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

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