Renal FailurePhase 1WAKNCT00454974
Pilot Study of Wearable Artificial Kidney
A Phase 1 study testing Wearable artificial kidney in people with Renal Failure, run by Royal Free Hampstead NHS Trust at 1 site in United Kingdom.
Trial summary
This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- Wearable artificial kidney
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2007to Mar 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- End stage renal failure
- Regular haemodialysis
- Cardiovascular stability
- Stable vascular access
Who cannot join
- Allergy to heparin or ethylene oxide
- Recent cardiovascular or neurological event
- Unable to provide informed consent
- Age < 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Study to Assess the Safety and Efficacy of a Wearable Artificial Kidney Device for the Treatment of Patients With Endstage Renal Failure
This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.
Read the detailed description
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
- Renal Failure
- Being tested
- Wearable artificial kidney
- Keywords
- end stage renal failure, dialysis, wearable artificial kidney
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable artificial kidneyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
urea, potassium, phosphate and B2M clearances
safety - cardiovascular,no hemolysis, bleeding, infection
no ammonia generation from sorbents, control of acid base balance
Secondary outcomes (3)
fluid removal
patient satisfaction questionnaire
affect of treatment of cytokines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2007 (estimated)
- Study startMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants
Sponsor and investigators
- Lead sponsor
- Royal Free Hampstead NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Xcorporeal
- Investigators
- Victor Gurra, MD, Principal investigator, Cedars Sinai, Los Angeles, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454974
- Sponsor's protocol ID
- RD7465
- Other IDs
- R&D Number 7465
- Acronym
- WAK
- Status last verified
- Mar 2007
- First submitted
- 29 Mar 2007
- Last updated
- 2 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15876856Gura 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.
PubMed 19376616
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study to Assess the Safety and Efficacy of a Wearable Artificial Kidney Device for the Treatment of Patients With Endstage Renal Failure
- ClinicalTrials.gov ID
- NCT00454974
- Acronym / sponsor ID
- WAK / RD7465
- Conditions
- Renal Failure
- Keywords
- end stage renal failure, dialysis, wearable artificial kidney
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants
- Lead sponsor
- Royal Free Hampstead NHS TrustUniversity, hospital or other
- Collaborators
- Xcorporeal
- Study start
- Mar 2007
- Study completion
- Mar 2007 (actual)
- First posted
- 2 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- End stage renal failure
- Regular haemodialysis
- Cardiovascular stability
- Stable vascular access
Key exclusion criteria (4 listed)
- Allergy to heparin or ethylene oxide
- Recent cardiovascular or neurological event
- Unable to provide informed consent
- Age < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable artificial kidney | Device | – |
Primary outcome
urea, potassium, phosphate and B2M clearances
safety - cardiovascular,no hemolysis, bleeding, infection
no ammonia generation from sorbents, control of acid base balance
3 secondary outcomes
fluid removal
patient satisfaction questionnaire
affect of treatment of cytokines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2007.
- Background: PubMed 15876856Gura 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.
- Derived from this study: PubMed 19376616Gura 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Gurra, MD principal investigator
Cedars Sinai, Los Angeles, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Wearable artificial kidney in people with Renal Failure, run by Royal Free Hampstead NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urea, potassium, phosphate and B2M clearances. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00454974, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2007.