Reduction of BK Viremia in Kidney Transplant Patients

Study Overview
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Brief Summary
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Reduction of BK Viremia by treating kidney transplant patients.

Detailed Description
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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.

Official Title
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Reduction of BK Viremia in Kidney Transplant Patients Using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter

Conditions
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Kidney Diseases, Kidney Transplant Infection, Kidney Transplant; Complications

Intervention / Treatment
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* Device: Extracorporal therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney transplant patients with a BK-viraemia ≥ 10,000 IU/ml. Be ≥ 18 years old and ≤ 90 years old Existing hemodialysis access Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment with Microbind® Affinity Blood Filter | Device: Extracorporal therapy<br>* Extracorporal therapy<br>|
| No Intervention: Control<br>Antibiotics | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with leukopenia | 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 | Number of participants with increase in serum creatinine between the treatment days | 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 | 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 | At day 0 and the following 3 treatments within five days after beginning with the first treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BK Virus