Reduction of BK Viremia in Kidney Transplant Patients

Not Applicable

• Conditions: Kidney Diseases; Kidney Transplant; Complications; Kidney Transplant Infection
• Interventions: Device: Extracorporal therapy

• Registration Number: NCT04984902
• Lead Sponsor: ExThera Medical Europe BV

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.

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-07-29
• Study First Posted: 2021-08-02
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17
• Study Start: 2022-02-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Extracorporal therapy	Treatment with Microbind® Affinity Blood Filter

Primary Outcome Measures

Name	Time	Method
Change in log 10 viral load	At day 0 and the following 3 treatments within five days after beginning with the first treatment.	Time-weighted change from baseline in log10 viral load within five days after first treatment.

Secondary Outcome Measures

Name	Time	Method
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 inoperative hypotension per treatment period
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 increase in serum creatinine between the treatment days
Number of participants with decreasing haemoglobin measurements	At day 0 and the following 3 treatments within five days after beginning with the first treatment.	Number of participants with decreasing haemoglobin measurements per treatment period
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 leukopenia

Trial Locations

Locations (1)

University Hospital Essen; 🇩🇪 Essen, Germany