- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02659891
IVIg to Treat BK Viremia in Kidney Transplant Recipients
September 2, 2021 updated by: Hannah Gilligan, Massachusetts General Hospital
Immunoglobulin (Privigen®) Therapy to Treat BK Viremia and Prevent Alloimmune Activation in Kidney Transplant Recipients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, United States, 02114
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1 (Treatment)
Intravenous immune globulin (IVIg; Privigen®) 1g/kg monthly for 2 months with immunosuppression reduction.
|
Other Names:
|
Placebo Comparator: Group 2 (Control)
Placebo infusion monthly for 2 months with immunosuppression reduction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Donor specific anti-HLA antibodies
Time Frame: 12 Months
|
Prevention of new donor specific anti-HLA antibodies (DSA)
|
12 Months
|
Kidney graft survival
Time Frame: 12 Months
|
12 Months
|
|
Acute Cellular Rejection
Time Frame: 12 Months
|
Incidence of acute cellular rejection (Banff 2013 Criteria)
|
12 Months
|
BK Nephropathy
Time Frame: 12 Months
|
Proportion of BKV nephropathy
|
12 Months
|
Acute Antibody Mediated Rejection
Time Frame: 12 Months
|
Incidence of acute antibody mediated rejection
|
12 Months
|
Interstitial Fibrosis or Transplant Glomerulopathy
Time Frame: 12 Months
|
Incidence of interstitial fibrosis or transplant glomerulopathy
|
12 Months
|
Glomerular Filtrition Rate (GFR)
Time Frame: 12 Months
|
Proportion of delta decline in estimated glomerular filtration rate (MDRD) of >20%
|
12 Months
|
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
|
Up to 24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hannah Gilligan, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2016
Primary Completion (Actual)
December 10, 2020
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
January 14, 2016
First Submitted That Met QC Criteria
January 16, 2016
First Posted (Estimate)
January 21, 2016
Study Record Updates
Last Update Posted (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 2, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016P000224
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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