A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)
A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)
2 other identifiers
interventional
119
1 country
23
Brief Summary
The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary function as measured by a 5% or greater relative improvement in forced expiratory volume in one second (FEV1) from baseline to Day 28. Funding Source - FDA OOPD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2016
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2014
CompletedFirst Posted
Study publicly available on registry
February 3, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedResults Posted
Study results publicly available
March 21, 2019
CompletedMarch 21, 2019
March 1, 2019
1.9 years
July 30, 2014
January 28, 2019
March 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28
Difference between treatment groups in the proportion of subjects with 5% or greater relative change in FEV1 (liters) from baseline to Day 28.
Baseline to Day 28
Secondary Outcomes (5)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 1 to Day 56
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Day 1 to Day 56
Relative Change in FEV1 (Liters) From Baseline to Day 56
Day 1 to Day 56
Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline to Day 56
Day 1 to Day 56
Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), From Baseline to Day 56
Day 1 to Day 56
Study Arms (2)
5 day of infusion of gallium nitrate
ACTIVE COMPARATORGallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days.
5 day of infusion of normal saline
PLACEBO COMPARATORPlacebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga
Interventions
Study subjects will receive an infusion of either placebo or gallium nitrate.
Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Eligibility Criteria
You may qualify if:
- Greater than or equal to 18 years of age at Screening
- Documented chronic colonization with P. aeruginosa defined as dentification in two sputum or oropharyngeal cultures within the year prior to Day 1
- Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
- two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
- Abnormal nasal potential difference (NPD; change in NPD in response to a low chloride solution and isoproteronol of less than -5 mV)
- FEV1 ≥ 25 % of predicted value at Screening
- Able to expectorate sputum
- Serum liver function tests ≤ 2.5 x upper limit of normal at Screening
- Serum urea nitrogen (BUN) ≤ 1.5 x upper limit of normal at Screening
- Serum creatinine ≤ 2.0 mg/dl and ≤ 1.5 x upper limit of normal at Screening
- Hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/mm3, and white blood cells (WBC)
- ≥ 4,500/mm3 at Screening
- Ionized calcium ≥ lower limit of normal at Screening
- Written informed consent obtained from subject or subject's legal representative
- +5 more criteria
You may not qualify if:
- Use of inhaled antibiotics within seven days prior to Day 1
- Unable or unwilling to withhold use of chronic inhaled antibiotics through Day 28
- Use of intravenous, inhaled, or oral antibiotics for an acute indication within 14 days prior to Day 1
- Use of bisphosphonates within seven days prior to Day 1
- History of osteoporosis (defined as the most recent dexa scan with a T-score ≤ -2.5 with the dexa scan performed within the five years prior to Screening)
- Lactating female
- Known sensitivity to gallium
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Cystic Fibrosis Foundationcollaborator
Study Sites (23)
AL Adult Birmingham / The Children's Hospital Atlanta
Birmingham, Alabama, 35233, United States
UC San Diego Medical Center
La Jolla, California, 92037, United States
Denver Adult / National Jewish Health
Denver, Colorado, 80206, United States
Shands Hospital
Gainesville, Florida, 32610, United States
Jackson Memorial Hospital; University of Miami Hospital; University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
Atlanta Emory Adult / Emory University Hospital
Atlanta, Georgia, 30322, United States
Chicago Northwestern Adult / Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Iowa City University of Iowa Adult / University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Lexington, KY Adult / University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40506-9983, United States
Portland, ME Adult
Portland, Maine, 04102, United States
Baltimore Hopkins Adult / John Hopkins Hospital
Baltimore, Maryland, 21205, United States
Boston CHB Adult / Boston Children's Hospital (BCH)
Boston, Massachusetts, 02115, United States
Minneapolis CC and Adult / University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455, United States
Omaha Adult / The Nebraska Medical Center
Omaha, Nebraska, 68198-5300, United States
Lebanon, NH Dartmouth-Hitchcock CC and Adult / Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cleveland CC and Peds, Hospital of Cleveland
Cleveland, Ohio, 44106, United States
Columbus CC and Peds / Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Toledo, OH CC and Peds / The Toledo Hospital; Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Oklahoma City Adult / Presbyterian Hospital at OU Medical Center
Oklahoma City, Oklahoma, 73104, United States
Pittsburgh Adult, Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, 15224, United States
SC CC and Adult Charleston / MUSC
Charleston, South Carolina, 29425, United States
Salt Lake City Adult, Intermountain Cystic Fibrosis Center
Salt Lake City, Utah, 84132, United States
Seattle UW Adult / University of Washington Medical Center
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher H. Goss, Professor of Medicine and Pediatrics
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher H Goss, MD
University of Washington
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Medicine/Pulmonary & Critical Care Medicine
Study Record Dates
First Submitted
July 30, 2014
First Posted
February 3, 2015
Study Start
March 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
March 21, 2019
Results First Posted
March 21, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will share
Once the study is complete and the primary paper is published, de-identified data will be available from the Cystic Fibrosis Therapeutics Development Network Coordinating Center upon approval of a formal data request.