Kidney DiseasesCP026NCT04984902
Reduction of BK Viremia in Kidney Transplant Patients
A study testing Extracorporal therapy in people with Kidney Diseases and Kidney Transplant Infection, run by ExThera Medical Europe BV at 1 site in Germany.
Trial summary
Reduction of BK Viremia by treating kidney transplant patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Diseases, Kidney Transplant Infection, Kidney Transplant; Complications
- What is being tested?
- Extracorporal therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2022to 1 Apr 2023
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant patients with a BK-viraemia ≥ 10,000 IU/ml.
- Be ≥ 18 years old and ≤ 90 years old
- Existing hemodialysis access
Who cannot join
- Subject is currently participating in another clinical investigation
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
- Have Child-Pugh Class C cirrhosis
- Have platelet count <30.000/uL
- Contraindications for heparin sodium for injection
- Subjects demonstrating any contraindication for this treatment as described in the IFU
- Patients without existing hemodialysis access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of BK Viremia in Kidney Transplant Patients Using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter
Reduction of BK Viremia by treating kidney transplant patients.
Read the detailed description
a clinical investigation plan (CIP) for the "Reduction of BK viremia in kidney transplant patients using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter" clinical study, where BK is an abbreviation of the name of the first patient whom the virus was isolated from in 1971. This clinical study is intended to evaluate the reduction of BK viremia by treating kidney transplant patients with the Seraph 100 Microbind® Affinity Blood Filter from ExThera Medical. This clinical study is sponsored by ExThera Medical Corporation.
This clinical study will be conducted in accordance with this CIP. All parties involved in the conduct of the clinical study will be qualified by education, training, or experience to perform their tasks and this training will be documented appropriately.
- Being tested
- Extracorporal therapy
- Keywords
- BK Virus
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporal therapyDevice
Extracorporal therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with Microbind® Affinity Blood Filter Receives: Device: Extracorporal therapy |
| Control | No intervention | Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in log 10 viral load
Time-weighted change from baseline in log10 viral load within five days after first treatment.
Measured: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Secondary outcomes (4)
Number of participants with leukopenia
Number of participants with leukopenia
Measured: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Number of participants with increase in serum creatinine
Number of participants with increase in serum creatinine between the treatment days
Measured: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Number of participants with inoperative hypotension
Number of participants with inoperative hypotension per treatment period
Measured: At 0 and the following 3 treatments within five days after beginning with the first treatment.
Number of participants with decreasing haemoglobin measurements
Number of participants with decreasing haemoglobin measurements per treatment period
Measured: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Feb 2022 (estimated)
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Why it stopped: No participants enrolled due to logistical issues related to COVID-19 with recruiting patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The primary objective is to demonstrate the reduction of BK viremia by treating kidney transplant patients with the Seraph 100 Microbind® Affinity Blood Filter from ExThera Medical.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ExThera Medical Europe BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Essen
- Responsible party
- Sponsor
- Investigators
- Bartosz Tyczynski, Dr., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984902
- Sponsor's protocol ID
- CP026
- Acronym
- CP026
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2021
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of BK Viremia in Kidney Transplant Patients Using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter
- ClinicalTrials.gov ID
- NCT04984902
- Acronym / sponsor ID
- CP026 / CP026
- Keywords
- BK Virus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled due to logistical issues related to COVID-19 with recruiting patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ExThera Medical Europe BVIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Essen
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 2 Aug 2021 (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.
Reduction of BK Viremia by treating kidney transplant patients.
Detailed description
a clinical investigation plan (CIP) for the "Reduction of BK viremia in kidney transplant patients using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter" clinical study, where BK is an abbreviation of the name of the first patient whom the virus was isolated from in 1971. This clinical study is intended to evaluate the reduction of BK viremia by treating kidney transplant patients with the Seraph 100 Microbind® Affinity Blood Filter from ExThera Medical. This clinical study is sponsored by ExThera Medical Corporation.
This clinical study will be conducted in accordance with this CIP. All parties involved in the conduct of the clinical study will be qualified by education, training, or experience to perform their tasks and this training will be documented appropriately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The primary objective is to demonstrate the reduction of BK viremia by treating kidney transplant patients with the Seraph 100 Microbind® Affinity Blood Filter from ExThera Medical.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Extracorporal therapyTreatment with Microbind® Affinity Blood Filter |
| Control | No intervention | –Antibiotics |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Kidney transplant patients with a BK-viraemia ≥ 10,000 IU/ml.
- Be ≥ 18 years old and ≤ 90 years old
- Existing hemodialysis access
Key exclusion criteria (8 listed)
- Subject is currently participating in another clinical investigation
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
- Have Child-Pugh Class C cirrhosis
- Have platelet count <30.000/uL
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 |
|---|---|---|
| Extracorporal therapyExtracorporal therapy | Device | Treatment |
Primary outcome
Change in log 10 viral load
Time frame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Time-weighted change from baseline in log10 viral load within five days after first treatment.
4 secondary outcomes
Number of participants with leukopenia
Time frame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Number of participants with increase in serum creatinine
Time frame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Number of participants with inoperative hypotension
Time frame: At 0 and the following 3 treatments within five days after beginning with the first treatment.
Number of participants with decreasing haemoglobin measurements
Time frame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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.
Bartosz Tyczynski, Dr. principal investigator
University Hospital, Essen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporal therapy in people with Kidney Diseases and Kidney Transplant Infection, run by ExThera Medical Europe BV at 1 site in Germany.
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in log 10 viral load (time frame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.