Kidney Failure, ChronicPhase 2NCT00090194
Improving Transplant Options of Highly Sensitized Recipients Using IGIV-C, 10%
A Phase 2 study testing Immune Globulin Intravenous (Human), 10% in people with Kidney Failure, Chronic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in United States.
Trial summary
The purpose of this study is to determine if IGIV-C, 10% will be effective in converting a donor-recipient crossmatch status from positive to negative. The crossmatch test is used to determine if the donor tissue and recipient tissue are compatible. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Immune Globulin Intravenous (Human), 10%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 16 sitesUnited States
- Study dates
- Jun 2003to Mar 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- End-stage renal disease
- No known contraindications for therapy with IGIV-C, 10%
- Have identified a living kidney donor
- Positive crossmatch with the intended donor
- Parent or guardian willing to provide consent, if applicable
- Positive donor-specific crossmatch with the intended recipient
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- ECOG performance status 0 or 1
- Excellent health
- Acceptable laboratory parameters
- Compatible blood type
- Normal heart and lung evaluations
- Parent or guardian willing to provide consent, if applicable
Who cannot join
- Pregnant or breastfeeding
- Women of child-bearing age who are not willing or able to practice approved methods of contraception
- HIV infection
- Hepatitis B or hepatitis C infection
- History of positive tuberculin skin test
- Selective IgA deficiency, known anti-IgA antibodies, or history of severe allergy to any part of the clinical trial material
Show all 12Show fewer
- Have received or will receive multiple organ transplants
- Any licensed or investigational live attenuated vaccine within 2 months of the screening visit
- Patients deemed unable to comply with the protocol
- Heart attack within 1 year of screening
- History of clinically significant thrombotic episodes or active peripheral vascular disease
- Investigational agents within 4 weeks of study entry
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Michigan Hospitals
Ann Arbor, Michigan, 48109
Emory University Hospital
Atlanta, Georgia, 30322
Children's Hospital of Alabama
Birmingham, Alabama, 35233
University of Cincinnati
Cincinnati, Ohio, 45219
University of Texas Medical Branch
Galveston, Texas, 77555
Indiana University Medical Center
Indianapolis, Indiana, 46202
UCLA Medical Center
Los Angeles, California, 90095
University of Miami
Miami, Florida, 33136
Vanderbilt University Medical Center
Nashville, Tennessee, 37235
Banner Good Samaritan Regional Medical Center
Phoenix, Arizona, 85006
Rhode Island Hospital
Providence, Rhode Island, 02903
California Pacific Medical Center
San Francisco, California, 94115
University of San Francisco
San Francisco, California, 94117
Swedish Medical Center
Seattle, Washington, 98104
Washington Hospital Center
Washington D.C., District of Columbia, 20010
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Evaluation of Immune Globulin Intravenous (Human), 10%, Manufactured by Chromatography Process (IGIV-C, 10%), as an Agent to Reduce Anti-HLA Antibodies and Improve Transplantation Results in Cross Match Positive Living Donor Kidney Allograft Recipients
The purpose of this study is to determine if IGIV-C, 10% will be effective in converting a donor-recipient crossmatch status from positive to negative. The crossmatch test is used to determine if the donor tissue and recipient tissue are compatible. The study will also evaluate if IGIV-C, 10% will allow successful kidney transplantation in a patient who otherwise would not be able to receive a transplant. Three dose levels of IGIV-C, 10% will be evaluated to determine what dose level is most effective.
Read the detailed description
Kidney transplantation has emerged as the treatment of choice for patients with end-stage renal disease (ESRD). Preliminary data suggest that IGIV therapy could have significant benefits in modifying allograft rejection episodes, stabilizing long-term allograft function, and reducing ischemia/reperfusion injury.
Qualified patients will have an in-vitro assessment of the ability of IGIV-C, 10% to convert the donor-specific crossmatch (cytotoxic assay) from positive to negative. Those patients with successful in-vitro conversion of the donor-specific crossmatch assay will be randomized to receive IGIV-C, 10% intravenously at a dose of either 2 gm/kg, 1 gm/kg, or 0.5 gm/kg. IGIV-C, 10% will be administered 3 to 5 days prior to planned transplantation and, if transplantation is successful, 7 days post-transplant. If after receiving the IGIV-C infusion the donor-specific crossmatch reveals that cell death has fallen to 20% or less above background, the crossmatch will be considered negative. If after receiving one infusion the crossmatch remains positive, additional IGIV-C infusions may be administered at one-month intervals, up to 4 infusions. A repeat crossmatch must be obtained after each infusion. Patients will be followed for 12 months post-transplant. Concomitant therapy will include a standard immunosuppression regimen of mycophenolate mofetil, tacrolimus, and prednisone following induction therapy with thymoglobulin.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Immune Globulin Intravenous (Human), 10%
- Keywords
- Kidney Transplantation, Transplantation, Homologous, HLA Antigens, Autoantibodies, Immunoglobulins, Intravenous, Living Donors, Dose-Response Relationship, Immunologic
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Globulin Intravenous (Human), 10%Biological
| Study group | Role | What they receive |
|---|---|---|
| Low Dose | Experimental | 0.5 gm/kg at 5 days pre-transplant and 7 days post-transplant Receives: Biological: Immune Globulin Intravenous (Human), 10% |
| Middle Dose | Experimental | 1.0 gm/kg at 5 days pre-transplant and 7 days post-transplant Receives: Biological: Immune Globulin Intravenous (Human), 10% |
| High Dose | Experimental | 2.0 gm/kg at 5 days pre-transplant and 7 days post-transplant Receives: Biological: Immune Globulin Intravenous (Human), 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring of crossmatch conversion rate after one infusion of IGIV
Secondary outcomes (5)
Graft survival and function
average percentage panel reactive antibodies (PRA) reduction
donor-specific unresponsiveness and allo-responsiveness in ESRD patients
subject survival
safety endpoints, including incidence rates of infection, adverse events, and hospitalizations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2004 (estimated)
- Study startJun 2003
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stanley C. Jordan, MD, Study chair, Department of Pediatrics, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090194
- Sponsor's protocol ID
- DAIT IG03
- Status last verified
- Jan 2017
- First submitted
- 25 Aug 2004
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Publications
Akalin E, Ames S, Sehgal V, Fotino M, Daly L, Murphy B, Bromberg JS. Intravenous immunoglobulin and thymoglobulin facilitate kidney transplantation in complement-dependent cytotoxicity B-cell and flow cytometry T- or B-cell crossmatch-positive patients. Transplantation. 2003 Nov 27;76(10):1444-7. doi: 10.1097/01.TP.0000084200.40159.EC.
PubMed 14657683Jordan S, Cunningham-Rundles C, McEwan R. Utility of intravenous immune globulin in kidney transplantation: efficacy, safety, and cost implications. Am J Transplant. 2003 Jun;3(6):653-64. doi: 10.1034/j.1600-6143.2003.00121.x.
PubMed 12780556Jordan SC, Vo A, Bunnapradist S, Toyoda M, Peng A, Puliyanda D, Kamil E, Tyan D. Intravenous immune globulin treatment inhibits crossmatch positivity and allows for successful transplantation of incompatible organs in living-donor and cadaver recipients. Transplantation. 2003 Aug 27;76(4):631-6. doi: 10.1097/01.TP.0000080685.31697.FC.
PubMed 12973100Jordan SC, Vo AA, Toyoda M, Tyan D, Nast CC. Post-transplant therapy with high-dose intravenous gammaglobulin: Applications to treatment of antibody-mediated rejection. Pediatr Transplant. 2005 Apr;9(2):155-61. doi: 10.1111/j.1399-3046.2005.00256.x.
PubMed 15787786Zachary AA, Montgomery RA, Ratner LE, Samaniego-Picota M, Haas M, Kopchaliiska D, Leffell MS. Specific and durable elimination of antibody to donor HLA antigens in renal-transplant patients. Transplantation. 2003 Nov 27;76(10):1519-25. doi: 10.1097/01.TP.0000090868.88895.E0.
PubMed 14657698
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immune Globulin Intravenous (Human), 10%, Manufactured by Chromatography Process (IGIV-C, 10%), as an Agent to Reduce Anti-HLA Antibodies and Improve Transplantation Results in Cross Match Positive Living Donor Kidney Allograft Recipients
- ClinicalTrials.gov ID
- NCT00090194
- Acronym / sponsor ID
- DAIT IG03
- Conditions
- Kidney Failure, Chronic
- Keywords
- Kidney Transplantation, Transplantation, Homologous, HLA Antigens, Autoantibodies, Immunoglobulins, Intravenous, Living Donors, Dose-Response Relationship, Immunologic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 56 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2003
- Study completion
- Mar 2004 (actual)
- First posted
- 26 Aug 2004 (estimated)
- Results
- Not posted in the source record
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 IGIV-C, 10% will be effective in converting a donor-recipient crossmatch status from positive to negative. The crossmatch test is used to determine if the donor tissue and recipient tissue are compatible. The study will also evaluate if IGIV-C, 10% will allow successful kidney transplantation in a patient who otherwise would not be able to receive a transplant. Three dose levels of IGIV-C, 10% will be evaluated to determine what dose level is most effective.
Detailed description
Kidney transplantation has emerged as the treatment of choice for patients with end-stage renal disease (ESRD). Preliminary data suggest that IGIV therapy could have significant benefits in modifying allograft rejection episodes, stabilizing long-term allograft function, and reducing ischemia/reperfusion injury.
Qualified patients will have an in-vitro assessment of the ability of IGIV-C, 10% to convert the donor-specific crossmatch (cytotoxic assay) from positive to negative. Those patients with successful in-vitro conversion of the donor-specific crossmatch assay will be randomized to receive IGIV-C, 10% intravenously at a dose of either 2 gm/kg, 1 gm/kg, or 0.5 gm/kg. IGIV-C, 10% will be administered 3 to 5 days prior to planned transplantation and, if transplantation is successful, 7 days post-transplant. If after receiving the IGIV-C infusion the donor-specific crossmatch reveals that cell death has fallen to 20% or less above background, the crossmatch will be considered negative. If after receiving one infusion the crossmatch remains positive, additional IGIV-C infusions may be administered at one-month intervals, up to 4 infusions. A repeat crossmatch must be obtained after each infusion. Patients will be followed for 12 months post-transplant. Concomitant therapy will include a standard immunosuppression regimen of mycophenolate mofetil, tacrolimus, and prednisone following induction therapy with thymoglobulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose | Experimental | Biological: Immune Globulin Intravenous (Human), 10%0.5 gm/kg at 5 days pre-transplant and 7 days post-transplant |
| Middle Dose | Experimental | Biological: Immune Globulin Intravenous (Human), 10%1.0 gm/kg at 5 days pre-transplant and 7 days post-transplant |
| High Dose | Experimental | Biological: Immune Globulin Intravenous (Human), 10%2.0 gm/kg at 5 days pre-transplant and 7 days post-transplant |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- End-stage renal disease
- No known contraindications for therapy with IGIV-C, 10%
- Have identified a living kidney donor
- Positive crossmatch with the intended donor
- Parent or guardian willing to provide consent, if applicable
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding
- Women of child-bearing age who are not willing or able to practice approved methods of contraception
- HIV infection
- Hepatitis B or hepatitis C infection
- History of positive tuberculin skin test
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 |
|---|---|---|
| Immune Globulin Intravenous (Human), 10% | Biological | High Dose, Low Dose, Middle Dose |
Primary outcome
Monitoring of crossmatch conversion rate after one infusion of IGIV
5 secondary outcomes
Graft survival and function
average percentage panel reactive antibodies (PRA) reduction
donor-specific unresponsiveness and allo-responsiveness in ESRD patients
subject survival
safety endpoints, including incidence rates of infection, adverse events, and hospitalizations
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Background: PubMed 14657683Akalin E, Ames S, Sehgal V, Fotino M, Daly L, Murphy B, Bromberg JS. Intravenous immunoglobulin and thymoglobulin facilitate kidney transplantation in complement-dependent cytotoxicity B-cell and flow cytometry T- or B-cell crossmatch-positive patients. Transplantation. 2003 Nov 27;76(10):1444-7. doi: 10.1097/01.TP.0000084200.40159.EC.
- Background: PubMed 12780556Jordan S, Cunningham-Rundles C, McEwan R. Utility of intravenous immune globulin in kidney transplantation: efficacy, safety, and cost implications. Am J Transplant. 2003 Jun;3(6):653-64. doi: 10.1034/j.1600-6143.2003.00121.x.
- Background: PubMed 12973100Jordan SC, Vo A, Bunnapradist S, Toyoda M, Peng A, Puliyanda D, Kamil E, Tyan D. Intravenous immune globulin treatment inhibits crossmatch positivity and allows for successful transplantation of incompatible organs in living-donor and cadaver recipients. Transplantation. 2003 Aug 27;76(4):631-6. doi: 10.1097/01.TP.0000080685.31697.FC.
- Background: PubMed 15787786Jordan SC, Vo AA, Toyoda M, Tyan D, Nast CC. Post-transplant therapy with high-dose intravenous gammaglobulin: Applications to treatment of antibody-mediated rejection. Pediatr Transplant. 2005 Apr;9(2):155-61. doi: 10.1111/j.1399-3046.2005.00256.x.
- Background: PubMed 14657698Zachary AA, Montgomery RA, Ratner LE, Samaniego-Picota M, Haas M, Kopchaliiska D, Leffell MS. Specific and durable elimination of antibody to donor HLA antigens in renal-transplant patients. Transplantation. 2003 Nov 27;76(10):1519-25. doi: 10.1097/01.TP.0000090868.88895.E0.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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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.
Stanley C. Jordan, MD study chair
Department of Pediatrics, Cedars-Sinai Medical Center
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immune Globulin Intravenous (Human), 10% in people with Kidney Failure, Chronic, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites 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 12 inclusion and 12 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: stopped early, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
The study was stopped early. Results are not available in the source record.
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?
Monitoring of crossmatch conversion rate after one infusion of IGIV. 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 NCT00090194, which also lists 5 linked publications.
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 11 Jan 2017.