Kidney Diseases, Kidney Transplant; Complications, Kidney Transplant Infection
Conditions
Keywords
BK Virus
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.
Interventions
DEVICEExtracorporal therapy
Extracorporal therapy
Sponsors
ExThera Medical Europe BV
University Hospital, Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORBartosz Tyczynski, Dr.
University Hospital, Essen
Outcome results
None listed