Reduction of BK Viremia in Kidney Transplant Patients

Kidney Diseases Clinical Trial

— CP026  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04984902
• Other study ID #: CP026
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: December 2021
• Source: ExThera Medical Europe BV
• Contact: Carla Kikken-Jussen
• Phone: +31 43 8200 399
• Email: carla[@]extheramedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Reduction of BK Viremia by treating kidney transplant patients.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Extracorporal therapy
Extracorporal therapy

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen

Sponsors (2)

Lead Sponsor	Collaborator
ExThera Medical Europe BV	University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	N (%) of patients with treatment emergent adverse events	N (%) of patients with treatment emergent adverse events	2 months
Other	Laboratory data	Laboratory data (Blood test, Hematology, chemistry and coagulation)	2 months
Other	Vital signs score	Vital signs score	2 months
Other	Physical examination score	Physical examination score	2 months
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.