Reduction of BK Viremia in Kidney Transplant Patients

NCT04984902 | Withdrawn

• 1 other identifier: CP026
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Reduction of BK Viremia by treating kidney transplant patients.

Conditions

Kidney Diseases; Kidney Transplant Infection; Kidney Transplant; Complications

Keywords

BK Virus

Outcome Measures

Primary Outcomes (1)

• Change in log 10 viral load

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

  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

  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

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

• Number of participants with inoperative hypotension

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

• Number of participants with decreasing haemoglobin measurements

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

Other Outcomes (4)

• N (%) of patients with treatment emergent adverse events

  2 months

• Laboratory data

  2 months

• Vital signs score

  2 months

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment with Microbind® Affinity Blood Filter

Device: Extracorporal therapy

Control

NO INTERVENTION

Antibiotics

Interventions

Extracorporal therapy DEVICE

Extracorporal therapy

Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ExThera Medical Europe BV: lead
• University Hospital, Essen: collaborator

Study Sites (1)

University Hospital Essen

Essen, Germany

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Bartosz Tyczynski, Dr.

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: August 2, 2021
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

DE (1)