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WithdrawnNCT04984902CP026Updated Apr 20, 2026

Reduction of BK Viremia in Kidney Transplant Patients

An interventional study of Extracorporal therapy in Kidney Diseases, Kidney Transplant Infection and Kidney Transplant; Complications, sponsored by ExThera Medical Europe BV. Withdrawn at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by ExThera Medical Europe BV · Not applicable, Interventional, and Treatment

Why this study was withdrawn
No participants enrolled due to logistical issues related to COVID-19 with recruiting patients.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Kidney Diseases
  • Kidney Transplant Infection
  • Kidney Transplant; Complications

Browse trials for

Keywords

  • BK Virus
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

Browse Kidney Diseases studies →

Lead sponsor

ExThera Medical Europe BV is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Kidney transplant patients with a BK-viraemia ≥ 10,000 IU/ml.
  2. Be ≥ 18 years old and ≤ 90 years old
  3. Existing hemodialysis access

Exclusion criteria

Exclusion Criteria:

  1. Subject is currently participating in another clinical investigation
  2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
  3. 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
  4. Have Child-Pugh Class C cirrhosis
  5. Have platelet count \<30.000/uL
  6. Contraindications for heparin sodium for injection
  7. Subjects demonstrating any contraindication for this treatment as described in the IFU
  8. Patients without existing hemodialysis access
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Treatment

    Treatment with Microbind® Affinity Blood Filter

    Device: Extracorporal therapy

  • No intervention
    Control

    Antibiotics

Interventions

  • DeviceExtracorporal therapy

    Extracorporal therapy

06

What researchers measure

Primary outcomes

  1. Change in log 10 viral load

    Time-weighted change from baseline in log10 viral load within five days after first treatment.

    Time frame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.

Secondary outcomes

  1. Number of participants with leukopenia

    Number of participants with leukopenia

    Time frame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.

  2. Number of participants with increase in serum creatinine

    Number of participants with increase in serum creatinine between the treatment days

    Time frame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.

  3. Number of participants with inoperative hypotension

    Number of participants with inoperative hypotension per treatment period

    Time frame: At 0 and the following 3 treatments within five days after beginning with the first treatment.

  4. Number of participants with decreasing haemoglobin measurements

    Number of participants with decreasing haemoglobin measurements per treatment period

    Time frame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.

Other outcomes

  1. N (%) of patients with treatment emergent adverse events

    N (%) of patients with treatment emergent adverse events

    Time frame: 2 months

  2. Laboratory data

    Laboratory data (Blood test, Hematology, chemistry and coagulation)

    Time frame: 2 months

  3. Vital signs score

    Vital signs score

    Time frame: 2 months

  4. Physical examination score

    Physical examination score

    Time frame: 2 months

07

Study locations

1 site
  • University Hospital Essen
    Essen, Germany
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04984902
Lead sponsor
ExThera Medical Europe BV
Collaborators
University Hospital, Essen
Responsible party
Sponsor
First posted
Aug 2, 2021
Start date
Feb 1, 2022 (estimated)
Primary completion
Feb 1, 2023 (estimated)
Completion
Apr 1, 2023 (estimated)
Last update
Apr 20, 2026

Study contacts

Bartosz Tyczynski, Dr.
principal investigator · University Hospital, Essen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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