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Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients (SAFE KIDNEY II)

Primary Purpose

BK Viremia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anti-BK polyomavirus (AntiBKV)
Sponsored by
Memo Therapeutics AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BK Viremia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female aged 18 years or older Kidney transplantation within 24 months prior to enrollment Kidney transplant recipient with first-time BK viremia (evaluated during routine clinical monitoring by the local laboratory and acknowledged by a physician within 35 days prior to day 1). BK viremia either defined by BK virus (BKV)-DNAemia of >1,000 copies/mL sustained for three weeks (confirmed by 2 consecutive measurements 3 weeks apart), or one time >10,000 copies/mL) Kidney transplant recipients with adequate and/or stable allograft function as indicated by estimated glomerular filtration rate ((e)GFR) ≥ 30 mL/min Female subjects (if of childbearing potential) must agree to use adequate and reliable contraceptive measures throughout their participation in the trial. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Ability to provide written informed consent Exclusion Criteria: Patients with previous diagnosis of BK viremia (defined as >1,000 copies/mL sustained for three weeks (confirmed by 2 consecutive measurements 3 weeks apart), or one time >10,000 copies/mL since last kidney transplant Known hypersensitivity to any component of the investigational medicinal product (IMP) Participants with combined or multi-organ transplants Transplanted kidney disease with an estimated glomerular filtration rate ((e)GFR) < 30 mL/minute at screening Uncontrolled acute or chronic infection other than BK virus (BKV) infection at screening which might interfere with study participation at the discretion of the investigator Recipients who are treated or planned to be treated with a mammalian Target of Rapamycin (mTOR) inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the study period. Recipients who are treated or planned to be treated during study participation with leflunomide at the time of enrollment and during the study period. Recipients who in the opinion of the investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depleting therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg) Recipients with kidney transplant rejection or focal segmental glomerulosclerosis (FSGS) shown by renal biopsy Recipients who have medical conditions that prevent the recipient from undergoing allograft biopsy due to chronic anticoagulation or antiplatelet agents (except for low dose aspirin) Recipients with known donor-specific antibodies (DSA) (de novo or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (<1000 mean fluorescence intensity (MFI) can be includred if no impact on the study assessments is expected by the discretion of the investigator Recipients who are receiving a monoclonal antibody treatment for another indication (e.g. rituximab, infliximab etc.) Recipients with extremely high BK virus (BKV)-DNAemia (>10,000,000 copies/mL) or hemorrhagic cystitis Recipients who in the opinion of the investigator are likely to develop recurrent native kidney disease (e.g. immunoglobulin A [IgA] nephritis, focal segmental glomerulosclerosis [FSGS], C3 glomerulonephritis) Recipients with a functionally significant ureteral stricture Pregnant or nursing (lactating) women Current clinical, radiographic, or laboratory evidence of active or latent tuberculosis (TB) or any history, in the opinion of the investigator, that confers a risk of reactivation of latent tuberculosis (TB) and precludes the use of conventional immunosuppression History of splenectomy or asplenia Any condition, that in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of the participant safety data or study results History of malignancy within the past 5 years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least 2 years prior to screening Participation in another interventional clinical trial during trial participation or within 30 days prior to the investigational medicinal product (IMP) dosing or planned dosing History of alcoholism or drug addiction within 1 year of screening. Substance use disorder will be an exclusion criterion, at investigators discretion

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Mayo ClinicRecruiting
  • University of California, Los AngelesRecruiting
  • Cedars-Sinai Medical CenterRecruiting
  • University of California DavisRecruiting
  • Hartford HospitalRecruiting
  • Yale University School of MedicineRecruiting
  • MedStar Georgetown University HospitalRecruiting
  • Mayo Clinic Transplant CenterRecruiting
  • University of Kansas Medical CenterRecruiting
  • University of MarylandRecruiting
  • Massachusetts General HospitalRecruiting
  • Harvard Medical School
  • University of Michigan Health SystemRecruiting
  • Washington University School of Medicine in St. LouisRecruiting
  • Saint Barnabas Medical CenterRecruiting
  • New York Presbyterian Hospital - Weill Cornell Medical CenterRecruiting
  • Metrolina Nephrology Associates (MNA), PARecruiting
  • Cleveland ClinicRecruiting
  • Ohio State UniversityRecruiting
  • University of Pennsylvania Hospital of PennsylvaniaRecruiting
  • UT SouthwesternRecruiting
  • University of Washington Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anti-BK polyomavirus (AntiBKV)

Placebo

Arm Description

1,000mg Anti-BK polyomavirus (AntiBKV) intravenous infusion every 4 weeks (4 doses)

Placebo intravenous infusion every 4 weeks (4 doses)

Outcomes

Primary Outcome Measures

Proportion of participants without detectable BK virus in the blood at Day 141
To evaluate the therapeutic efficacy of AntiBKV in decreasing BK virus plasma concentration below the detection limit at Day 141 in Kidney Transplant Recipients (KTRs) with BK viremia and to assess the sample size for the phase III part of the study.
To assess whether treatment with AntiBKV decreases BK virus plasma concentration below the detection limit at day 141 in Kidney Transplant Recipients (KRTs) with BK viremia.
Proportion of participants without detectable BK virus in the blood at day 141

Secondary Outcome Measures

To assess whether treatment with AntiBKV decreases viral DNA load at Day 8 in Kidney Transplant Recipients (KTRs) with BK viremia in a clinically relevant manner.
The proportion of participants with at least -1 log10 copies/mL change from baseline in BK viral DNA load at Day 8 of the placebo and AntiBKV group will be compared using the superiority by a margin test for two proportions.
Incidence, severity, and causal relationship of treatment-emergent adverse events (TEAEs) according to treatment group throughout the study
Blood samples for safety laboratory assessments (Standard measures for hematology and chemistry) will be taken at all visits. Monitoring for injection site reactions and infusion-related reactions will be conducted as part of routine safety assessments for this study, including signs and symptoms of anaphylaxis - performed at every visit, during infusion and for at least 1 hour after infusion. Vital signs will be taken at every visit and monitored every 30 minutes after start of infusion until at least 1 hour after end of infusion.
Assess whether treatment with AntiBKV results in a clinically relevant decrease in viral DNA load in Kidney Transplant Recipients (KTRs) with BK viremia throughout the study
Percentage and cumulative number of participants with at least -1 log10 copies/mL change from baseline in BK viral DNA load up to day 267.
Assess renal function for Kidney Transplant Recipients (KTRs) with BK viremia throughout the study
Change from baseline in renal function as measured by serum creatinine (SCr) and estimated glomerular filtration rate (e)GFR (by CKD-EPI formula) until end of follow-up.
Kidney graft lost and biopsy-confirmed BKVAN
Kidney graft lost and biopsy-confirmed BKVAN will be studied by Kaplan-Meier analyses for time to event data. Percentage and cumulative number of participants with progression to BKVAN confirmed by kidney biopsies (using the Banff criteria) prior to first dose, day 141 and an optional biopsy at day 267. Percentage and cumulative incidence of participants developing clinically apparent nephropathy until end of follow-up

Full Information

First Posted
March 3, 2023
Last Updated
September 22, 2023
Sponsor
Memo Therapeutics AG
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1. Study Identification

Unique Protocol Identification Number
NCT05769582
Brief Title
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients
Acronym
SAFE KIDNEY II
Official Title
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients, a Randomized Phase II/III Study, Double-blind and Placebo-controlled
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
November 24, 2024 (Anticipated)
Study Completion Date
November 24, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memo Therapeutics AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BK viremia and progression to biopsy-confirmed BKVAN in Kidney Transplant Recipients (KTRs). The study includes two parts. The phase II part will evaluate the safety of AntiBKV in KTRs and establish proof of concept. The phase III part will assess the efficacy of AntiBKV in KTRs. For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of placebo (every 4 weeks). Both the phase II and phase III parts will follow identical study assessments and schedules for participants. Based on an interim analysis after phase II total sample size for the trial will be defined. Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a 4-week interval. Seven days following the first IMP administration, participants will be re-evaluated for BK viremia and, if appropriate, changes of immunosuppressive treatment will be started. After administration of the final dose, participants will return as out participants for periodic safety, BK viremia, and PK follow-up assessments until the end of the trial visits, 26 weeks post last IMP application. Regular kidney biopsies will be performed at baseline (prior to infusion) and on Day 141 (8 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and as clinically indicated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BK Viremia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment Randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anti-BK polyomavirus (AntiBKV)
Arm Type
Experimental
Arm Description
1,000mg Anti-BK polyomavirus (AntiBKV) intravenous infusion every 4 weeks (4 doses)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo intravenous infusion every 4 weeks (4 doses)
Intervention Type
Biological
Intervention Name(s)
Anti-BK polyomavirus (AntiBKV)
Intervention Description
Participants in the study arm will each receive 4 doses (1,000 mg) administered at 4 weekly intervals administered on Days 1, 29, 57 and 85.
Primary Outcome Measure Information:
Title
Proportion of participants without detectable BK virus in the blood at Day 141
Description
To evaluate the therapeutic efficacy of AntiBKV in decreasing BK virus plasma concentration below the detection limit at Day 141 in Kidney Transplant Recipients (KTRs) with BK viremia and to assess the sample size for the phase III part of the study.
Time Frame
At day 141
Title
To assess whether treatment with AntiBKV decreases BK virus plasma concentration below the detection limit at day 141 in Kidney Transplant Recipients (KRTs) with BK viremia.
Description
Proportion of participants without detectable BK virus in the blood at day 141
Time Frame
At day 141
Secondary Outcome Measure Information:
Title
To assess whether treatment with AntiBKV decreases viral DNA load at Day 8 in Kidney Transplant Recipients (KTRs) with BK viremia in a clinically relevant manner.
Description
The proportion of participants with at least -1 log10 copies/mL change from baseline in BK viral DNA load at Day 8 of the placebo and AntiBKV group will be compared using the superiority by a margin test for two proportions.
Time Frame
Baseline and day 8
Title
Incidence, severity, and causal relationship of treatment-emergent adverse events (TEAEs) according to treatment group throughout the study
Description
Blood samples for safety laboratory assessments (Standard measures for hematology and chemistry) will be taken at all visits. Monitoring for injection site reactions and infusion-related reactions will be conducted as part of routine safety assessments for this study, including signs and symptoms of anaphylaxis - performed at every visit, during infusion and for at least 1 hour after infusion. Vital signs will be taken at every visit and monitored every 30 minutes after start of infusion until at least 1 hour after end of infusion.
Time Frame
Screening visit up to day 267 (+/- 14 days)
Title
Assess whether treatment with AntiBKV results in a clinically relevant decrease in viral DNA load in Kidney Transplant Recipients (KTRs) with BK viremia throughout the study
Description
Percentage and cumulative number of participants with at least -1 log10 copies/mL change from baseline in BK viral DNA load up to day 267.
Time Frame
Baseline up to day 267 (+/- 14 days)
Title
Assess renal function for Kidney Transplant Recipients (KTRs) with BK viremia throughout the study
Description
Change from baseline in renal function as measured by serum creatinine (SCr) and estimated glomerular filtration rate (e)GFR (by CKD-EPI formula) until end of follow-up.
Time Frame
Baseline through day 267 (+/- 14 days)
Title
Kidney graft lost and biopsy-confirmed BKVAN
Description
Kidney graft lost and biopsy-confirmed BKVAN will be studied by Kaplan-Meier analyses for time to event data. Percentage and cumulative number of participants with progression to BKVAN confirmed by kidney biopsies (using the Banff criteria) prior to first dose, day 141 and an optional biopsy at day 267. Percentage and cumulative incidence of participants developing clinically apparent nephropathy until end of follow-up
Time Frame
Baseline up to day 267 (+/- 14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 years or older Kidney transplantation within 24 months prior to enrollment Kidney transplant recipient with first-time BK viremia (evaluated during routine clinical monitoring by the local laboratory and acknowledged by a physician within 35 days prior to day 1). BK viremia either defined by BK virus (BKV)-DNAemia of >1,000 copies/mL sustained for three weeks (confirmed by 2 consecutive measurements 3 weeks apart), or one time >10,000 copies/mL) Kidney transplant recipients with adequate and/or stable allograft function as indicated by estimated glomerular filtration rate ((e)GFR) ≥ 30 mL/min Female subjects (if of childbearing potential) must agree to use adequate and reliable contraceptive measures throughout their participation in the trial. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Ability to provide written informed consent Exclusion Criteria: Patients with previous diagnosis of BK viremia (defined as >1,000 copies/mL sustained for three weeks (confirmed by 2 consecutive measurements 3 weeks apart), or one time >10,000 copies/mL since last kidney transplant Known hypersensitivity to any component of the investigational medicinal product (IMP) Participants with combined or multi-organ transplants Transplanted kidney disease with an estimated glomerular filtration rate ((e)GFR) < 30 mL/minute at screening Uncontrolled acute or chronic infection other than BK virus (BKV) infection at screening which might interfere with study participation at the discretion of the investigator Recipients who are treated or planned to be treated with a mammalian Target of Rapamycin (mTOR) inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the study period. Recipients who are treated or planned to be treated during study participation with leflunomide at the time of enrollment and during the study period. Recipients who in the opinion of the investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depleting therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg) Recipients with kidney transplant rejection or focal segmental glomerulosclerosis (FSGS) shown by renal biopsy Recipients who have medical conditions that prevent the recipient from undergoing allograft biopsy due to chronic anticoagulation or antiplatelet agents (except for low dose aspirin) Recipients with known donor-specific antibodies (DSA) (de novo or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (<1000 mean fluorescence intensity (MFI) can be includred if no impact on the study assessments is expected by the discretion of the investigator Recipients who are receiving a monoclonal antibody treatment for another indication (e.g. rituximab, infliximab etc.) Recipients with extremely high BK virus (BKV)-DNAemia (>10,000,000 copies/mL) or hemorrhagic cystitis Recipients who in the opinion of the investigator are likely to develop recurrent native kidney disease (e.g. immunoglobulin A [IgA] nephritis, focal segmental glomerulosclerosis [FSGS], C3 glomerulonephritis) Recipients with a functionally significant ureteral stricture Pregnant or nursing (lactating) women Current clinical, radiographic, or laboratory evidence of active or latent tuberculosis (TB) or any history, in the opinion of the investigator, that confers a risk of reactivation of latent tuberculosis (TB) and precludes the use of conventional immunosuppression History of splenectomy or asplenia Any condition, that in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of the participant safety data or study results History of malignancy within the past 5 years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least 2 years prior to screening Participation in another interventional clinical trial during trial participation or within 30 days prior to the investigational medicinal product (IMP) dosing or planned dosing History of alcoholism or drug addiction within 1 year of screening. Substance use disorder will be an exclusion criterion, at investigators discretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juergen Beck
Phone
41 44 515 9144
Email
juergen.beck@memo-therapeutics.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Parkhill
Phone
205-996-2577
Email
tparkhill@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Clifton Kew
Facility Name
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hasan Khamash
Email
Khamash.Hasan@mayo.edu
First Name & Middle Initial & Last Name & Degree
Hasan Khamash
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Kitchel
Phone
310-794-8516
Email
ekitchel@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Suphamai Bunnapradist
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Peng
Phone
310-423-2641
Email
alice.peng@cshs.org
First Name & Middle Initial & Last Name & Degree
Edmund Huang
First Name & Middle Initial & Last Name & Degree
Alice Peng
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Howes
Phone
916-734-4009
Email
khowes@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Ling-Xin Chen
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wasim Dar
Phone
860-972-4219
Email
wasim.dar@hhchealth.org
First Name & Middle Initial & Last Name & Degree
Wasim Dar
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricarda Tomlin
Phone
203-785-2073
Email
ricarda.tomlin@yale.edu
First Name & Middle Initial & Last Name & Degree
William Asch, MD, PhD
First Name & Middle Initial & Last Name & Degree
Richard Formica, MD
First Name & Middle Initial & Last Name & Degree
Abishek Kumar, MBBS
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ron Migues
Phone
202-877-2379
Email
ron.m.migues@medstar.net
First Name & Middle Initial & Last Name & Degree
Nadeshda Costa
First Name & Middle Initial & Last Name & Degree
Beje Tomas
Facility Name
Mayo Clinic Transplant Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neha Shukla
Phone
904-953-3966
Email
shukla.neha@mayo.edu
First Name & Middle Initial & Last Name & Degree
Tambi Jarmi
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Obrien
Email
sobrien5@kumc.edu
First Name & Middle Initial & Last Name & Degree
Diane Cibrik
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdolreza Hairian
Phone
410-328-5720
Email
ahariria@som.umaryland.edu
First Name & Middle Initial & Last Name & Degree
Abdolreza Hairian
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Thomas
Phone
617-643-6266
Email
mvthomas@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Hannah Gilligan
Facility Name
Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan McDermott
Phone
617-632-9810
Email
smcderm2@bidmc.harvard.edu
First Name & Middle Initial & Last Name & Degree
Martha Pavlakis
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mona Doshi
Phone
734-936-7491
Email
doshimd@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Mona Doshi
Facility Name
Washington University School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarek Alhamad
Email
talhamad@wustl.edu
First Name & Middle Initial & Last Name & Degree
Tarek Alhamad
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Tietjen
Phone
973-322-2974
Email
andrea.tietjen@rwjbh.org
First Name & Middle Initial & Last Name & Degree
Anup Patel, MD
First Name & Middle Initial & Last Name & Degree
Francis Weng, MD
First Name & Middle Initial & Last Name & Degree
Ryan Goldberg, MD
First Name & Middle Initial & Last Name & Degree
Fu Luan, MD
First Name & Middle Initial & Last Name & Degree
Praveen Kandula, MD
First Name & Middle Initial & Last Name & Degree
Navdeep Dhillon, MD
First Name & Middle Initial & Last Name & Degree
Kim Tibaldi, MD
First Name & Middle Initial & Last Name & Degree
Purna Nandigam, MD
First Name & Middle Initial & Last Name & Degree
Colleen Dowling, APN
Facility Name
New York Presbyterian Hospital - Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Bernstein
Email
ccb4001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Darshana Dadhania
Facility Name
Metrolina Nephrology Associates (MNA), PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debi Wright, MD
Phone
704-731-6910
Email
dwright@metrolinanephrology.com
First Name & Middle Initial & Last Name & Degree
Peale Chuang, MD
First Name & Middle Initial & Last Name & Degree
Matthew Elliott, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nick Baltas
Phone
216-312-3050
Email
baltasn@ccf.org
First Name & Middle Initial & Last Name & Degree
Richard Fatica
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Pesavento
Phone
614-293-4997
Email
todd.pesavento@osumc.edu
First Name & Middle Initial & Last Name & Degree
Todd Pesavento
Facility Name
University of Pennsylvania Hospital of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Sangern
Phone
800-789-7366
Email
lstacey@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Roy Bloom
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Witney Baah
Phone
214-648-8673
Email
witney.baah@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
David Wojciechowski, DO
First Name & Middle Initial & Last Name & Degree
Swee-Ling Levea, MD
First Name & Middle Initial & Last Name & Degree
Lee Anderson, III, MD
First Name & Middle Initial & Last Name & Degree
Laila Lakhani, MD
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nidhi Mehta
Phone
206-598-1562
Email
nidhim3@uw.edu
First Name & Middle Initial & Last Name & Degree
Nicolae Leca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients

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