Reduction of BK Viremia by treating kidney transplant patients.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Extracorporal therapy
University Hospital Essen
Essen, Germany
Change in log 10 viral load
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.
Number of participants with leukopenia
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 increase in serum creatinine
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.
Number of participants with inoperative hypotension
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.
Number of participants with decreasing haemoglobin measurements
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.
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