Reduction of BK Viremia in Kidney Transplant Patients (CP026)

ExThera Medical

Status: Unknown

Conditions: Kidney Diseases; Kidney Transplant; Complications; Kidney Transplant Infection

Treatments: Device: Extracorporal therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04984902

CP026

Details and patient eligibility

About

Reduction of BK Viremia by treating kidney transplant patients.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Treatment

Experimental group

Description:

Treatment with Microbind® Affinity Blood Filter

Treatment:

Device: Extracorporal therapy

Control

No Intervention group

Description:

Antibiotics