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Reduction of BK Viremia in Kidney Transplant Patients (CP026)

Primary Purpose

Kidney Diseases, Kidney Transplant Infection, Kidney Transplant; Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Extracorporal therapy
Sponsored by
ExThera Medical Europe BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring BK Virus

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Essen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

Treatment with Microbind® Affinity Blood Filter

Antibiotics

Outcomes

Primary Outcome Measures

Change in log 10 viral load
Time-weighted change from baseline in log10 viral load within five days after first treatment.

Secondary Outcome Measures

Number of participants with leukopenia
Number of participants with leukopenia
Number of participants with increase in serum creatinine
Number of participants with increase in serum creatinine between the treatment days
Number of participants with inoperative hypotension
Number of participants with inoperative hypotension per treatment period
Number of participants with decreasing haemoglobin measurements
Number of participants with decreasing haemoglobin measurements per treatment period

Full Information

First Posted
April 21, 2021
Last Updated
December 16, 2021
Sponsor
ExThera Medical Europe BV
Collaborators
University Hospital, Essen
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1. Study Identification

Unique Protocol Identification Number
NCT04984902
Brief Title
Reduction of BK Viremia in Kidney Transplant Patients
Acronym
CP026
Official Title
Reduction of BK Viremia in Kidney Transplant Patients Using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ExThera Medical Europe BV
Collaborators
University Hospital, Essen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Kidney Transplant Infection, Kidney Transplant; Complications
Keywords
BK Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treatment with Microbind® Affinity Blood Filter
Arm Title
Control
Arm Type
No Intervention
Arm Description
Antibiotics
Intervention Type
Device
Intervention Name(s)
Extracorporal therapy
Intervention Description
Extracorporal therapy
Primary Outcome Measure Information:
Title
Change in log 10 viral load
Description
Time-weighted change from baseline in log10 viral load within five days after first treatment.
Time Frame
At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Secondary Outcome Measure Information:
Title
Number of participants with leukopenia
Description
Number of participants with leukopenia
Time Frame
At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Title
Number of participants with increase in serum creatinine
Description
Number of participants with increase in serum creatinine between the treatment days
Time Frame
At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Title
Number of participants with inoperative hypotension
Description
Number of participants with inoperative hypotension per treatment period
Time Frame
At 0 and the following 3 treatments within five days after beginning with the first treatment.
Title
Number of participants with decreasing haemoglobin measurements
Description
Number of participants with decreasing haemoglobin measurements per treatment period
Time Frame
At day 0 and the following 3 treatments within five days after beginning with the first treatment.
Other Pre-specified Outcome Measures:
Title
N (%) of patients with treatment emergent adverse events
Description
N (%) of patients with treatment emergent adverse events
Time Frame
2 months
Title
Laboratory data
Description
Laboratory data (Blood test, Hematology, chemistry and coagulation)
Time Frame
2 months
Title
Vital signs score
Description
Vital signs score
Time Frame
2 months
Title
Physical examination score
Description
Physical examination score
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Kikken-Jussen
Phone
+31 43 8200 399
Email
carla@extheramedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bartosz Tyczynski, Dr.
Organizational Affiliation
University Hospital, Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Essen
City
Essen
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bartosz Tyczynski, Dr.
First Name & Middle Initial & Last Name & Degree
Kristina Boss, Dr.
First Name & Middle Initial & Last Name & Degree
Bartosz Tyczynski, Dr.
First Name & Middle Initial & Last Name & Degree
Kristina Boss, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Reduction of BK Viremia in Kidney Transplant Patients

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