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Virus Therapy
Anti-BKV Therapy for BK Virus Infection in Kidney Transplant Patients (SAFE KIDNEY II Trial)
Phase 2 & 3
Recruiting
Research Sponsored by Memo Therapeutics AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 267 (+/- 14 days)
Awards & highlights
SAFE KIDNEY II Trial Summary
This trial evaluates the safety & efficacy of an infusion to reduce BK virus in kidney transplant recipients, with biopsies taken before & after.
Who is the study for?
This trial is for adults over 18 who've had a kidney transplant within the last 24 months and are now experiencing their first BK virus infection, with specific levels of viral DNA in their blood. They should have stable kidney function and not be on certain immunosuppressants or treatments like mTOR inhibitors or monoclonal antibodies. Pregnant women, those with recent drug addiction, or individuals with certain medical conditions that could affect the study are excluded.Check my eligibility
What is being tested?
The trial is testing AntiBKV's ability to reduce BK virus levels in kidney transplant recipients. Participants will randomly receive either AntiBKV or a placebo through an IV four times over four weeks. The study has two phases: Phase II focuses on safety and establishing proof of concept; Phase III evaluates efficacy. Kidney biopsies will be done before treatment starts and after it ends to assess impact.See study design
What are the potential side effects?
While the side effects of AntiBKV aren't fully listed here, similar drugs can cause reactions at the infusion site, changes in blood counts, fatigue, potential organ inflammation due to immune response alterations, as well as increased risk of infections.
SAFE KIDNEY II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to day 267 (+/- 14 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to day 267 (+/- 14 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants without detectable BK virus in the blood at Day 141
To assess whether treatment with AntiBKV decreases BK virus plasma concentration below the detection limit at day 141 in Kidney Transplant Recipients (KRTs) with BKV DNAemia.
Secondary outcome measures
Assess renal function for Kidney Transplant Recipients (KTRs) with BKV DNAemia throughout the study
Assess whether treatment with AntiBKV results in a clinically relevant decrease in viral DNA load in Kidney Transplant Recipients (KTRs) with BKV DNAemia throughout the study
Incidence, severity, and causal relationship of treatment-emergent adverse events (TEAEs) according to treatment group throughout the study
+2 moreSAFE KIDNEY II Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Anti-BK polyomavirus (AntiBKV)Experimental Treatment1 Intervention
1,000mg Anti-BK polyomavirus (AntiBKV) intravenous infusion every 4 weeks (4 doses)
Group II: PlaceboPlacebo Group1 Intervention
Placebo intravenous infusion every 4 weeks (4 doses)
Find a Location
Who is running the clinical trial?
Memo Therapeutics AGLead Sponsor
2 Previous Clinical Trials
72 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had my spleen removed.I have a very high BK virus count or bleeding in my bladder.My kidney transplant is working well, with a filtration rate of at least 30 mL/min.I have had BK virus in my blood since my last kidney transplant.I am currently taking or will be taking leflunomide during the study.I do not have any uncontrolled infections, except for BK virus.I agree to use reliable birth control during the trial.I have active kidney transplant rejection or FSGS confirmed by biopsy.I had a kidney transplant within the last 2 years.My kidney transplant is failing with a low filtration rate.I am being treated with, or plan to be treated with, an mTOR inhibitor or belatacept after my transplant.I haven't had cancer in the last 5 years, except for certain skin cancers or early cervical cancer.I have had a kidney transplant and now have my first BK virus infection.I am 18 years old or older.I have a significant narrowing in my ureter.I do not have active or latent TB, nor a history that increases the risk of its reactivation.I cannot have a biopsy due to my health condition or medications.
Research Study Groups:
This trial has the following groups:- Group 1: Anti-BK polyomavirus (AntiBKV)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is enrollment being accepted into this experiment?
"Affirmative. According to clinicaltrials.gov, the research study posted on April 10th 2023 is still actively recruiting patients. 180 individuals need to be enrolled in a single medical centre."
Answered by AI
Does this trial have open enrollment for participants?
"Affirmative. According to records hosted on clinicaltrials.gov, this research project is accepting participants and was first posted in April 10th 2023. It has since been updated on the 21st of April, with 180 individuals needed from one location overall."
Answered by AI
Who else is applying?
What site did they apply to?
UT Southwestern
What portion of applicants met pre-screening criteria?
Met criteria
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