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

NCT02377570 | Completed DMC

• 1 other identifier: 1407-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Instantanous clearance of a set of molecules with molecular sizes between 60 Da and 45 kDa

  At 30 min from start of a mid-week dialysis session

• Instantanous clearance of a set of molecules with molecular sizes between 60 Da and 45 kDa

  at 120 min from start of a mid-week dialysis session

• Overall clearance of a set of molecules with molecular sizes between 60 Da and 40 kDa

  One mid-week dialysis session

• Total mass removed of a set of molecules with molecular sizes between 60 Da and 45 kDa

  One mid-week dialysis session

• Removal rate of a set of molecules with molecular sizes between 60 Da and 45 kDa

  One mid-week dialysis session

Study Arms (4)

THERANOVA 400 dialyzer prototype AA

EXPERIMENTAL

THERANOVA 400 dialyzer prototype AA in hemodialysis treatment

Device: THERANOVA 400 dialyzer prototype AA

THERANOVA 400 dialyzer prototype BB

EXPERIMENTAL

THERANOVA 400 dialyzer prototype BB in hemodialysis treatment

Device: THERANOVA 400 dialyzer prototype BB

THERANOVA 400 dialyzer prototype CC

EXPERIMENTAL

THERANOVA 400 dialyzer prototype CC in hemodialysis treatment

Device: THERNOVA 400 dialyzer prototype CC

FX CorDiax 80 dialyzer

ACTIVE COMPARATOR

FX CorDiax 80 dialyzer in hemodialysis treatment

Device: FX CorDiax 80 dialyzer

Interventions

THERANOVA 400 dialyzer prototype AA DEVICE

Hemodialysis

THERANOVA 400 dialyzer prototype AA

THERANOVA 400 dialyzer prototype BB DEVICE

Hemodialysis

THERANOVA 400 dialyzer prototype BB

THERNOVA 400 dialyzer prototype CC DEVICE

Hemodialysis

THERANOVA 400 dialyzer prototype CC

FX CorDiax 80 dialyzer DEVICE

Hemodialysis

FX CorDiax 80 dialyzer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has end-stage renal disease
• Patient is 18 years of age or older
• Patient is male or female
• 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)
• 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
• 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
• 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
• Patient is willing to comply with the study requirements for therapy during the entire study treatment period
• Patient is capable of providing written informed consent to participate in the study

You may not qualify if:

• Patient is undergoing single-needle dialysis
• Patient has an abnormal κ/λ ratio (less than 0.37, or greater than 3.1)
• Patient has a known active infection and is currently receiving antibiotic treatment
• Patient has known active cancer
• Patient has a known positive serology test for human immunodeficiency virus (HIV) or hepatitis B, C or E
• Patient has a known serious hemostasis disorder
• 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)
• Patient has a known polyclonal gammopathy (eg, connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition)
• 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)
• 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
• Patient has a history of non-compliance with the dialysis prescription, as assessed by the Investigator
• Patient has participated in another interventional clinical study in the past 3 months, or is currently participating in another interventional clinical study

Sponsors & Collaborators

• Vantive Health LLC: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

LKH-Universität Klinikum Graz, Abteilung für Innere Medizin, Klinische Abteilung für Nephrologie und Dialyse

Graz, A-8036, Austria

Location

Related 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.

  PMID: 27587605 RESULT

• 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.

  PMID: 28910799 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulrike Haug, Manager

  Life Sciences & Operations, Gambro Dialysatoren GmbH ( a subsidiary of Baxter International Inc.)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: March 3, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

AU (1)