0.2 to 36.0 | Percent of Participants |
| Percentage of Participants in Renal Response at Day 113 | Abatacept | Open Label Period Day 113 | 12.5 | 95% Confidence Interval 0.3 to 52.7 | Percent of Participants |
| Percentage of Participants in Renal Response at Day 113 | Placebo | Open Label Period Day 113 | 33.3 | 95% Confidence Interval 7.5 to 70.1 | Percent of Participants |
| Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 113 | Abatacept | Double-Blind Period Day 113 | 0.12 | Standard Error 0.5738 | mg/mg |
| Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 113 | Placebo | Double-Blind Period Day 113 | -0.25 | Standard Error 0.7914 | mg/mg |
| Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 113 | Abatacept | Open Label Period Day 113 | 1.98 | Standard Error 1.1598 | mg/mg |
| Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 113 | Placebo | Open Label Period Day 113 | 0.02 | Standard Error 1.3049 | mg/mg |
| Mean Change From Baseline in Serum Albumine at Day 113 | Abatacept | Double-Blind Period Day 113 | 0.08 | Standard Error 0.1016 | g/dL |
| Mean Change From Baseline in Serum Albumine at Day 113 | Placebo | Double-Blind Period Day 113 | -0.05 | Standard Error 0.0892 | g/dL |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Period 1 (DB1) | STARTED | Abatacept | 17 | |
| Double-Blind Period 1 (DB1) | STARTED | Placebo | 19 | |
| Double-Blind Period 1 (DB1) | COMPLETED | Abatacept | 14 | |
| Double-Blind Period 1 (DB1) | COMPLETED | Placebo | 13 | |
| Double-Blind Period 1 (DB1) | NOT COMPLETED | Abatacept | 3 | |
| Double-Blind Period 1 (DB1) | NOT COMPLETED | Placebo | 6 | |
| Transition From DB1 to DB2 | STARTED | Abatacept | 14 | |
| Transition From DB1 to DB2 | STARTED | Placebo | 13 | |
| Transition From DB1 to DB2 | COMPLETED | Abatacept | 11 | |
| Transition From DB1 to DB2 | COMPLETED | Placebo | 11 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events635
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 | Abatacept During Double-Blind Period 1 (DB1) | 0 | 17 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo During Double-Blind Period 1 (DB1) | 0 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Abatacept During Double-Blind Period 2 (DB2) | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo During Double-Blind Period 2 (DB2) | 1 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Abatacept During Open Label Period (OLE) | 1 | 23 | |
| other | Leukopenia | Blood and lymphatic system disorders | Abatacept During Double-Blind Period 1 (DB1) | 0 | 17 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo During Double-Blind Period 1 (DB1) | 0 | 19 | |
| other | Leukopenia | Blood and lymphatic system disorders | Abatacept During Double-Blind Period 2 (DB2) | 0 | 11 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo During Double-Blind Period 2 (DB2) | 1 | 11 | |
| other | Leukopenia | Blood and lymphatic system disorders | Abatacept During Open Label Period (OLE) | 0 | 23 |
1 to 10 of 635Source ClinicalTrials.gov
See all 635 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abatacept During Double-Blind Period 1 (DB1) | 0 | 17 |
| Total, all-cause mortality | Placebo During Double-Blind Period 1 (DB1) | 0 | 19 |
| Total, all-cause mortality | Abatacept During Double-Blind Period 2 (DB2) | 0 | 11 |
| Total, all-cause mortality | Placebo During Double-Blind Period 2 (DB2) | 0 | 11 |
| Total, all-cause mortality | Abatacept During Open Label Period (OLE) | 0 | 23 |
| Total, other adverse events | Abatacept During Double-Blind Period 1 (DB1) | 13 | 17 |
| Total, other adverse events | Placebo During Double-Blind Period 1 (DB1) | 15 | 19 |
| Total, other adverse events | Abatacept During Double-Blind Period 2 (DB2) | 7 | 11 |
| Total, other adverse events | Placebo During Double-Blind Period 2 (DB2) | 8 | 11 |
| Total, other adverse events | Abatacept During Open Label Period (OLE) | 16 | 23 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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.
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