BK Viremia; BKV DNAemiaPhase 2/3SAFE KIDNEY IINCT05769582
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients
A Phase 2/3 study testing Anti-BK polyomavirus (AntiBKV) in people with BK Viremia; BKV DNAemia, run by Memo Therapeutics AG at 23 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney transplant recipients. This study has an operationally seamless phase II/III design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BK Viremia; BKV DNAemia
- What is being tested?
- Anti-BK polyomavirus (AntiBKV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 23 sitesUnited States
- Study dates
- 10 Apr 2023to 15 Jul 2025
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or older
- Kidney transplantation within 24 months prior to enrollment
- Kidney transplant recipient with first-time BKV DNAemia (evaluated during routine clinical monitoring by the local laboratory and acknowledged by a physician within four months prior to Day 1). BKV DNAemia is either defined by BKV-DNAemia of one time >10,000 copies/mL, or >1,000 copies/mL sustained for at least one week (confirmed by two consecutive measurements. Note: The second, most recent laboratory value must be acknowledged by a physician within four months prior to Day 1)
- 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
Who cannot join
- Patients with previous diagnosis of BKV DNAemia (defined as one time > 10,000 copies/mL, or > 1,000 copies/mL sustained for at least one week (confirmed by two consecutive measurements) since last kidney transplantation
- Known hypersensitivity to any component of the IMP
- Transplanted kidney disease with an estimated glomerular filtration rate ((e)GFR) < 30 mL/minute at screening
- Uncontrolled acute or chronic infection other than 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 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
Show all 21Show fewer
- Recipients who in the opinion of the investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depletion therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg)
- Recipients with active kidney transplant rejection or FSGS
- Recipients who have medical conditions or receive concomitant medications that prevent the recipient from undergoing allograft biopsy
- Recipients with known DSA (de novo or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (< 1000 mean fluorescence intensity (MFI)) can be included if no impact on the study assessments is expected by the discretion of the investigator.
- (exclusion criterium deleted)
- Recipients with extremely high 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. IgA nephritis, FSGS, C3 glomerulonephritis)
- Recipients with a functionally significant ureteral stricture
- Pregnant or nursing (lactating) women
- Known current active or latent TB or any history, in the opinion of the investigator, that confers a risk of reactivation of latent 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 five years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least two years prior to screening
- Participation in another interventional clinical trial during trial participation or within 30 days prior to the IMP dosing or planned dosing
- History of alcoholism or drug addiction within one year of screening. Substance use disorder will be an exclusion criterion, at investigator's discretion.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
University of Maryland
Baltimore, Maryland, 21201
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Harvard Medical School
Boston, Massachusetts, 02215
Metrolina Nephrology Associates (MNA), PA
Charlotte, North Carolina, 28207
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
UT Southwestern
Dallas, Texas, 75390
Hartford Hospital
Hartford, Connecticut, 06105
Mayo Clinic Transplant Center
Jacksonville, Florida, 32224
University of Kansas Medical Center
Kansas City, Kansas, 66160
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
University of California, Los Angeles
Los Angeles, California, 90024
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Yale University School of Medicine
New Haven, Connecticut, 06520
New York Presbyterian Hospital - Weill Cornell Medical Center
New York, New York, 10065
University of Pennsylvania Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Phoenix, Arizona, 85054
University of California Davis
Sacramento, California, 95817
University of Washington Medical Center
Seattle, Washington, 98195
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
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
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney transplant recipients. This study has an operationally seamless phase II/III design. The phase II part will evaluate the safety of AntiBKV in kidney transplant recipients and establish antiviral proof of concept. The phase II part includes a dose-comparison part to generate additional PK and PD data of AntiBKV. The phase III part will assess the efficacy of AntiBKV in kidney transplant recipients. 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 four weeks). In phase II, 60 participants will be first randomized (1:1) to receive either four doses of 1,000 mg of AntiBKV or placebo. In an additional dose-comparison extension, another 30 participants will be enrolled and randomized (1:1:1) to receive either four doses of 1,000 mg AntiBKV, four doses of 500 mg AntiBKV, or placebo. Based on a Day 141 analysis after phase II the sample size for the phase III part of the trial will be defined. Both the phase II and phase III parts will follow identical study assessments and schedules for participants.
Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a four-week interval. For the first ten participants enrolled in the study, the infusion time will be at least 60 minutes. Provided there are no safety concerns observed with the first ten participants the duration of subsequent infusions will be at least 30 minutes.
After administration of the final dose, participants will return as out participants for periodic safety, BKV DNAemia, 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 if clinically indicated.
- Conditions
- BK Viremia; BKV DNAemia
- Being tested
- Anti-BK polyomavirus (AntiBKV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-BK polyomavirus (AntiBKV)Biological
Participants in the study arm will each receive four doses (1,000 mg; 1,000 mg or 500 mg in the dose comparison part) of IMP administered at four-week intervals.
IMP will be administered on Days 1, 29, 57 and 85.
| Study group | Role | What they receive |
|---|---|---|
| Anti-BK polyomavirus (AntiBKV) | Experimental | 1,000mg or 500mg Anti-BK polyomavirus (AntiBKV) per intravenous infusion every four weeks (four doses) Receives: Biological: Anti-BK polyomavirus (AntiBKV) |
| Placebo | Placebo comparator | Placebo intravenous infusion every 4 weeks (4 doses) Receives: Biological: Anti-BK polyomavirus (AntiBKV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with undetectable BKV DNAemia in the blood at Day 141 (Phase II)
To evaluate the therapeutic efficacy of AntiBKV in decreasing BKV DNAemia to undetectable (< Lower Limit of Quantification (LLOQ), target not detected) at Day 141 in Kidney Transplant Recipients with BKV DNAemia and to assess the sample size for the phase III part of the study
Measured: At Day 141
Proportion of participants with undetectable BKV DNAemia at Day 141 (Phase III)
To assess whether treatment with AntiBKV decreases BKV DNAemia to undetectable (< LLOQ, target not detected) at Day 141 in Kidney Transplant Recipients with BKV DNAemia
Measured: At Day 141
Secondary outcomes (8)
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.
Measured: Screening visit up to Day 267 (+/- 14 days)
Absolute change from baseline in BKV DNAemia over time through Day 141
Assessment whether treatment with AntiBKV results in a clinically relevant decrease in BKV DNAemia through Day 141.
Measured: Baseline and up to Day 141
The time to undetectable BKV DNAemia (< LLOQ, target not detected) through Day 141
Assessment whether treatment with AntiBKV decreases BKV DNAemia and shortens the time to undetectable (< LLOQ, target not detected) through Day 141
Measured: Baseline and up to Day 141
Proportion of participants with undetectable (< LLOQ, target not detected) BKV DNAemia AND absence of progressing BKVAN (evaluated in kidney biopsies using the Banff criteria) at Day 141
Assessment whether treatment with AntiBKV decreases BKV DNAemia to undetectable (< LLOQ, target not detected) AND prevents progression of BKVAN at Day 141
Measured: Baseline and up to Day 141
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Estimation of the following PK parameter post-administration of four doses of 1,000 mg or 500 mg AntiBKV to kidney transplant recipients:
- Trough Serum Concentration (Ctrough)
Measured: Baseline up to Day 267 (+/- 14 days)
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Estimation of the following PK parameter post-administration of four doses of 1,000 mg or 500 mg AntiBKV to kidney transplant recipients:
- Maximum Serum Concentration and accumulation ratio between first and last dose (Cmax)
Measured: Baseline up to Day 267 (+/- 14 days)
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Estimation of the following PK parameter post-administration of four doses of 1,000 mg or 500 mg AntiBKV to kidney transplant recipients:
- Area Under the Concentration-time Curve (AUC)
Measured: Baseline up to Day 267 (+/- 14 days)
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Estimation of the following PK parameter post-administration of four doses of 1,000 mg or 500 mg AntiBKV to kidney transplant recipients:
Clearance (CL)
Measured: Baseline up to Day 267 (+/- 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start10 Apr 2023
- Primary completion19 Mar 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BK Viremia; BKV DNAemiaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment Randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memo Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769582
- Sponsor's protocol ID
- MTx-AntiBKV-US-2.01BKVI
- Acronym
- SAFE KIDNEY II
- Status last verified
- Sep 2025
- First submitted
- 3 Mar 2023
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wojciechowski D, Kotton CN. BK Nephropathy in the Modern Era: What Have We Learned? Kidney360. 2025 Dec 1;6(12):2257-2262. doi: 10.34067/KID.0000000967. Epub 2025 Aug 19.
PubMed 40828617Weber M, Schmitt S, Eicher B, Seidenberg J, Rutkauskaite J, Stockli B, Townsend C, Huynh-Do U, Schachtner T, Delbue S, Mader A, Esslinger C, Hillenbrand M. A highly potent human antibody neutralizing all serotypes of BK polyomavirus. PLoS Pathog. 2025 Jul 18;21(7):e1013122. doi: 10.1371/journal.ppat.1013122. eCollection 2025 Jul.
PubMed 40680077Helle F, Aubry A, Morel V, Descamps V, Demey B, Brochot E. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients. J Am Soc Nephrol. 2024 Oct 1;35(10):1425-1433. doi: 10.1681/ASN.0000000000000457. Epub 2024 Jul 9.
PubMed 39352862
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05769582
- Acronym / sponsor ID
- SAFE KIDNEY II / MTx-AntiBKV-US-2.01BKVI
- Conditions
- BK Viremia; BKV DNAemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Memo Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 15 Mar 2023 (actual)
- 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 purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BKV DNAemia and progression to biopsy-confirmed BKVAN in kidney transplant recipients. This study has an operationally seamless phase II/III design. The phase II part will evaluate the safety of AntiBKV in kidney transplant recipients and establish antiviral proof of concept. The phase II part includes a dose-comparison part to generate additional PK and PD data of AntiBKV. The phase III part will assess the efficacy of AntiBKV in kidney transplant recipients. 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 four weeks). In phase II, 60 participants will be first randomized (1:1) to receive either four doses of 1,000 mg of AntiBKV or placebo. In an additional dose-comparison extension, another 30 participants will be enrolled and randomized (1:1:1) to receive either four doses of 1,000 mg AntiBKV, four doses of 500 mg AntiBKV, or placebo. Based on a Day 141 analysis after phase II the sample size for the phase III part of the trial will be defined. Both the phase II and phase III parts will follow identical study assessments and schedules for participants.
Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a four-week interval. For the first ten participants enrolled in the study, the infusion time will be at least 60 minutes. Provided there are no safety concerns observed with the first ten participants the duration of subsequent infusions will be at least 30 minutes.
After administration of the final dose, participants will return as out participants for periodic safety, BKV DNAemia, 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 if clinically indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment Randomized
| Arm | Type | Receives |
|---|---|---|
| Anti-BK polyomavirus (AntiBKV) | Experimental | Biological: Anti-BK polyomavirus (AntiBKV)1,000mg or 500mg Anti-BK polyomavirus (AntiBKV) per intravenous infusion every four weeks (four doses) |
| Placebo | Placebo comparator | Biological: Anti-BK polyomavirus (AntiBKV)Placebo intravenous infusion every 4 weeks (4 doses) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged 18 years or older
- Kidney transplantation within 24 months prior to enrollment
- Kidney transplant recipient with first-time BKV DNAemia (evaluated during routine clinical monitoring by the local laboratory and acknowledged by a physician within four months prior to Day 1). BKV DNAemia is either defined by BKV-DNAemia of one time >10,000 copies/mL, or >1,000 copies/mL sustained for at least one week (confirmed by two consecutive measurements. Note: The second, most recent laboratory value must be acknowledged by a physician within four months prior to Day 1)
- 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
Key exclusion criteria (21 listed)
- Patients with previous diagnosis of BKV DNAemia (defined as one time > 10,000 copies/mL, or > 1,000 copies/mL sustained for at least one week (confirmed by two consecutive measurements) since last kidney transplantation
- Known hypersensitivity to any component of the IMP
- Transplanted kidney disease with an estimated glomerular filtration rate ((e)GFR) < 30 mL/minute at screening
- Uncontrolled acute or chronic infection other than 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 mTOR inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the study period
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 |
|---|---|---|
| Anti-BK polyomavirus (AntiBKV)Participants in the study arm will each receive four doses (1,000 mg; 1,000 mg or 500 mg in the dose comparison part) of IMP administered at four-week intervals. IMP will be administered on Days 1, 29, 57 and 85. | Biological | Anti-BK polyomavirus (AntiBKV), Placebo |
Primary outcome
Proportion of participants with undetectable BKV DNAemia in the blood at Day 141 (Phase II)
Time frame: At Day 141
To evaluate the therapeutic efficacy of AntiBKV in decreasing BKV DNAemia to undetectable (< Lower Limit of Quantification (LLOQ), target not detected) at Day 141 in Kidney Transplant Recipients with BKV DNAemia and to assess the sample size for the phase III part of the study
Proportion of participants with undetectable BKV DNAemia at Day 141 (Phase III)
Time frame: At Day 141
To assess whether treatment with AntiBKV decreases BKV DNAemia to undetectable (< LLOQ, target not detected) at Day 141 in Kidney Transplant Recipients with BKV DNAemia
8 secondary outcomes
Incidence, severity, and causal relationship of treatment-emergent adverse events (TEAEs) according to treatment group throughout the study
Time frame: Screening visit up to Day 267 (+/- 14 days)
Absolute change from baseline in BKV DNAemia over time through Day 141
Time frame: Baseline and up to Day 141
The time to undetectable BKV DNAemia (< LLOQ, target not detected) through Day 141
Time frame: Baseline and up to Day 141
Proportion of participants with undetectable (< LLOQ, target not detected) BKV DNAemia AND absence of progressing BKVAN (evaluated in kidney biopsies using the Banff criteria) at Day 141
Time frame: Baseline and up to Day 141
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Time frame: Baseline up to Day 267 (+/- 14 days)
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Time frame: Baseline up to Day 267 (+/- 14 days)
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Time frame: Baseline up to Day 267 (+/- 14 days)
To describe the pharmacokinetics (PKs) of AntiBKV with the doses of 1,000 mg and 500 mg in kidney transplant recipients with BKV DNAemia
Time frame: Baseline up to Day 267 (+/- 14 days)
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 29 Sep 2025.
- Derived from this study: PubMed 40828617Wojciechowski D, Kotton CN. BK Nephropathy in the Modern Era: What Have We Learned? Kidney360. 2025 Dec 1;6(12):2257-2262. doi: 10.34067/KID.0000000967. Epub 2025 Aug 19.
- Derived from this study: PubMed 40680077Weber M, Schmitt S, Eicher B, Seidenberg J, Rutkauskaite J, Stockli B, Townsend C, Huynh-Do U, Schachtner T, Delbue S, Mader A, Esslinger C, Hillenbrand M. A highly potent human antibody neutralizing all serotypes of BK polyomavirus. PLoS Pathog. 2025 Jul 18;21(7):e1013122. doi: 10.1371/journal.ppat.1013122. eCollection 2025 Jul.
- Derived from this study: PubMed 39352862Helle F, Aubry A, Morel V, Descamps V, Demey B, Brochot E. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients. J Am Soc Nephrol. 2024 Oct 1;35(10):1425-1433. doi: 10.1681/ASN.0000000000000457. Epub 2024 Jul 9.
- Individual participant dataSharing planned: No
Related trials for BK Viremia; BKV DNAemia
RecruitingObservational study
Study of the Serotype and Genotype of BK Virus in Kidney Transplant Recipients and Their Donors to Identify Individuals at Risk of Nephropathy
Nephropathy, Opportunistic Viral Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anti-BK polyomavirus (AntiBKV) in people with BK Viremia; BKV DNAemia, run by Memo Therapeutics AG at 23 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 6 inclusion and 21 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of participants with undetectable BKV DNAemia in the blood at Day 141 (Phase II) (time frame: At Day 141). The study lists 2 primary outcomes in all. 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 NCT05769582, which also lists 3 linked publications.
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 29 Sep 2025.