Intravenous Immunoglobulin (IVIG) in Lung Transplantation
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| ClinicalTrials.gov Identifier: NCT00115778 |
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Recruitment Status :
Completed
First Posted : June 27, 2005
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypogammaglobulinemia Lung Transplantation | Drug: IVIG Other: Placebo | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 11 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | IVIG for Acquired Immunodeficiency in Lung Transplant Patients |
| Study Start Date : | June 2005 |
| Actual Primary Completion Date : | August 2009 |
| Actual Study Completion Date : | August 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: First IVIG, then Placebo
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.
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Drug: IVIG
10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks
Other Names:
Other: Placebo 0.1% Albumin in an equal volume to the investigational product |
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Experimental: First Placebo, then IVIG
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.
|
Drug: IVIG
10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks
Other Names:
Other: Placebo 0.1% Albumin in an equal volume to the investigational product |
- 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.
- Number of Clinically Diagnosed Viral Infections [ Time Frame: 3 month ]This is to measure the effect of IVIG on viral infections.
- Number of Hospital Admissions [ Time Frame: 3 month ]This is to measure the effect of IVIG on hospitalizations.
- Number of Antibiotic Initiation [ Time Frame: 3 month ]This is to measure the effect of IVIG on the use of antibiotics.
- Number of Clinically Diagnosed Fungal Infection [ Time Frame: 3 months ]This is to measure the effect of IVIG on fungal infections.
- Number of Lymphocytic Bronchiolitis [ Time Frame: 3 months ]This is to measure the effect of IVIG on lung function.
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| Ages Eligible for Study: | 12 Years to 75 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Lung transplant recipients > 3 months after transplant surgery
- Immunoglobulin G (IgG) < 500 mg/dL
- Stable medical regimen
Exclusion Criteria:
- Acute rejection
- Active infection
- Contraindication to IVIG
- Pregnancy
- Recent thrombotic event
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115778
| United States, New York | |
| New York Presbyterian Hospital Lung Transplant Program | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Selim M Arcasoy, M.D. | Columbia University |
| Responsible Party: | Selim Arcasoy, Dickinson W. Richards, Jr. Professor of Medicine (in Pediatrics) at the Columbia University Medical Center, Dept of Medicine Pulmonary, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00115778 |
| Other Study ID Numbers: |
AAAB0431 |
| First Posted: | June 27, 2005 Key Record Dates |
| Results First Posted: | March 5, 2019 |
| Last Update Posted: | March 5, 2019 |
| Last Verified: | February 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Hypogammaglobulinemia Lung Transplantation |
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Agammaglobulinemia Blood Protein Disorders Hematologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Immunoglobulins Immunoglobulins, Intravenous gamma-Globulins Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |