ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase II Trial of Regadenoson in Sickle Cell Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01788631
Recruitment Status : Completed
First Posted : February 11, 2013
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
Brigham and Women's Hospital
Boston Children’s Hospital
La Jolla Institute for Allergy & Immunology
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Children's Hospital Medical Center, Cincinnati
University of Illinois at Chicago
Medical College of Wisconsin
Duke University
Johns Hopkins University
Wayne State University
Baylor College of Medicine
Children's Hospital & Research Center Oakland
Information provided by (Responsible Party):
David G. Nathan, MD, Dana-Farber Cancer Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Sickle Cell Anemia
Interventions: Drug: Regadenoson
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between July 2013 and November 2016, 4,940 hospital admissions were screened to enroll 100 study subjects. Patients were recruited at the time of sickle cell vaso-occlusive crises in outpatient clinics, emergency departments, and inpatient units.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to study arm randomization and assignment, patients were screened using the following testing methods: Confirmation of sickle cell genotype, complete blood count with differential, chemistry, coagulation testing (Including PTT, and INR), and pregnancy testing for female participants.

Reporting Groups
  Description
Regadenoson Arm

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo Arm

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.


Participant Flow:   Overall Study
    Regadenoson Arm   Placebo Arm
STARTED   52   44 
Randomized   53   47 
COMPLETED   49   43 
NOT COMPLETED   3   1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled patients.

Reporting Groups
  Description
Regadenoson Arm

1.44 mcg/kg/hour infused over 48 hours

Regadenoson: Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.

Placebo Arm

Placebo infused over 48 hours

Placebo: This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.

Total Total of all reporting groups

Baseline Measures
   Regadenoson Arm   Placebo Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   47   100 
Age 
[Units: Years]
Median (Full Range)
 25 
 (10 to 54) 
 26 
 (13 to 56) 
 25 
 (10 to 56) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   22   24   46 
Male   31   23   54 
Region of Enrollment 
[Units: Participants]
     
United States   53   47   100 


  Outcome Measures

1.  Primary:   Number of Participants With a Reduction in Invariant Natural-Killer T-Cell (iNKT Cell) Activation by 70% or More   [ Time Frame: Baseline-End of study infusion over 48 hours ]

2.  Secondary:   Length of Hospital Stay   [ Time Frame: Hospital Presentation- Hospital Discharge, assessed up to 1 month ]

3.  Secondary:   Number of Participants With an Improvement in Respiratory Symptoms   [ Time Frame: Baseline-End of study infusion over 48 hours ]

4.  Secondary:   Opioid Use   [ Time Frame: Baseline-End of study infusion over 48 hours ]

5.  Secondary:   Level of Inflammatory Markers (A2A)   [ Time Frame: Baseline-End of study infusion over 48 hours ]

6.  Secondary:   Level of Inflammatory Markers (IL-4)   [ Time Frame: Baseline-End of study infusion over 48 hours ]

7.  Secondary:   Level of Inflammatory Markers (IFN-gamma)   [ Time Frame: Baseline-End of study infusion over 48 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. David G. Nathan
Organization: Dana-Farber Cancer Institute
phone: 61746322155
e-mail: David_Nathan@dfci.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David G. Nathan, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01788631     History of Changes
Other Study ID Numbers: 13-005
1P50HL110790-01 ( U.S. NIH Grant/Contract )
First Submitted: February 7, 2013
First Posted: February 11, 2013
Results First Submitted: September 19, 2017
Results First Posted: February 7, 2018
Last Update Posted: February 7, 2018