Renal Transplant Recipients With Anti-HLA AntibodiesDSANCT02115503
A Prospective, Global, Multi-center, Treatment Registry Study of Intravenous Immunoglobulin Maintenance Therapy in Alloantibody Positive Renal Allograft Recipients
An observational study of Renal Transplant Recipients With Anti-HLA Antibodies, run by Databean at 8 sites in United States.
Trial summary
The purpose of this treatment registry study is to determine if monthly infusions of Intravenous Immunoglobulin (IVIg) for 6 months will neutralize donor specific antibodies that are thought to be responsible for chronic rejection episodes in renal transplant subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Recipients With Anti-HLA Antibodies
- How many people
- 52 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2014to Apr 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Subject is 18 years of age or older
- Able to provide voluntary written informed consent
- Renal transplant recipient at least 1 month post-transplant
- On stable doses of maintenance immunosuppression for at least 14 days prior to study entry and remains on stable maintenance doses for the duration of the study
- Presence of DSA greater than or equal to 1000 mean fluorescence intensity (MFI) single antigen bead assay via Luminex (normalized 2,000 - 15,000 MFI, inclusive) measured within 6 months prior to consent
- Female subjects must be post-menopausal for at least 1 year, or surgically sterilized, or must agree to use two effective methods of birth control from the time of consent through 30 days after the last dose of IVIg.
- Male subjects must be surgically sterilized, or must agree to use two effective methods of birth control from the time of consent through 30 days after the last dose of IVIg
- Subject is compliant and intends to be available for follow-up study period of 3 years
Who cannot join
- Multi-organ transplant
- History of anaphylactic or severe systemic reactions to human immunoglobulin
- IgA deficient subjects with antibodies against IgA and a history of hypersensitivity
- Serum creatinine > 3.0 mg/dL within 90 days prior to consent
- Recipients of ABO incompatible kidney transplants
- Acute rejection within 180 days (6 months) prior to consent defined as:
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- Biopsy proven acute Cellular Rejection [Banff grade I (including IA and IB), grade II (including IIA and IIB) or grade III]; or
- an antibody-mediated rejection with C4d positivity, or
- chronic rejection with C4d positivity (C4d positivity is defined as staining diffuse in peritubular capillary area. Isolated C4d glomerular staining or C4d staining of < 50% of the peritubular capillaries will not be exclusion criteria). Borderline cellular rejection will not be excluded (Banff 2005), or
- Clinical signs and symptoms of acute rejection including elevated creatinine, fever over 100 degrees, pain or tenderness around the transplanted kidney, fluid retention of the hands, legs, feet, ankles or eyelids, sudden weight gain (2-4 pounds in a day, or 5 pounds or more in a week), decrease in urine output with the same amount of fluid intake, or dark yellow or orange urine output, flu-like symptoms, such as chills, aches, tiredness, dizziness, nausea, loss of appetite, weakness, fatigue, vomiting or general sense of not feeling well (Note: NOT all signs and symptoms need to be present to document acute rejection)
- Evidence of proteinuria (> 3 grams) within 90 days (3 months) prior to consent
- Active CMV+ or EBV+ viremia that requires, or will require, anti-viral therapy
- History of HCV, HIV and/or HBsAg positivity
- History of post-transplant lymphoproliferative disease.
- Active BK/polyomavirus nephropathy, or BK/polyomavirus nephritis that requires, or will require, anti-viral therapy (not prophylactic)
- Recipients of a kidney from a donor who tests positive for HIV, HBsAg or anti-HCV.
- History of malignancy within the past 5 years that is not considered to be cured, with the exception of complete resection of localized basal cell carcinoma of the skin (excised ≥ 1 years prior to enrollment).
- Subjects who are receiving everolimus, sirolimus or azathioprine as immunosuppressive agents and who are unwilling, or unable, to change to mycophenolate mofetil or mycophenolic acid within 14 days prior to consent
- White blood cell count of <1,000/mm3 within 90 days prior to consent
- Platelet count <60,000/mm3 within 90 days prior to consent
- Evidence of severe liver disease with abnormal liver profile (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3 times upper limit of normal [ULN]) within 90 days prior to consent
- Total bilirubin > 1.5 times ULN within 90 days prior to consent
- Post-transplant history of cardiovascular disease within 180 days (6 months) prior to consent defined as:
- Electrocardiographic evidence of MI,
- Electrocardiographic evidence of acute ischemia,
- Electrocardiographic evidence of severe conduction system abnormalities OR
- New York Heart Association (NYHA) Class II - IV heart failure (Subjects with other cardiac abnormalities may be included if documented by the investigator as not clinically significant)
- Pregnant or nursing (lactating) women
- Enrolled in any other treatment study within 30 days of consent
- Serious medical illness (other than renal disease), or psychiatric illness likely to interfere with study participation
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Colorado, Denver
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Baylor Research Institute
Fort Worth, Texas, 76104
Houston Methodist Hospital
Houston, Texas, 77030
St Vincent's Transplant Research Institute
Los Angeles, California, 90057
University of Miami
Miami, Florida, 33136
Cornell Medical Center
New York, New York, 10021
University of California Davis Health Systems
Sacramento, California, 95817
About this study
The purpose of this treatment registry study is to determine if monthly infusions of Intravenous Immunoglobulin (IVIg) for 6 months will neutralize donor specific antibodies that are thought to be responsible for chronic rejection episodes in renal transplant subjects. 162 renal transplant subjects will receive IVIg 5% at 2gm/kg/month for 6 months and be followed for 3 years.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Cohort 1 will consist of those having primarily Class I antibody development post-transplant | |
| Cohort 2 | Cohort 2 will include those having primarily Class II antibody development post-transplant | |
| Cohort 3 | Cohort 3 will consist of the remaining subjects that have a mix of Class I and II antibodies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean change from screening to 36 months in graft survival and glomerular filtration rates (GFR)
Success is defined as:
Allograft survival as compared to the performance goal (PG) at 36 months. For the purposes of this study, a graft will be presumed to be lost is when a subject is started on dialysis and is not able to subsequently be removed from dialysis; or a subject's serum creatinine reaches 4.0 mg/dL, is sustained for >48hours and is not thought to be due to other causes; or the subject is re-transplanted; or the subject dies. AND:
A change in extended GFR, defined as <15% decrease in mean GFR from baseline to 36 months
Measured: 3 years
Secondary outcomes (1)
Allograft Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2019
- Study completionApr 2020
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant Recipients With Anti-HLA AntibodiesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Databean
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Octapharma
- Responsible party
- Sponsor
- Investigators
- A. O. Gaber, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115503
- Sponsor's protocol ID
- DSA 3242014
- Acronym
- DSA
- Status last verified
- Feb 2024
- First submitted
- 4 Apr 2014
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Global, Multi-center, Treatment Registry Study of Intravenous Immunoglobulin Maintenance Therapy in Alloantibody Positive Renal Allograft Recipients
- ClinicalTrials.gov ID
- NCT02115503
- Acronym / sponsor ID
- DSA / DSA 3242014
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 52 participants (actual)
- Lead sponsor
- DatabeanIndustry (pharma, biotech, devices)
- Collaborators
- Octapharma
- Study start
- Jul 2014
- Primary completion
- Aug 2019 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 16 Apr 2014 (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 treatment registry study is to determine if monthly infusions of Intravenous Immunoglobulin (IVIg) for 6 months will neutralize donor specific antibodies that are thought to be responsible for chronic rejection episodes in renal transplant subjects. 162 renal transplant subjects will receive IVIg 5% at 2gm/kg/month for 6 months and be followed for 3 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Cohort 1 will consist of those having primarily Class I antibody development post-transplant |
| Cohort 2 | – | –Cohort 2 will include those having primarily Class II antibody development post-transplant |
| Cohort 3 | – | –Cohort 3 will consist of the remaining subjects that have a mix of Class I and II antibodies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (8 listed)
- Subject is 18 years of age or older
- Able to provide voluntary written informed consent
- Renal transplant recipient at least 1 month post-transplant
- On stable doses of maintenance immunosuppression for at least 14 days prior to study entry and remains on stable maintenance doses for the duration of the study
- Presence of DSA greater than or equal to 1000 mean fluorescence intensity (MFI) single antigen bead assay via Luminex (normalized 2,000 - 15,000 MFI, inclusive) measured within 6 months prior to consent
Key exclusion criteria (30 listed)
- Multi-organ transplant
- History of anaphylactic or severe systemic reactions to human immunoglobulin
- IgA deficient subjects with antibodies against IgA and a history of hypersensitivity
- Serum creatinine > 3.0 mg/dL within 90 days prior to consent
- Recipients of ABO incompatible kidney transplants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in mean change from screening to 36 months in graft survival and glomerular filtration rates (GFR)
Time frame: 3 years
Success is defined as: Allograft survival as compared to the performance goal (PG) at 36 months. For the purposes of this study, a graft will be presumed to be lost is when a subject is started on dialysis and is not able to subsequently be removed from dialysis; or a subject's serum creatinine reaches 4.0 mg/dL, is sustained for >48hours and is not thought to be due to other causes; or the subject is re-transplanted; or the subject dies. AND: A change in extended GFR, defined as <15% decrease in mean GFR from baseline to 36 months
1 secondary outcome
Allograft Survival
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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.
A. O. Gaber, MD principal investigator
The Methodist Hospital Research Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant Recipients With Anti-HLA Antibodies, run by Databean at 8 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 8 inclusion and 30 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment). 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?
Difference in mean change from screening to 36 months in graft survival and glomerular filtration rates (GFR) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.