Pilot Study of Wearable Artificial Kidney

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a pilot study to evaluate the clearances, tolerability and safety of a wearable artificial kidney device for treating patients with chronic kidney failure.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wearable artificial kidney

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* End stage renal failure
* Regular haemodialysis
* Cardiovascular stability
* Stable vascular access

Exclusion Criteria

* Allergy to heparin or ethylene oxide
* Recent cardiovascular or neurological event
* Unable to provide informed consent
* Age \< 18

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Victor Gurra, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars Sinai, Los Angeles, USA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UCL Center for Nephrology

London, London, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Gura V, Beizai M, Ezon C, Polaschegg HD. Continuous renal replacement therapy for end-stage renal disease. The wearable artificial kidney (WAK). Contrib Nephrol. 2005;149:325-333. doi: 10.1159/000085694.

Reference Type BACKGROUND

PMID: 15876856 (View on PubMed)

Gura V, Davenport A, Beizai M, Ezon C, Ronco C. Beta2-microglobulin and phosphate clearances using a wearable artificial kidney: a pilot study. Am J Kidney Dis. 2009 Jul;54(1):104-11. doi: 10.1053/j.ajkd.2009.02.006. Epub 2009 Apr 19.

Reference Type DERIVED

PMID: 19376616 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R&D Number 7465

Identifier Type: -

Identifier Source: secondary_id

RD7465