Back to results

Clearum High Flux Hemodialyzer Used in Hemodialysis for Subjects With End-Stage Renal Disease

Primary Purpose

End-stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Clearum HF Hemodialyzer

About this trial

This is an interventional treatment trial for End-stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

ESRD Patients aged 18 years or older
Patients able to give informed consent (IC) and interested to participate in the study
Stable (according to the investigator) on hemodialysis for more than 3 months with previous treatments of 3x weekly hemodialysis or hemodiafiltration
Stable hemoglobin between 10 and 12 g/dl in the most recent two consecutive blood draws
Stable anticoagulation and ESA regimen with no dosing modifications in the past 1 month
Patients who have an adequate AVF or graft, capable of providing a blood flow rate of at least 300 mL/min according to sessions conducted in past month

Exclusion Criteria:

Patients who have acute renal failure with the chance for recovery.
Patients who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to PD within the next two months or who require single needle dialysis therapy.
Pregnant and lactating women.
Patients with a history of positive serology tests for Hepatitis B surface antigen, positive Hepatitis C total antibody, HIV and syphilis.
Patients with known hemodynamic instability, anemia (Hgb < 90 g/L), and/or severe bleeding risks secondary to coagulation disorders.
Patients with active or ongoing infection per investigator's judgement.
Patients with a history of solid tumors requiring anti-cancer therapy in the past or next 6 months or a life expectancy less than 1 year or patients with a history of a hematology neoplasm.
Patients diagnosed with a NYHA Class IV congestive heart failure, or acute coronary syndrome and/or who have suffered a myocardial infarction within three months prior to the start of the study.
Patients with a history of severe mental disorders.
Patients who are currently participating or have previously participated in another interventional clinical trial in the past 4 weeks.
Patients who have had an allergic response to polyarylethersulfone (PAES) or polysulfone membranes or have a history of poor tolerance to dialyzers with synthetic membranes.
Patients with advanced liver, heart or pulmonary disease as judged by the Investigator
Patients with any comorbidity possibly conflicting with the study purpose or procedures as judged by the Investigator.

Sites / Locations

DaVita Clinical Research Germany

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clearum HF Dialysis Subjects

Arm Description

All subjects enrolled in the study and treated with the Clearum HF hemodialyzer

Outcomes

Primary Outcome Measures

Evaluate performance of small-solute (toxin) removal

The primary objective of this study is to evaluate performance of small-solute (toxin) removal, represented by urea, under standard high flux hemodialysis conditions with a mean urea reduction ratio (URR) of 65% or greater.

Secondary Outcome Measures

Adverse Events

Evaluate of all adverse events during the study period

B2M reduction ratio

Evaluate performance of the B2M reduction ratio

Instantaneous clearance of B2M during specified time-points

Evaluate the instantaneous clearance of B2M for the Clearum HS dialyzer at 15-30 min and at 120-150 min at session the mid-week session of week 2 with the Clearum dialyzer.

Reduction ratio of albumin during hemodialysis

Evaluate the reduction ratio of albumin during the hemodialysis session with the Clearum dialyzer and any trends in albumin concentration over a 6-week period

Follow-up of CRP for patients treated with Clearum dialyzer

Observe the trends in inflammatory markers CRP over a 6-week period

Follow-up of IL6 for patients treated with Clearum dialyzer

Observe the trends in inflammatory markers IL6 over a 6-week period

Evaluation of TAT (Thrombin-antithrombin) complex

Evaluate coagulation parameters as assessed by Thrombin-anti-thrombin (TAT) on the dialyzer after blood restitution at the end of the dialytic session for sessions where sampling occurs

Quality of rinse-back (filter and circuit) via a visual scale

Evaluate on a qualitative photo visual score ranging from poor to very good (1-5) for the residual blood remaining in the dialyzer after rinse back at the end of the session

Full Information

NCT ID

NCT04395131

First Posted

April 30, 2020

Last Updated

August 31, 2020

Sponsor

Medtronic - MITG

1. Study Identification

Unique Protocol Identification Number

NCT04395131

Brief Title

Clearum High Flux Hemodialyzer Used in Hemodialysis for Subjects With End-Stage Renal Disease

Official Title

Clearum High Flux Hemodialyzer: Safety and Performance Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

April 3, 2020 (Actual)

Primary Completion Date

August 14, 2020 (Actual)

Study Completion Date

August 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic - MITG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study will be a prospective, interventional, non-randomized, single-center study in 20 ESRD patients on hemodialysis. The study will compare performance of the Clearum HS dialyzer to typical values obtained with other commercially available high flux dialyzers. In addition, the Clearum HS dialyzer will be compared to a Fresenius FX80 dialyzer for a baseline (control) comparison. This will be a post-market study. The duration of the trial is 2 weeks for the FX80 control dialyzer + 6 weeks with the Clearum HS dialyzer used for 3x weekly high flux hemodialysis.

Detailed Description

The study will compare performance to typical values obtained with commercially available dialyzers used for high flux hemodialysis and comparing the Clearum HS dialyzer to the baseline values of a control FX80 Dialyzer. The duration of the trial is 2 weeks for the FX80 control dialyzer + 6 weeks with the Clearum HS dialyzer used for 3x weekly high flux hemodialysis. The sampling, reported in Table 1 below, will be done at mid-week sessions (pre and post session sampling) and consists of a blood draw for baseline dialysis with the FX80 weeks 1 and 2, or Clearum HS dialyzer at weeks 3, 5 and 8 for uremic toxins: urea, creatinine, phosphate, B2-microglobulin, albumin, sodium, potassium, calcium, magnesium, platelets and leucocytes, and platelets. In addition, a presession sample will be taken for coagulation parameter TAT, hematocrit and inflammatory markers IL6 and C reactive protein at baseline for FX80 at mid-week sessions during weeks 1 and 2 and during weeks 3, 5 and 8 for the Clearum HS dialyzer. Instantaneous B2M clearance sampling will be done at week 7 during the Clearum HS dialyzer phase and consists of a blood sample prior to the dialyzer and immediately after the dialyzer at two time points, 15-30 min and at 120-150 min, respectively. Blood rest will be done by comparing the dialyzer to a set of 5 illustrations and giving a score of 1 (worst) to 5 (best) that best correlates the dialyzer with the illustration, at the end of the dialysis session after blood has been returned to the patients (both FX80 and Clearum HS) on the sampling days. The patients will be treated for 2 weeks with a standard dialyzer (FX80) and an additional 6 weeks with the Clearum HS dialyzer (experimental period). Both hemodialyzers will be used for 3 times a week. Expected duration for the study including enrolment will be 3 months. The study duration will be approximately 3-4 months. Each patient will receive 6 hemodialysis sessions with FX80 and 18 sessions with Clearum HS hemodialyzer, and the treatment time will be between 3.5 and 4.5 hours

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End-stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clearum HF Dialysis Subjects

Arm Type

Other

Arm Description

All subjects enrolled in the study and treated with the Clearum HF hemodialyzer

Intervention Type

Device

Intervention Name(s)

Clearum HF Hemodialyzer

Intervention Description

the hemodialyzer will be used 3x week for 3.5-4.5 hours with a Qb of at least 350 ml/min

Primary Outcome Measure Information:

Title

Evaluate performance of small-solute (toxin) removal

Description

Time Frame

End of dialysis treatment

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Evaluate of all adverse events during the study period

Time Frame

8 weeks, 3 sessions per week

Title

B2M reduction ratio

Description

Evaluate performance of the B2M reduction ratio

Time Frame

5 sampling at mid-week session of week 1, 2, 3, 5 and 8

Title

Instantaneous clearance of B2M during specified time-points

Description

Evaluate the instantaneous clearance of B2M for the Clearum HS dialyzer at 15-30 min and at 120-150 min at session the mid-week session of week 2 with the Clearum dialyzer.

Time Frame

1 sampling at mid-week session of week 7

Title

Reduction ratio of albumin during hemodialysis

Description

Evaluate the reduction ratio of albumin during the hemodialysis session with the Clearum dialyzer and any trends in albumin concentration over a 6-week period

Time Frame

5 sampling at mid-week session of week 1, 2, 3, 5 and 8

Title

Follow-up of CRP for patients treated with Clearum dialyzer

Description

Observe the trends in inflammatory markers CRP over a 6-week period

Time Frame

Kinetic over 6 week period

Title

Follow-up of IL6 for patients treated with Clearum dialyzer

Description

Observe the trends in inflammatory markers IL6 over a 6-week period

Time Frame

Kinetic over 6 week period

Title

Evaluation of TAT (Thrombin-antithrombin) complex

Description

Evaluate coagulation parameters as assessed by Thrombin-anti-thrombin (TAT) on the dialyzer after blood restitution at the end of the dialytic session for sessions where sampling occurs

Time Frame

End of dialysis treatment

Title

Quality of rinse-back (filter and circuit) via a visual scale

Description

Evaluate on a qualitative photo visual score ranging from poor to very good (1-5) for the residual blood remaining in the dialyzer after rinse back at the end of the session

Time Frame

End of dialysis treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ESRD Patients aged 18 years or older Patients able to give informed consent (IC) and interested to participate in the study Stable (according to the investigator) on hemodialysis for more than 3 months with previous treatments of 3x weekly hemodialysis or hemodiafiltration Stable hemoglobin between 10 and 12 g/dl in the most recent two consecutive blood draws Stable anticoagulation and ESA regimen with no dosing modifications in the past 1 month Patients who have an adequate AVF or graft, capable of providing a blood flow rate of at least 300 mL/min according to sessions conducted in past month Exclusion Criteria: Patients who have acute renal failure with the chance for recovery. Patients who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to PD within the next two months or who require single needle dialysis therapy. Pregnant and lactating women. Patients with a history of positive serology tests for Hepatitis B surface antigen, positive Hepatitis C total antibody, HIV and syphilis. Patients with known hemodynamic instability, anemia (Hgb < 90 g/L), and/or severe bleeding risks secondary to coagulation disorders. Patients with active or ongoing infection per investigator's judgement. Patients with a history of solid tumors requiring anti-cancer therapy in the past or next 6 months or a life expectancy less than 1 year or patients with a history of a hematology neoplasm. Patients diagnosed with a NYHA Class IV congestive heart failure, or acute coronary syndrome and/or who have suffered a myocardial infarction within three months prior to the start of the study. Patients with a history of severe mental disorders. Patients who are currently participating or have previously participated in another interventional clinical trial in the past 4 weeks. Patients who have had an allergic response to polyarylethersulfone (PAES) or polysulfone membranes or have a history of poor tolerance to dialyzers with synthetic membranes. Patients with advanced liver, heart or pulmonary disease as judged by the Investigator Patients with any comorbidity possibly conflicting with the study purpose or procedures as judged by the Investigator.

Facility Information:

Facility Name

DaVita Clinical Research Germany

City

Duesseldorf

ZIP/Postal Code

D-40201

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clearum High Flux Hemodialyzer Used in Hemodialysis for Subjects With End-Stage Renal Disease

We'll reach out to this number within 24 hrs