NCT02795286

Brief Summary

The ASIST study is a medical device study testing the safety and efficacy of a new hemodialysis machine software in chronic haemodialysis patients. The software's intention is to reduce hemodialysis related symptoms such as unwell being, blood pressure changes by adapting the dialysis fluid ion concentration to the patients plasma ion concentration by conductivity measurement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2016

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

May 17, 2016

Last Update Submit

March 11, 2025

Conditions

End Stage Renal Disease (ESRD)

Keywords

Chronic Kidney Disease (CKD)End Stage Renal Disease (ESRD)Chronic HemodialysisIn-center HDSodiumIsotonic Dialysis

Outcome Measures

Primary Outcomes (6)

  • Evaluation of Blood Pressure

    Up to 9 weeks

  • Evaluation of Heart Rate

    Up to 9 weeks

  • Occurrence of Hypotensive Episodes

    Up to 9 weeks

  • Change in Plasma Sodium

    Up to 9 weeks

  • Change in Plasma Tonicity

    Up to 9 weeks

  • Change in MCV (Erythrocyte Mean Corpuscular Volume)

    Up to 9 weeks

Study Arms (3)

ASIST A

EXPERIMENTAL

Artis Haemodialysis Machine w/ ASIST Software - Isonatremic

Device: Artis Haemodialysis Machine w/ ASIST Software - Isonatremic

ASIST B

EXPERIMENTAL

Artis Haemodialysis Machine w/ ASIST Software - Isotonic

Device: Artis Haemodialysis Machine w/ ASIST Software - Isotonic

Conventional HD

ACTIVE COMPARATOR

Artis Haemodialysis Machine w/o ASIST Software

Device: Artis Haemodialysis Machine w/o ASIST Software

Interventions

Artis Haemodialysis Machine w/ ASIST Software - IsonatremicDEVICE
ASIST A
Artis Haemodialysis Machine w/ ASIST Software - IsotonicDEVICE
ASIST B
Artis Haemodialysis Machine w/o ASIST SoftwareDEVICE
Conventional HD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be in clinically stable condition as judged by the treating physician, and demonstrated by stable medical history, physical examination, and laboratory testing for 30 days prior to enrollment.
  • Subject must be receiving HD or hemodiafiltration (HDF) for at least 30 days prior to study enrollment, be dialyzing a minimum of 3 times per week in an in-center setting and each treatment session must be between 3.5 and 5 hours in duration.
  • Subject has a stable functioning vascular access (arteriovenous \[AV\] fistula, graft, or dual-lumen tunneled catheter) based on the judgment of the treating physician and is performing dual-needle therapy with an actual blood flow rate of 250 - 400 mL/min.
  • Subject has a pre-dialysis plasma sodium of ≥132 mmol/L for at least 60 days prior to study enrollment.
  • Subject has achieved a dialysis dose of stdKt/Vurea ≥ 2.1 within 60 days prior to enrollment.
  • Subject has a pre-dialysis hemoglobin ≥ 90 g/L measured at Screening.

You may not qualify if:

  • Female subjects who are pregnant, lactating, or planning to become pregnant during the study period.
  • Subjects who have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide Informed Consent and/or comply with protocol procedures.
  • Subjects with a medical condition that the investigator thinks may interfere with the study objectives.
  • Subjects with significant signs of access recirculation as judged by the treating physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skane University Hospital

Malmo, Skåne County, 205 02, Sweden

Location

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2016

First Posted

June 10, 2016

Study Start

March 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)