HypogammaglobulinemiaPhase 2NCT00115778
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
A Phase 2 study testing IVIG in people with Hypogammaglobulinemia and Lung Transplantation, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Hypogammaglobulinemia, Lung Transplantation
- What is being tested?
- IVIG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lung transplant recipients > 3 months after transplant surgery
- Immunoglobulin G (IgG) < 500 mg/dL
- Stable medical regimen
Who cannot join
- Acute rejection
- Active infection
- Contraindication to IVIG
- Pregnancy
- Recent thrombotic event
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital Lung Transplant Program
New York, New York, 10032
About this study
Official title: IVIG for Acquired Immunodeficiency in Lung Transplant Patients
The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
Read the detailed description
An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation. Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant recipients with HGG, IVIG therapy offers the potential to significantly decrease the incidence and severity of infections, thereby reducing morbidity and potentially mortality.
Comparison: The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients.
- Conditions
- Hypogammaglobulinemia, Lung Transplantation
- Being tested
- IVIG, Placebo
- Keywords
- Hypogammaglobulinemia, Lung Transplantation
- Medical subject headings
- Agammaglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIGDrug
Also called Immune globulin intravenous, Gamunex, Intravenous immunoglobulin
10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks
PlaceboOther
0.1% Albumin in an equal volume to the investigational product
| Study group | Role | What they receive |
|---|---|---|
| First IVIG, then Placebo | Experimental | Study participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks. Receives: Drug: IVIG; Other: Placebo |
| First Placebo, then IVIG | Experimental | Study participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of IVIG over 12 weeks. Receives: Drug: IVIG; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Clinically Diagnosed Bacterial Infections During the Treatment Period
The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.
Measured: 3 month
Secondary outcomes (5)
Number of Clinically Diagnosed Viral Infections
This is to measure the effect of IVIG on viral infections.
Measured: 3 month
Number of Hospital Admissions
This is to measure the effect of IVIG on hospitalizations.
Measured: 3 month
Number of Antibiotic Initiation
This is to measure the effect of IVIG on the use of antibiotics.
Measured: 3 month
Number of Clinically Diagnosed Fungal Infection
This is to measure the effect of IVIG on fungal infections.
Measured: 3 months
Number of Lymphocytic Bronchiolitis
This is to measure the effect of IVIG on lung function.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2005 (estimated)
- Study startJun 2005
- Primary completionAug 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypogammaglobulinemiaStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Grifols Therapeutics LLC
- Responsible party
- Principal investigator, Selim Arcasoy, Columbia University
- Investigators
- Selim M Arcasoy, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115778
- Sponsor's protocol ID
- AAAB0431
- Status last verified
- Feb 2019
- First submitted
- 26 Jun 2005
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lederer DJ, Philip N, Rybak D, Arcasoy SM, Kawut SM. Intravenous immunoglobulin for hypogammaglobulinemia after lung transplantation: a randomized crossover trial. PLoS One. 2014 Aug 4;9(8):e103908. doi: 10.1371/journal.pone.0103908. eCollection 2014.
PubMed 25090414
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVIG for Acquired Immunodeficiency in Lung Transplant Patients
- ClinicalTrials.gov ID
- NCT00115778
- Acronym / sponsor ID
- AAAB0431
- Conditions
- Hypogammaglobulinemia, Lung Transplantation
- Keywords
- Hypogammaglobulinemia, Lung Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Grifols Therapeutics LLC
- Study start
- Jun 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Jun 2005 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
Detailed description
An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation. Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant recipients with HGG, IVIG therapy offers the potential to significantly decrease the incidence and severity of infections, thereby reducing morbidity and potentially mortality.
Comparison: The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First IVIG, then Placebo | Experimental | Drug: IVIG, Other: PlaceboStudy participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks. |
| First Placebo, then IVIG | Experimental | Drug: IVIG, Other: PlaceboStudy participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of IVIG over 12 weeks. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Lung transplant recipients > 3 months after transplant surgery
- Immunoglobulin G (IgG) < 500 mg/dL
- Stable medical regimen
Key exclusion criteria (5 listed)
- Acute rejection
- Active infection
- Contraindication to IVIG
- Pregnancy
- Recent thrombotic event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIGAlso: Immune globulin intravenous, Gamunex, Intravenous immunoglobulin10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks | Drug | First IVIG, then Placebo, First Placebo, then IVIG |
| Placebo0.1% Albumin in an equal volume to the investigational product | Other | First IVIG, then Placebo, First Placebo, then IVIG |
Primary outcome
Number of Clinically Diagnosed Bacterial Infections During the Treatment Period
Time frame: 3 month
The number of events occurring during the treatment period. The data will be presented by the occurrence during the IVIG vs. the placebo treatment period, regardless of the order that the treatment was received. Only the clinically diagnosed bacterial infections will be counted.
5 secondary outcomes
Number of Clinically Diagnosed Viral Infections
Time frame: 3 month
Number of Hospital Admissions
Time frame: 3 month
Number of Antibiotic Initiation
Time frame: 3 month
Number of Clinically Diagnosed Fungal Infection
Time frame: 3 months
Number of Lymphocytic Bronchiolitis
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25090414Lederer DJ, Philip N, Rybak D, Arcasoy SM, Kawut SM. Intravenous immunoglobulin for hypogammaglobulinemia after lung transplantation: a randomized crossover trial. PLoS One. 2014 Aug 4;9(8):e103908. doi: 10.1371/journal.pone.0103908. eCollection 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim M Arcasoy, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IVIG in people with Hypogammaglobulinemia and Lung Transplantation, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Clinically Diagnosed Bacterial Infections During the Treatment Period (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00115778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.