Clinical trial NCT02377570: Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode
Official title: Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2015-03-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study investigates the performance of a new dialyzer (Theranova 400) containing a membrane with increased pore sizes. The performance will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Three different Theranova 400 prototypes (AA, BB and CC) operated in hemodialysis mode will be compared with a Cordiax FX-80 dialyzer, operated in hemodialysis mode. Safety events and albumin loss into the dialysate will be monitored


Eligibility criteria: Inclusion Criteria:

1. Patient has end-stage renal disease
2. Patient is 18 years of age or older
3. Patient is male or female
4. Patient, if female, is non-pregnant; and if capable of becoming pregnant, will be using a medically acceptable means of contraception during participation in the study (Note: Female capable of becoming pregnant \[defined as a woman less than 55 years old who has not had partial or full hysterectomy or oophorectomy\] must have a negative serum beta human chorionic gonadotropin \[β-hCG\] test within 2 weeks of first study treatment)
5. Patient has been receiving HD or HDF therapy (HDF patients are allowed if their treatments during the study can be safely and effectively performed with HD) for ≥3 months prior to study enrollment and is expected to survive for at least 12 months after enrollment
6. Patient has a stable functioning native fistula, Gore-Tex graft, or double-lumen central venous catheter capable of providing a blood flow rate of ≥280 mL/min (with an acceptable recirculation rate, such that solute removal is not likely to be affected) based on the judgment of the treating physician
7. Patient is in clinically stable condition as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing
8. Patient is willing to comply with the study requirements for therapy during the entire study treatment period
9. Patient is capable of providing written informed consent to participate in the study

Exclusion Criteria:

1. Patient is undergoing single-needle dialysis
2. Patient has an abnormal κ/λ ratio (less than 0.37, or greater than 3.1)
3. Patient has a known active infection and is currently receiving antibiotic treatment
4. Patient has known active cancer
5. Patient has a known positive serology test for human immunodeficiency virus (HIV) or hepatitis B, C or E
6. Patient has a known serious hemostasis disorder
7. Patient has a known monoclonal gammopathy (eg, monoclonal gammopathy of uncertain significance, smouldering \[asymptomatic\] multiple myeloma, symptomatic multiple myeloma, nonsecretory multiple myeloma, plasmacytomas, or plasma cell leukemia)
8. Patient has a known polyclonal gammopathy (eg, connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition)
9. Patient has any other known comorbidity that could, in the opinion of the Investigator, potentially conflict with the study purpose or procedures (eg, severe hypoalbuminemia or anemia)
10. Patient has a known significant psychiatric disorder or mental disability that could interfere with the patient's ability to provide informed consent and/or comply with protocol procedures
11. Patient has a history of non-compliance with the dialysis prescription, as assessed by the Investigator
12. Patient has participated in another interventional clinical study in the past 3 months, or is currently participating in another interventional clinical study

Primary outcomes:
measure: Overall clearance of lambda immunoglobulin free light chains (molecular weight 45 kDa)
timeFrame: One mid-week dialysis session
Secondary outcomes:
measure: Instantanous clearance of a set of molecules with molecular sizes between 60 Da and 45 kDa
timeFrame: At 30 min from start of a mid-week dialysis session
measure: Instantanous clearance of a set of molecules with molecular sizes between 60 Da and 45 kDa
timeFrame: at 120 min from start of a mid-week dialysis session
measure: Overall clearance of a set of molecules with molecular sizes between 60 Da and 40 kDa
timeFrame: One mid-week dialysis session
measure: Total mass removed of a set of molecules with molecular sizes between 60 Da and 45 kDa
timeFrame: One mid-week dialysis session
measure: Removal rate of a set of molecules with molecular sizes between 60 Da and 45 kDa
timeFrame: One mid-week dialysis session
measure: Total mass removed of albumin
timeFrame: One mid-week dialysis session
measure: Post- to pre-dialysis changes in a set of hematology parameters (blood cell counts, hematocrit and hemoglobin)
timeFrame: One mid-week dialysis session
measure: Types and frequency of adverse events and device deficiencies as a measure of safety and dialyzer tolerability
timeFrame: Continuously, from signature of informed consent form until 1 week after last hemodialysis session with an experimental or active comparator product, an expected average of 29 days
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH-Universität Klinikum Graz, Abteilung für Innere Medizin, Klinische Abteilung für Nephrologie und Dialyse
Study officials:
affiliation: Life Sciences & Operations, Gambro Dialysatoren GmbH ( a subsidiary of Baxter International Inc.)
name: Ulrike Haug, Manager
role: STUDY_DIRECTOR
References:
citation: Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.
citation: Kirsch AH, Rosenkranz AR, Lyko R, Krieter DH. Effects of Hemodialysis Therapy Using Dialyzers with Medium Cut-Off Membranes on Middle Molecules. Contrib Nephrol. 2017;191:158-167. doi: 10.1159/000479264. Epub 2017 Sep 14.