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A Prospective, Global, Multi-center, Treatment Registry Study of Intravenous Immunoglobulin Maintenance Therapy in Alloantibody Positive Renal Allograft Recipients

Information source: Databean
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Transplant Recipients With Anti-HLA Antibody (DSA) Positivity

Phase: N/A

Status: Recruiting

Sponsored by: Databean

Official(s) and/or principal investigator(s):
A. O. Gaber, MD, Principal Investigator, Affiliation: The Methodist Hospital System

Overall contact:
Jane Wilson, Phone: 845-721-8210, Email: janew@databean.com

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. 162 renal transplant subjects will receive IVIg 5% at 2gm/kg/month for 6 months and be followed for 3 years.

Clinical Details

Official title: A Prospective, Global, Multi-center, Treatment Registry Study of Intravenous Immunoglobulin Maintenance Therapy in Alloantibody Positive Renal Allograft Recipients

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Difference in mean change from screening to 36 months in graft survival and glomerular filtration rates (GFR)

Secondary outcome: Allograft Survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 above 1999 but equal to, or below, 15,000 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 Exclusion Criteria:

- 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

- Biopsy-proven acute rejection within 6 months prior to consent defined as Acute

Cellular Rejection [Banff grade I (including IA and IB), grade II (including IIA and IIB) or grade III], 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)

- Biopsy proven transplant glomerulopathy (TG) (Banff 2007 - cg score ≥2) within 6

months prior to consent

- Evidence of proteinuria (> 3 grams) within the 6 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 30 days prior to consent

- Subjects receiving cyclosporine as an immunosuppressive agent and who is unwilling,

or unable, to change to tacrolimus (Prograf) within 30 days prior to consent

- Absolute neutrophil 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: 1. Electrocardiographic evidence of MI, 2. Electrocardiographic evidence of acute ischemia, 3. Electrocardiographic evidence of severe conduction system abnormalities OR

4. 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

Locations and Contacts

Jane Wilson, Phone: 845-721-8210, Email: janew@databean.com

St Vincent's Transplant Research Institute, Los Angeles, California 90057, United States; Recruiting
Don Vu, Pharm.D, Phone: 213-384-4874, Email: donv@transplantri.com
Tariq Shah, MD, Principal Investigator

UCLA, Los Angeles, California 90024, United States; Not yet recruiting
Linda Malik, Phone: 310-794-8516, Email: LMalik@mednet.ucla.edu
Suphamai Bunnapradist, MD, Principal Investigator

University of California Davis Health Systems, Sacramento, California 95817, United States; Recruiting
Shari Nichols, Phone: 916-734-8943, Email: shari.nichols@ucdmc.ucdavis.edu
Bryan Gallay, MD, Principal Investigator
DeMattos Angelo, MD, Sub-Investigator

University of California, San Francisco, San Francisco, California 94143, United States; Recruiting
Deborah Adey, MD, Principal Investigator

University of Colorado, Denver, Aurora, Colorado 80045, United States; Recruiting
Janis Cicerchi, Phone: 303-724-0183, Email: janis.cicerchi@ucdenver.edu
James E Cooper, MD, Principal Investigator

University of Miami, Miami, Florida 33136, United States; Recruiting
Sandra Flores, Phone: 305-355-5315, Email: SFlores@med.miami.edu
Adela Mattiazzi, MD, Principal Investigator

Florida Hospital, Orlando, Florida 32804, United States; Recruiting
Stacy Shankleton, Phone: 407-303-2576, Email: stacy.shankleton@flhosp.org
Bobby Nibhanupudy, MD, Principal Investigator

Cornell Medical Center, New York, New York 10065, United States; Recruiting
Katrina Bandong, Phone: 212-746-6112, Email: kab2036@med.cornell.edu
Darshana Dadhania, MD, Principal Investigator

Baylor Research Institute, Fort Worth, Texas 76104, United States; Recruiting
Susan Pelletier, Phone: 817-922-2585, Email: Susan.pelletier@baylorhealth.edu
Yango Angelito, MD, Principal Investigator

Houston Methodist Hospital, Houston, Texas 77030, United States; Recruiting
Sarah Brann, Phone: 713-441-6394, Email: sjbrann@houstonmethodist.org
A O Gaber, MD, Principal Investigator

Additional Information

Starting date: July 2014
Last updated: July 30, 2015

Page last updated: August 23, 2015

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