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Reduction of BK Viremia in Kidney Transplant Patients (CP026)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04984902
Recruitment Status : Not yet recruiting
First Posted : August 2, 2021
Last Update Posted : December 17, 2021
Sponsor:
Collaborator:
University Hospital, Essen
Information provided by (Responsible Party):
ExThera Medical Europe BV

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

Condition or disease Intervention/treatment Phase
Kidney Diseases Kidney Transplant Infection Kidney Transplant; Complications Device: Extracorporal therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Reduction of BK Viremia in Kidney Transplant Patients Using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter
Estimated Study Start Date : February 1, 2022
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment
Treatment with Microbind® Affinity Blood Filter
Device: Extracorporal therapy
Extracorporal therapy

No Intervention: Control
Antibiotics



Primary Outcome Measures :
  1. Change in log 10 viral load [ Time Frame: 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 :
  1. Number of participants with leukopenia [ Time Frame: At day 0 and the following 3 treatments within five days after beginning with the first treatment. ]
    Number of participants with leukopenia

  2. Number of participants with increase in serum creatinine [ Time Frame: 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

  3. Number of participants with inoperative hypotension [ Time Frame: 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

  4. Number of participants with decreasing haemoglobin measurements [ Time Frame: 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


Other Outcome Measures:
  1. N (%) of patients with treatment emergent adverse events [ Time Frame: 2 months ]
    N (%) of patients with treatment emergent adverse events

  2. Laboratory data [ Time Frame: 2 months ]
    Laboratory data (Blood test, Hematology, chemistry and coagulation)

  3. Vital signs score [ Time Frame: 2 months ]
    Vital signs score

  4. Physical examination score [ Time Frame: 2 months ]
    Physical examination score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984902


Contacts
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Contact: Carla Kikken-Jussen +31 43 8200 399 carla@extheramedical.com

Locations
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Germany
University Hospital Essen
Essen, Germany
Contact: Bartosz Tyczynski, Dr.         
Contact: Kristina Boss, Dr.         
Principal Investigator: Bartosz Tyczynski, Dr.         
Sub-Investigator: Kristina Boss, Dr.         
Sponsors and Collaborators
ExThera Medical Europe BV
University Hospital, Essen
Investigators
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Principal Investigator: Bartosz Tyczynski, Dr. University Hospital, Essen
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Responsible Party: ExThera Medical Europe BV
ClinicalTrials.gov Identifier: NCT04984902    
Other Study ID Numbers: CP026
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)

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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
Keywords provided by ExThera Medical Europe BV:
BK Virus
Additional relevant MeSH terms:
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Viremia
Kidney Diseases
Urologic Diseases
Virus Diseases
Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes