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Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03257410
Recruitment Status : Completed
First Posted : August 22, 2017
Results First Posted : December 19, 2020
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Brief Summary:

The study evaluates the efficacy and safety of the Theranova 400 dialyzer compared with Elisio-17 H dialyzer in end stage renal disease patients receiving hemodialysis treatment. Efficacy will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Safety will be evaluated by maintaining pre-dialysis serum albumin levels and other safety events including laboratory tests and adverse events.

Patients will undergo 3 dialysis sessions per week, for 24 weeks.


Condition or disease Intervention/treatment Phase
End Stage Renal Disease Device: Theranova 400 dialyzer Device: Elisio-17H dialyzer Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Randomized, Controlled, Open-label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : October 27, 2018
Actual Study Completion Date : October 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Theranova 400
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Device: Theranova 400 dialyzer
Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
Other Names:
  • MCO-Ci 400 Dialyzer
  • medium cut-off dialysis membrane

Active Comparator: Elisio-17H
Three (3) dialysis sessions per week in an in-center setting over 24-week period.
Device: Elisio-17H dialyzer
Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.




Primary Outcome Measures :
  1. Reduction Ratio of Lambda Immunoglobulin FLC at Week 24 [ Time Frame: Week 24 ]
    FLC=free light chains

  2. Pre-dialysis Serum Level of Albumin at Week 24 [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24 [ Time Frame: Week 4 and Week 24 ]
    FLC=free light chains

  2. Reduction Ratio of Complement Factor D [ Time Frame: Week 4 and 24 ]
    CFD=complement factor D

  3. Reduction Ratio of κ FLC [ Time Frame: Week 4 and 24 ]
    κ FLC = Kappa Free light chains

  4. Reduction Ratio of Interleukin 6 [ Time Frame: Week 4 and 24 ]
    IL-6=interleukin 6

  5. Reduction Ratio of Tumor Necrosis Factor Alpha [ Time Frame: Week 4 and 24 ]
    TNFα=tumor necrosis factor alpha

  6. Reduction Ratio of β2-microglobulin [ Time Frame: Week 4 and 24 ]
    β2=beta 2

  7. Change From Baseline in Pre-dialysis β2-microglobulin at Week 24 [ Time Frame: Baseline, Week 24 ]
  8. Kt/Vurea [ Time Frame: Week 4, 8, 12, 16, 20, 24 ]
    Kt/Vurea = Dimensionless number used to quantify hemodialysis and peritoneal dialysis adequacy.

  9. Change From Baseline in Pre-dialysis Serum Albumin by Visit [ Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24 ]
  10. Change From Baseline in Pre-dialysis Factor VII by Visit [ Time Frame: Baseline, Week 12, Week 24 ]
  11. Change From Baseline in Pre-dialysis Protein C by Visit [ Time Frame: Baseline, Week 12, Week 24 ]
  12. Change From Baseline in Pre-dialysis Vitamin A by Visit [ Time Frame: Baseline, Week 4, Week 24 ]
  13. nPNA (nPCR) [ Time Frame: Week 4, 8, 12, 16, 20, 24 ]
    nPNA=normalized Protein equivalent of Nitrogen Appearance, and nPCR=normalized Protein Catabolic Rate.

  14. Change From Baseline in Pre-dialysis Factor II by Visit [ Time Frame: Baseline, Week 12, Week 24 ]
    Factor II (Prothrombin)

  15. Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline and Week 24 ]
  16. Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline and Week 24 ]
  17. Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  18. Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  19. Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  20. Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  21. Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  22. Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  23. Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  24. Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  25. Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  26. Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  27. Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  28. Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  29. Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  30. Change From Baseline in Platelets at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  31. Change From Baseline in Erythrocytes at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  32. Change From Baseline in Leukocytes at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  33. Change From Baseline in Basophils (%) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  34. Change From Baseline in Eosinophils (%) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  35. Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  36. Change From Baseline in Monocytes (%) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  37. Change From Baseline in Neutrophils (%) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  38. Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  39. Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  40. Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  41. Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  42. Kt/Vurea by Visit [ Time Frame: Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 ]
  43. Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  44. Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  45. Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  46. Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  47. Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  48. Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  49. Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  50. Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  51. Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  52. Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  53. Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  54. Change From Baseline in Protein (g/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  55. Change From Baseline in Globulin (g/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  56. Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  57. Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  58. Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  59. Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  60. Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  61. Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  62. Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  63. Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  64. Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  65. Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]
  66. Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24) [ Time Frame: Baseline, Week 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ESRD patients age 22 and older, or between ages 18 and 21 with a weight ≥ 40kg.
  • Clinically stable as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing.
  • Hemodialysis therapy with high-flux dialyzers for at least 3 months immediately prior to study enrollment and expected to survive for the next 12 months.
  • Expected to maintain an acceptable urea clearance (Kt/V) with a dialyzer of an approximate surface area of 1.7 m2.
  • Currently being dialyzed at an in-center setting, on a schedule of 3 times per week.
  • Able to give informed consent after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period.
  • Have a stable functioning vascular access (arteriovenous fistula, graft, or dual lumen tunneled catheter); stable access will be confirmed by observed Kt/V >= 1.2 for past 2 measurements, and/or achievement of within 15% the prescribed blood flow rate over 3 treatments prior to study entry.

Exclusion Criteria:

  • Are female and pregnant, lactating, or planning to become pregnant during the study period. Note: Female subjects of childbearing potential, defined as a woman <55 years old who has not had a partial or full hysterectomy or oophorectomy, must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test at screening. Subjects of childbearing potential must use a medically acceptable means of contraception during their participation in the study.
  • Have chronic liver disease.
  • Have a known paraprotein-associated disease.
  • Have known bleeding disorders (e.g., gastrointestinal bleed, colonic polyps, small bowel angiodysplasia, and active peptic ulcers).
  • Have had a major bleeding episode (i.e. soft tissue bleeding, blood in stool, prolonged nose bleeds, joint damage, retinal bleeding, extensive mucosal bleeding, exsanguination, cerebral hemorrhage) ≤ 12 weeks prior to randomization.
  • Have had a blood (red blood cell) transfusion ≤ 12 weeks prior to randomization.
  • Have had an acute infection ≤ 4 weeks prior to randomization.
  • Have active cancer, except for basal cell or squamous cell skin cancer.
  • Have a known serum κ/λ FLC ratio that is less than 0.37, or greater than 3.1.b
  • Have a known monoclonal gammopathy (monoclonal gammopathy of uncertain significance, smoldering [asymptomatic] multiple myeloma, symptomatic multiple myeloma, plasmacytomas, or plasma cell leukemia).
  • Have a known polyclonal gammopathy (connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition).
  • Have a positive serology test for human immunodeficiency virus or hepatitis infection.
  • Have a significant psychiatric disorder or mental disability.
  • Are scheduled for planned interventions requiring hospitalization > 1 week.
  • Are scheduled for living-donor transplantation within the study period + 3 months, plan to change to PD therapy within the next 9 months, plan to change to a home hemodialysis treatment, or plan to relocate to an area where no study center is located.
  • Are currently participating in another interventional clinical study or has participated in another interventional clinical study in the past 3 months.
  • Have a history of non-compliance with HD as assessed by an investigator.
  • Have had a major cardiovascular or cerebrovascular event within 3 months of study entry.
  • Have a history with consistent evidence of intradialytic hypotension.
  • Have uncontrolled (systolic BP > 180 mmHg) hypertension.
  • Have had adverse reactions to dialyzer materials.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257410


Locations
Show Show 20 study locations
Sponsors and Collaborators
Baxter Healthcare Corporation
  Study Documents (Full-Text)

Documents provided by Baxter Healthcare Corporation:
Study Protocol  [PDF] February 9, 2018
Statistical Analysis Plan  [PDF] November 16, 2018

Additional Information:
Publications of Results:
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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT03257410    
Other Study ID Numbers: 7905001
First Posted: August 22, 2017    Key Record Dates
Results First Posted: December 19, 2020
Last Update Posted: January 6, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency