Trial · NCT01788631
A Phase II Trial of Regadenoson in Sickle Cell Anemia
NCT01788631, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2018-02-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II Trial of Regadenoson in Sickle Cell Anemia. Trials, record NCT01788631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01788631
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase II Trial of Regadenoson in Sickle Cell Anemia
- NCT number
- NCT01788631
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Sickle Cell Anemia
- Interventions
- Regadenoson, Placebo
- First posted
- 2013-02-11
- Last updated
- 2018-02-07
- Results first posted
- 2018-02-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Reduction in Invariant Natural-Killer T-Cell (iNKT Cell) Activation by 70% or More | Baseline-End of study infusion over 48 hours | To determine if infusional Regadenoson reduced iNKT cell activation among individuals with sickle cell anemia (SCA) and pain or acute chest syndrome (ACS) compared to placebo by 70% or greater. |
| Secondary | Length of Hospital Stay | Hospital Presentation- Hospital Discharge, assessed up to 1 month | To determine if regadenoson reduces length of hospital stay among individuals admitted with SCA and pain or ACS compared to placebo |
| Secondary | Number of Participants With an Improvement in Respiratory Symptoms | Baseline-End of study infusion over 48 hours | To determine if regadenoson improved respiratory symptoms among individuals with sickle cell anemia (SCA) and pain or acute chest syndrome (ACS) compared to placebo. Patients were classified as having an improvement in respiratory symptoms if they experienced any of the following outcomes:(1) respiratory rate decreased by 25% from baseline or normalized (≤20 bpm) or (2) degree of hypoxia (SpO2) on room air increased by 10% from baseline or normalized (≥92%) or (3) thoracic pain improved by 3 points from baseline on a 10-point visual analog scale. |
| Secondary | Opioid Use | Baseline-End of study infusion over 48 hours | To determine if regadenoson reduces opioid use among individuals with SCA and pain or ACS compared to placebo. |
| Secondary | Level of Inflammatory Markers (A2A) | Baseline-End of study infusion over 48 hours | To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo. |
| Secondary | Level of Inflammatory Markers (IL-4) | Baseline-End of study infusion over 48 hours | To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo. |
| Secondary | Level of Inflammatory Markers (IFN-gamma) | Baseline-End of study infusion over 48 hours | To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With a Reduction in Invariant Natural-Killer T-Cell (iNKT Cell) Activation by 70% or More | Baseline-End of study infusion over 48 hours | Treated patients with baseline and end of infusion blood samples. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Length of Hospital Stay | Hospital Presentation- Hospital Discharge, assessed up to 1 month | All patients who had baseline and end of infusion blood samples. | Days | MEDIAN |
| SECONDARY | Number of Participants With an Improvement in Respiratory Symptoms | Baseline-End of study infusion over 48 hours | All patients who had baseline and end of infusion blood samples. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Opioid Use | Baseline-End of study infusion over 48 hours | All patients who had baseline and end of infusion blood samples. | mg/kg/hr | MEDIAN |
| SECONDARY | Level of Inflammatory Markers (A2A) | Baseline-End of study infusion over 48 hours | All patients who had baseline and end of infusion blood samples. | A2A levels as percent of baseline | MEDIAN |
| SECONDARY | Level of Inflammatory Markers (IL-4) | Baseline-End of study infusion over 48 hours | All patients who had baseline and end of infusion blood samples. | IL-4 levels as percent of baseline | MEDIAN |
| SECONDARY | Level of Inflammatory Markers (IFN-gamma) | Baseline-End of study infusion over 48 hours | All patients who had baseline and end of treatment samples | IFN-gamma levels as percent of baseline | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Reduction in Invariant Natural-Killer T-Cell (iNKT Cell) Activation by 70% or More | Regadenoson Arm | 21 | Participants | ||
| Number of Participants With a Reduction in Invariant Natural-Killer T-Cell (iNKT Cell) Activation by 70% or More | Placebo Arm | 10 | Participants | ||
| Length of Hospital Stay | Regadenoson Arm | 3.96 | Full Range 2.23 to 19.25 | Days | |
| Length of Hospital Stay | Placebo Arm | 3.99 | Full Range 2.34 to 30.40 | Days | |
| Number of Participants With an Improvement in Respiratory Symptoms | Regadenoson Arm | 10 | Participants | ||
| Number of Participants With an Improvement in Respiratory Symptoms | Placebo Arm | 9 | Participants | ||
| Opioid Use | Regadenoson Arm | 0.03 | Full Range 0.00 to 0.50 | mg/kg/hr | |
| Opioid Use | Placebo Arm | 0.04 | Full Range 0.00 to 0.36 | mg/kg/hr | |
| Level of Inflammatory Markers (A2A) | Regadenoson Arm | 86.39 | Full Range 35.3 to 316.67 | A2A levels as percent of baseline | |
| Level of Inflammatory Markers (A2A) | Placebo Arm | 100.95 | Full Range 17.44 to 404.66 | A2A levels as percent of baseline |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regadenoson Arm | 52 | |
| Overall Study | STARTED | Placebo Arm | 44 | |
| Overall Study | Randomized | Regadenoson Arm | 53 | |
| Overall Study | Randomized | Placebo Arm | 47 | |
| Overall Study | COMPLETED | Regadenoson Arm | 49 | |
| Overall Study | COMPLETED | Placebo Arm | 43 | |
| Overall Study | NOT COMPLETED | Regadenoson Arm | 3 | |
| Overall Study | NOT COMPLETED | Placebo Arm | 1 |
Source ClinicalTrials.gov
Adverse events198
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 | Abdominal pain | Gastrointestinal disorders | Regadenoson Arm | 1 | 52 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Arm | 4 | 44 | |
| other | Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Regadenoson Arm | 0 | 52 | |
| other | Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Placebo Arm | 1 | 44 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Regadenoson Arm | 1 | 52 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Placebo Arm | 2 | 44 | |
| other | Anemia | Blood and lymphatic system disorders | Regadenoson Arm | 4 | 52 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo Arm | 5 | 44 | |
| other | Anorexia | Metabolism and nutrition disorders | Regadenoson Arm | 2 | 52 | |
| other | Anorexia | Metabolism and nutrition disorders | Placebo Arm | 1 | 44 |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regadenoson Arm | 0 | 52 |
| Total, all-cause mortality | Placebo Arm | 0 | 44 |
| Total, other adverse events | Regadenoson Arm | 44 | 52 |
| Total, other adverse events | Placebo Arm | 35 | 44 |
| Total, serious adverse events | Regadenoson Arm | 14 | 52 |
| Total, serious adverse events | Placebo Arm | 16 | 44 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29296811 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| P50HL110790 | A Controlled Clinical Trial of Regadenoson in Sickle Cell Anemia | NATHAN, DAVID G.; FIELD, JOSHUA JEFFREY; LINDEN, JOEL M.; NEUBERG, DONNA S. | DANA-FARBER CANCER INST | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2012 to 2016 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Regadenoson Arm vs Placebo Arm: Number of Participants With an Improvement in Respiratory Symptoms | Trial comparisons |
| Regadenoson Arm vs Placebo Arm: Number of Participants With a Reduction in Invariant Natural-Killer T-Cell (iNKT Cell) Activation by 70% or More | Trial comparisons |
| Regadenoson Arm vs Placebo Arm: deaths from any cause | Trial comparisons |
| Regadenoson Arm vs Placebo Arm: 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/NCT01788631
GET https://conductscience.org/api/trials/v1/NCT01788631/events?page=2