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IVIg to Treat BK Viremia in Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02659891
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : September 5, 2021
Information provided by (Responsible Party):
Hannah Gilligan, Massachusetts General Hospital

Brief Summary:
The overall goal of this study is to rapidly improve clearance of BK viremia with Immunoglobulin (Privigen®) thereby decreasing the potential for formation of alloantibodies in renal transplant recipients that have had immunosuppression reduction due to BK viremia. Our approach is to perform a prospective, randomized, placebo controlled trial intravenous immune globulin (IVIg; Privigen®) plus protocolized immunosuppression reduction versus placebo and protocolized immunosuppression reduction in patients with BK viremia post-kidney transplantation.

Condition or disease Intervention/treatment Phase
Kidney Transplantation BK Virus Isoantibodies Biological: IVIg Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Immunoglobulin (Privigen®) Therapy to Treat BK Viremia and Prevent Alloimmune Activation in Kidney Transplant Recipients
Study Start Date : May 2016
Actual Primary Completion Date : December 10, 2020
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Group 1 (Treatment)
Intravenous immune globulin (IVIg; Privigen®) 1g/kg monthly for 2 months with immunosuppression reduction.
Biological: IVIg
Other Name: Privigen®

Placebo Comparator: Group 2 (Control)
Placebo infusion monthly for 2 months with immunosuppression reduction
Other: Placebo

Primary Outcome Measures :
  1. BK Viremia [ Time Frame: 3 Months ]
    Resolution of BK viremia by 3 months post-enrollment. Resolution is defined as a decrease in viral load of BKV in the plasma to <1000 copies/mL.

Secondary Outcome Measures :
  1. Donor specific anti-HLA antibodies [ Time Frame: 12 Months ]
    Prevention of new donor specific anti-HLA antibodies (DSA)

  2. Kidney graft survival [ Time Frame: 12 Months ]
  3. Acute Cellular Rejection [ Time Frame: 12 Months ]
    Incidence of acute cellular rejection (Banff 2013 Criteria)

  4. BK Nephropathy [ Time Frame: 12 Months ]
    Proportion of BKV nephropathy

  5. Acute Antibody Mediated Rejection [ Time Frame: 12 Months ]
    Incidence of acute antibody mediated rejection

  6. Interstitial Fibrosis or Transplant Glomerulopathy [ Time Frame: 12 Months ]
    Incidence of interstitial fibrosis or transplant glomerulopathy

  7. Glomerular Filtrition Rate (GFR) [ Time Frame: 12 Months ]
    Proportion of delta decline in estimated glomerular filtration rate (MDRD) of >20%

  8. BKV remission [ Time Frame: Up to 24 Months ]
    Length of BKV remission (time from clearance of BK viremia to reappearance of BK viremia (plasma DNA load >1000 copies/mL x 2 measures that are a 4weeks apart) or end of study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of intravenous immune globulin, or agree to completely abstain from heterosexual intercourse.
  • Kidney transplant recipients (living and deceased donors) with new onset BK viremia (defined as BKV plasma DNA load >1000 copies/mL by real-time PCR within 2 weeks of enrollment). For values >5000 copies/mL repeat testing is not required. For values ≤5000 copies/mL repeat testing should be performed to confirm viremia before enrollment.
  • Immunosuppression therapy at enrollment with tacrolimus, MPA, +/- prednisone.
  • Men and Women 18 to 75 years of age.

Exclusion Criteria:

  • Absence of a DQ mismatch to the donor.
  • Patient had known HLA antibodies directed to the donor antigens (pre-formed DSA) prior to transplant.
  • Known to be positive for donor specific anti-HLA antibodies (IgG) at time of enrollment from the most recently drawn sample. (DSA MFI>1000 is considered positive). DSA is detected via center's standard of care testing. If center does not routinely screen then patient may still be enrolled.
  • History of biopsy proven acute rejection (cellular or antibody) at any time prior to enrollment.
  • BKV plasma DNA viral load >300,000 copies/ml.
  • Patient who have received intravenous immune globulin for any reason within 1 month prior to enrollment.
  • Patient with an estimated glomerular filtration rate (MDRD) ≤ 30 ml/min at time of study entry.
  • Patient with selective IgA deficiency or have known antibodies to IgA.
  • Patient with history of hyperprolinemia.
  • Patient with a previous history of a severe systemic or anaphylactic response to intravenous immune globulin.
  • Female subject is pregnant or lactating.
  • Current HCV positivity (by PCR).
  • History of HBsAg-positive.
  • Patients who are HIV-positive.
  • Recipients of a kidney from a donor who tests positive for HIV or HBsAg
  • Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
  • Inability to perform follow-up or to undergo renal allograft biopsy.
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02659891

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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Hannah Gilligan, MD Massachusetts General Hospital
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Responsible Party: Hannah Gilligan, Transplant Nephrologist, Massachusetts General Hospital Identifier: NCT02659891    
Other Study ID Numbers: 2016P000224
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Virus Diseases
Systemic Inflammatory Response Syndrome
Pathologic Processes
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs