Clinical trial NCT04984902: Reduction of BK Viremia in Kidney Transplant Patients
Official title: Reduction of BK Viremia in Kidney Transplant Patients Using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Diseases
Kidney Transplant Infection
Kidney Transplant; Complications
Keywords: BK Virus
Lead sponsor: ExThera Medical Europe BV
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Essen
First posted: 2021-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Change in log 10 viral load
timeFrame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Secondary outcomes:
measure: Number of participants with leukopenia
timeFrame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
measure: Number of participants with increase in serum creatinine
timeFrame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
measure: Number of participants with inoperative hypotension
timeFrame: At 0 and the following 3 treatments within five days after beginning with the first treatment.
measure: Number of participants with decreasing haemoglobin measurements
timeFrame: At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Other outcomes:
measure: N (%) of patients with treatment emergent adverse events
timeFrame: 2 months
measure: Laboratory data
timeFrame: 2 months
measure: Vital signs score
timeFrame: 2 months
measure: Physical examination score
timeFrame: 2 months
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
Study officials:
affiliation: University Hospital, Essen
name: Bartosz Tyczynski, Dr.
role: PRINCIPAL_INVESTIGATOR
References: