NCT04984902

Reduction of BK Viremia in Kidney Transplant Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: ExThera Medical Europe BV · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Diseases
• Kidney Transplant Infection
• Kidney Transplant; Complications

Interventions

Type	Name	Description
DEVICE	Extracorporal therapy	Extracorporal therapy

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-02-01
• Completion: 2023-04-01
• First posted: 2021-08-02
• Last updated: 2021-12-17

Locations

1 site across 1 country: Germany