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IVIg to Treat BK Viremia in Kidney Transplant Recipients

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ClinicalTrials.gov Identifier: NCT02659891
Recruitment Status : Recruiting
First Posted : January 21, 2016
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
David Wojciechowski, 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rhophylac

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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02659891


Contacts
Contact: David Wojciechowski, DO 617-724-9673 dwojciechowski@mgh.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sabrina Tan, MD       ctan@bidmc.harvard.edu   
Principal Investigator: Sabrina Tan, MD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Margaret Thomas    617-643-6266    mvthomas@mgh.harvard.edu   
Principal Investigator: David Wojciechowski, DO         
Sponsors and Collaborators
David Wojciechowski
Investigators
Principal Investigator: David Wojciechowski, DO Director, Clinical Transplant Nephrology Research

Responsible Party: David Wojciechowski, Director, Clinical Transplant Nephrology Research, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02659891     History of Changes
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Viremia
Virus Diseases
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs