N/A
N=10
Study to Compare Safety and Tolerability of AKST1210 Column at 2 Blood Flow Rates in Subjects With ESRD on Hemodialysis
End-Stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT04985383 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Safety as Evaluated by Rate and Severity of Treatment-emergent AEs (TEAEs) — 1; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- AKST1210 S-15 at 250 mL/min (Device); AKST1210 S-15 at 450 mL/min (Device); AKST1210 S-25 at 250 mL/min (Device); AKST1210 S-25 at 450 mL/min (Device); AKST1210 S-35 at 250 mL/min (Device); AKST1210 S-35 at 450 mL/min (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Alkahest, Inc.
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety as Evaluated by Rate and Severity of Treatment-emergent AEs (TEAEs) |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Safety as Evaluated by the Number of Subjects With Intradialytic Hypotensive (IDH) Events |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Safety as Evaluated by Changes in Total Hemoglobin (Hgb) |
4.9; 2.2; -4.3; -7.1 | — |
| PRIMARY Safety as Evaluated by Changes in Free Hemoglobin (Hgb) |
3.4; 1.5; 49.0; 8.7 | — |
| SECONDARY Adequacy of Hemodialysis Measured With Kt/V |
1.3; 1.8; 1.2; 1.6; 1.4; 1.6 | — |
| SECONDARY Adequacy of Hemodialysis Measured by Urea Reduction Ratio (URR) |
66.2; 77.1; 55.0; 74.1; 68.2; 75.0 | — |
| SECONDARY Total Fluid Balance for Each Column-Size Blood-Flow Rate Combination |
2144.4; 2288.9; 1933.3; 2344.4; 2100.0; 2566.7 | — |
| SECONDARY Number of Participants Who Achieved the Dry Weight Goal |
4; 4; 2; 5; 5; 4 | — |
| SECONDARY Plasma Beta-2 Microglobulin (b2M) Concentrations (Before and After HD) and Contribution of the AKST1210 Column to b2M Removal at Each Column Size and Blood-flow Rate |
-0.9; -1.0; -0.8; -1.1; -0.9; -1.3 | — |
| SECONDARY Number of Occurrences of Visible Thrombosis (Clotting) in the AKST1210 Column, Dialyzer, and/or Tubing |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Plasma Levels of Complement Factors, Including Total Complement CH50, Soluble Complement SC5b-9, and Complement C5a |
67.4; 63.6; 61.5; 296.7; 624.2; 896.7 | — |
| SECONDARY Plasma Levels of Other Proteins, Including Insulin and Adrenocorticotropic Hormone (ACTH) |
87.7; 64.4; 35.2; 11.1; 8.9; 8.7 | — |
| SECONDARY Plasma Levels of Other Proteins, Including Insulin-Like Growth Factor Binding Prot1 (IGFBP1) |
86.5; 92.6; 114.7 | — |
Summary
This study is to evaluate the safety and tolerability of the AKST1210 column at blood-flow rates greater than 250 mL/min in subjects with end-stage renal disease (ESRD) undergoing hemodialysis (HD). The study will assess the safety, tolerability, and impact on HD parameters when the AKST1210 column is used at a blood-flow of up to 450 mL/min.
Eligibility Criteria
Inclusion Criteria
- Males and females aged 40 - 75 years, inclusive.
- End Stage Renal Disease (ESRD) requiring HD.
- Dialysis vintage ≥ 24 months.
- Absence of clinically-relevant residual renal function.
- Regular Hemodialysis (HD) sessions done at blood-flow rates between 400 and 500 mL/min, and with inter-dialysis intervals of 48 hours or more.
- Stable health status for at least 4 weeks prior to screening based on medical history, and findings from physical examination, laboratory tests, vital signs, and ECG, as assessed by the investigator.
- Life expectancy > 6 months (as determined by the investigator).
- Body mass index (BMI) between 18 and 37 kg/m2, inclusive, with a minimum body weight of 52 kg.
- Must be on stable doses (> 4 weeks) of all treatments for concomitant diseases (e.g., diabetes, hypertension), but this does not apply to medications for conditions related to ESRD (e.g., medications for calcium and phosphate control, anemia).
- Must be able to follow the study protocol and receive the treatment in the established timeframe.
- Must provide a signed and dated informed consent form.
Exclusion Criteria
- Patients for whom adequate anticoagulation cannot be achieved, such as those with severe anemia, severe hemorrhagic diathesis, severe gastrointestinal ulcers, or who are receiving anticoagulant medications for any reason other than as required for HD. Use of antiplatelet drugs (e.g., aspirin or clopidogrel) is allowed.
- Patients for whom extracorporeal circulation therapy is contraindicated, such as those with severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute seizure disorder, or severe uncontrolled hypertension.
- Patients with Kt/V 3 times upper limit of normal.
- Uncontrolled type 2 diabetes.
- Concurrent or have recent participation in another interventional clinical trial. Prior clinical trial subjects must have discontinued investigational agents/devices at least 30 days prior to planned first use of the AKST1210 column.
- History of severe depression/suicidality requiring hospitalization in the last 6 months.
- Significant drug or alcohol abuse within the past 12 months.
- Patients planning to receive renal transplantation during the study.
- Patients with any other condition and/or situation the investigator believes may interfere with the safety of the subject during study participation, study conduct, or interpretation of study data.
Data sourced from ClinicalTrials.gov (NCT04985383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.