Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode

End Stage Renal Disease Clinical Trial

Official title:

Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377570
• Other study ID #: 1407-003
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: May 2015

Study information

• Verified date: February 2022
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 [ß-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 ?/? 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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• THERANOVA 400 dialyzer prototype AA
Hemodialysis
• THERANOVA 400 dialyzer prototype BB
Hemodialysis
• THERNOVA 400 dialyzer prototype CC
Hemodialysis
• FX CorDiax 80 dialyzer
Hemodialysis

Locations

Country	Name	City	State
Austria	LKH-Universität Klinikum Graz, Abteilung für Innere Medizin, Klinische Abteilung für Nephrologie und Dialyse	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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. Erra — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall clearance of lambda immunoglobulin free light chains (molecular weight 45 kDa)	The primary efficacy endpoint is the overall clearance of lambda immunoglobulin free light chains during a mid-week hemodialysis session, assessed once with each experimental and active comparator product	One mid-week dialysis session
Secondary	Instantanous clearance of a set of molecules with molecular sizes between 60 Da and 45 kDa	One secondary efficacy endpoint is the instantaneous clearance of a set of molecules with molecular sizes from 60 Da to 45 kDa at 30 min after start of a mid-week hemodialysis session, assessed once with each experimental and active comparator product	At 30 min from start of a mid-week dialysis session
Secondary	Instantanous clearance of a set of molecules with molecular sizes between 60 Da and 45 kDa	One secondary efficacy endpoint is the instantaneous clearance of a set of molecules with molecular sizes from 60 Da to 45 kDa at 120 min after start of a mid-week hemodialysis session, assessed once with each experimental and active comparator product	at 120 min from start of a mid-week dialysis session
Secondary	Overall clearance of a set of molecules with molecular sizes between 60 Da and 40 kDa	One secondary efficacy endpoint is the overall clearance of a set of molecules from 60 Da to 40 kDa during one mid-week hemodialysis session, assessed once with each experimental and active comparator product	One mid-week dialysis session
Secondary	Total mass removed of a set of molecules with molecular sizes between 60 Da and 45 kDa	One secondary efficacy endpoint is the total mass removed of a set of molecules from 60 Da to 45 kDa during one mid-week hemodialysis session, assessed once with each experimental and active comparator product	One mid-week dialysis session
Secondary	Removal rate of a set of molecules with molecular sizes between 60 Da and 45 kDa	One secondary efficacy endpoint is the removal rate of a set of molecules from 60 Da to 45 kDa during one mid-week hemodialysis session, assessed once with each experimental and active comparator product	One mid-week dialysis session
Secondary	Total mass removed of albumin	One secondary safety endpoint is the total removed mass of albumin during one mid-week hemodialysis session, assessed once with each experimental and active comparator product	One mid-week dialysis session
Secondary	Post- to pre-dialysis changes in a set of hematology parameters (blood cell counts, hematocrit and hemoglobin)	One secondary safety endpoint is the change in hematology parameters during one mid-week hemodialysis session, assessed once with each experimental and active comparator product	One mid-week dialysis session
Secondary	Types and frequency of adverse events and device deficiencies as a measure of safety and dialyzer tolerability	Any adverse events and device deficiencies will be recorded.	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