Kidney TransplantationPhase 1NCT02659891
IVIg to Treat BK Viremia in Kidney Transplant Recipients
A Phase 1 study testing IVIg in people with Kidney Transplantation and BK Virus, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation, BK Virus, Isoantibodies
- What is being tested?
- IVIg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to 31 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
- Conditions
- Kidney Transplantation, BK Virus, Isoantibodies
- Being tested
- IVIg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIgBiological
Also called Privigen®
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Treatment) | Active comparator | Intravenous immune globulin (IVIg; Privigen®) 1g/kg monthly for 2 months with immunosuppression reduction. Receives: Biological: IVIg |
| Group 2 (Control) | Placebo comparator | Placebo infusion monthly for 2 months with immunosuppression reduction Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BK Viremia
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.
Measured: 3 Months
Secondary outcomes (8)
Donor specific anti-HLA antibodies
Prevention of new donor specific anti-HLA antibodies (DSA)
Measured: 12 Months
Kidney graft survival
Measured: 12 Months
Acute Cellular Rejection
Incidence of acute cellular rejection (Banff 2013 Criteria)
Measured: 12 Months
BK Nephropathy
Proportion of BKV nephropathy
Measured: 12 Months
Acute Antibody Mediated Rejection
Incidence of acute antibody mediated rejection
Measured: 12 Months
Interstitial Fibrosis or Transplant Glomerulopathy
Incidence of interstitial fibrosis or transplant glomerulopathy
Measured: 12 Months
Glomerular Filtrition Rate (GFR)
Proportion of delta decline in estimated glomerular filtration rate (MDRD) of >20%
Measured: 12 Months
BKV remission
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
Measured: Up to 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startMay 2016
- Primary completion10 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Gilligan, Massachusetts General Hospital
- Investigators
- Hannah Gilligan, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659891
- Sponsor's protocol ID
- 2016P000224
- Status last verified
- Sep 2021
- First submitted
- 14 Jan 2016
- Last updated
- 5 Sep 2021
- Results posted
- No
Publications
He KD, Gressens SB, Dadhania DM, Gilligan HM, Davis C, Edusei E, Ahn J, Lifton M, Pastrana DV, Kleiboeker S, Buck CB, Jost S, Wojciechowski D, Tan CS. Immune Responses to BK Virus in Renal Transplant Recipients Receiving Intravenous Immunoglobulin Treatment. J Infect Dis. 2026 Feb 18;233(2):e392-e403. doi: 10.1093/infdis/jiaf525.
PubMed 41071936
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoglobulin (Privigen®) Therapy to Treat BK Viremia and Prevent Alloimmune Activation in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT02659891
- Acronym / sponsor ID
- 2016P000224
- Conditions
- Kidney Transplantation, BK Virus, Isoantibodies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Treatment) | Active comparator | Biological: IVIgIntravenous immune globulin (IVIg; Privigen®) 1g/kg monthly for 2 months with immunosuppression reduction. |
| Group 2 (Control) | Placebo comparator | Other: PlaceboPlacebo infusion monthly for 2 months with immunosuppression reduction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIgAlso: Privigen® | Biological | Group 1 (Treatment) |
| Placebo | Other | Group 2 (Control) |
Primary outcome
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.
8 secondary outcomes
Donor specific anti-HLA antibodies
Time frame: 12 Months
Kidney graft survival
Time frame: 12 Months
Acute Cellular Rejection
Time frame: 12 Months
BK Nephropathy
Time frame: 12 Months
Acute Antibody Mediated Rejection
Time frame: 12 Months
Interstitial Fibrosis or Transplant Glomerulopathy
Time frame: 12 Months
Glomerular Filtrition Rate (GFR)
Time frame: 12 Months
BKV remission
Time frame: Up to 24 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Derived from this study: PubMed 41071936He KD, Gressens SB, Dadhania DM, Gilligan HM, Davis C, Edusei E, Ahn J, Lifton M, Pastrana DV, Kleiboeker S, Buck CB, Jost S, Wojciechowski D, Tan CS. Immune Responses to BK Virus in Renal Transplant Recipients Receiving Intravenous Immunoglobulin Treatment. J Infect Dis. 2026 Feb 18;233(2):e392-e403. doi: 10.1093/infdis/jiaf525.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Gilligan, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IVIg in people with Kidney Transplantation and BK Virus, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BK Viremia (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02659891, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.