Trial · NCT04017936
Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis
NCT04017936, Phase 2, Completed, Virginia Commonwealth University; results first posted 2025-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis. Trials, record NCT04017936. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04017936
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis
- NCT number
- NCT04017936
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Cardiac Sarcoidosis
- Interventions
- Anakinra
- First posted
- 2019-07-12
- Last updated
- 2025-08-07
- Results first posted
- 2025-08-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Inflammation Marker | Baseline to 28 days | Change in c-reactive protein in participant plasma samples |
| Secondary | Change in Cardiac Fibrosis | Baseline to 180 days | Change in late gadolinium enhancement evident on magnetic resonance imaging (MRI) scan |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Inflammation Marker | Baseline to 28 days | Patient 5 excluded from Anakinra group outcome analysis. | mg/L | MEAN |
| SECONDARY | Change in Cardiac Fibrosis | Baseline to 180 days | Reported as percent change of relative enhanced late gadolinium enhancement volume (%) | percentage change | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Inflammation Marker | Anakinra | -43 | Standard Deviation 36 | mg/L | |
| Change in Inflammation Marker | Standard of Care | 7 | Standard Deviation 41.56 | mg/L | |
| Change in Cardiac Fibrosis | Anakinra | 17.7 | Standard Deviation 14.7 | percentage change | |
| Change in Cardiac Fibrosis | Standard of Care | 12.3 | Standard Deviation 13.3 | percentage change |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anakinra | 7 | |
| Overall Study | STARTED | Standard of Care | 10 | |
| Overall Study | COMPLETED | Anakinra | 7 | |
| Overall Study | COMPLETED | Standard of Care | 10 | |
| Overall Study | NOT COMPLETED | Anakinra | 0 | |
| Overall Study | NOT COMPLETED | Standard of Care | 0 |
Source ClinicalTrials.gov
Adverse events28
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 | Serious Infection | Infections and infestations | Anakinra | 1 | 7 | 1 |
| other | Serious Infection | Infections and infestations | Standard of Care | 1 | 10 | 1 |
| other | Injection site reaction | Skin and subcutaneous tissue disorders | Anakinra | 3 | 7 | 3 |
| other | Injection site reaction | Skin and subcutaneous tissue disorders | Standard of Care | 3 | 10 | 3 |
| other | Bronchitis | Infections and infestations | Anakinra | 2 | 7 | 2 |
| other | Bronchitis | Infections and infestations | Standard of Care | 0 | 10 | 0 |
| other | Atrial Fibrillation | Cardiac disorders | Anakinra | 1 | 7 | 1 |
| other | Atrial Fibrillation | Cardiac disorders | Standard of Care | 0 | 10 | 0 |
| other | Recurrent atrial tachycardia | Cardiac disorders | Anakinra | 1 | 7 | 1 |
| other | Recurrent atrial tachycardia | Cardiac disorders | Standard of Care | 0 | 10 | 0 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anakinra | 0 | 7 |
| Total, all-cause mortality | Standard of Care | 0 | 10 |
| Total, other adverse events | Anakinra | 7 | 7 |
| Total, other adverse events | Standard of Care | 9 | 10 |
| Total, serious adverse events | Anakinra | 1 | 7 |
| Total, serious adverse events | Standard of Care | 0 | 10 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21TR003103 | Feasibility and Safety of Interleukin-1 Blockade to Treat Cardiac Sarcoidosis | KRON, JORDANA; ABBATE, ANTONIO | VIRGINIA COMMONWEALTH UNIVERSITY | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2020 to 2021 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Anakinra vs Standard of Care: deaths from any cause | Trial comparisons |
| Anakinra vs Standard of Care: serious adverse events | Trial comparisons |
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/NCT04017936
GET https://conductscience.org/api/trials/v1/NCT04017936/events?page=2