CP026: Reduction of BK Viremia in Kidney Transplant Patients

• Sponsor: ExThera Medical Europe BV (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04984902
• Collaborator: University Hospital, Essen (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.9
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated 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.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
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Treatment with Microbind® Affinity Blood Filter	Device: Extracorporal therapy; Extracorporal therapy
No Intervention: Control Antibiotics

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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

Other Outcome Measures

1. N (%) of patients with treatment emergent adverse events [2 months]

   N (%) of patients with treatment emergent adverse events

2. Laboratory data [2 months]

   Laboratory data (Blood test, Hematology, chemistry and coagulation)

3. Vital signs score [2 months]

   Vital signs score

4. Physical examination score [2 months]

   Physical examination score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Essen	Essen		Germany

Sponsors and Collaborators

• ExThera Medical Europe BV
• University Hospital, Essen

Investigators

• Principal Investigator: Bartosz Tyczynski, Dr., University Hospital, Essen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ExThera Medical Europe BV
• ClinicalTrials.gov Identifier: NCT04984902
• Other Study ID Numbers: CP026
• First Posted: Aug 2, 2021
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: Viremia; Kidney Diseases

Study Results

No Results Posted as of Dec 17, 2021