End-Stage Renal DiseaseNCT04087213

Study of HemoCare™ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD

A study testing HemoCare™ Hemodialysis System in people with End-Stage Renal Disease, run by Deka Research and Development at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This prospective multi-center, open-label, single-arm study intends to gather and evaluate safety data for the nocturnal use of the HemoCare™ Hemodialysis System. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End-Stage Renal Disease
What is being tested?: HemoCare™ Hemodialysis System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 8 sitesUnited States
Study dates: 5 Sep 2019to 11 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have been diagnosed with ESRD and are ≥ 18 years of age.
Are in stable clinical condition as judged by the treating physician, and confirmed by medical history, physical exam, and laboratory testing for 30 days prior to enrollment.
Have been receiving HD for at least 30 days prior to study enrollment, are expected to survive for at least 12 months and in the opinion of the Investigator are stable to start in the trial.
Have been dialyzing in a supervised medical facility or at home for ≥ 3 times per week.
Are willing to comply with the study requirements for training and therapy with HemoCare™ Hemodialysis System for the entire study treatment period.
Understand English and can provide written informed consent (both the subject and care partner).

Show all 9Show fewer

Are judged by the Investigator to be suitable for Home HD (the Investigator deems that with appropriate training, the subject and/or care partner will be able to successfully cannulate and/or manage the vascular access during the Unassisted Home Evaluable Period).
Have a stable functioning vascular access as judged by the treating physician.
Have a weekly stdKt/Vurea ≥ 2.0, an equivalent URR ≥ 0.65, rated Kt/Vurea ≥ 1.0 on one occasion within 30 days prior to enrollment.

Who cannot join

Are pre-scheduled for a living donor transplant within the next 6 months.
Have a contraindication to heparin.
Are currently participating in another interventional study.
Have experienced an acute myocardial infarction with hospitalization, coronary artery bypass surgery, or acute coronary ischemia requiring angioplasty or stent insertion within 90 days of screening.
Have ongoing NYHA Class III or IV heart failure.
Have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide informed consent and/or comply with study procedures.

Show all 10Show fewer

Have ongoing sepsis or bacteremia and currently require IV antibiotics.
Have an allergy to polysulfone dialyzer.
Current self-reported pregnancy, actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study.
Subject with fluid overload due to intractable ascites secondary to liver cirrhosis

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Wellbound South Austin
Austin, Texas, 78744
Wellbound North Austin
Austin, Texas, 78758
University of Virginia
Charlottesville, Virginia, 22908
University of Mississippi Medical Center
Jackson, Mississippi, 39213
Dialysis Clinic Inc. - Knoxville
Knoxville, Tennessee, 37924
Dialysis Clinic, Inc.
Nashville, Tennessee, 37203
The Rogosin Institute
New York, New York, 11021
Dialysis Clinic, Inc - NJ
North Brunswick, New Jersey, 08902

Other trials in United States

About this study

Official title: Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis

This prospective multi-center, open-label, single-arm study intends to gather and evaluate safety data for the nocturnal use of the HemoCare™ Hemodialysis System.

Read the detailed description

The HemoCare™ Hemodialysis System has been evaluated in previous clinical trials and is designed to perform hemodialysis (HD) in a clinic setting, in a self-care setting, or in a home environment for conventional HD, short daily HD or extended-duration HD therapy during the daytime or at night dependent on the users' lifestyle or work schedule. This multi-center, open-label, single-arm cross-over study is designed specifically to gather and evaluate safety data for the use of the HemoCare™ Hemodialysis System (including labeling and training tools) during home nocturnal (during sleeping hours based on the patient schedule) use. Nocturnal HD therapy was chosen as a treatment in this study because of the clinical and humanistic benefits associated with it. In addition, its risk profile, especially when performed in a home setting, may be greater than either existing conventional or short daily HD therapies. In this regard, establishing an acceptable safety profile for home nocturnal HD therapy should be sufficient evidence to support conventional and short daily HD home therapies with HemoCare™ Hemodialysis System.

Conditions: End-Stage Renal Disease
Being tested: HemoCare™ Hemodialysis System
Keywords: HemoCare™ Hemodialysis System, Hemodialysis
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HemoCare™ Hemodialysis SystemDevice
The HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.

Study groups in NCT04087213
Study group	Role	What they receive
The HemoCare™ Hemodialysis System	Experimental	The HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician. Receives: Device: HemoCare™ Hemodialysis System

What is being measured

The primary outcome is the main question the study is designed to answer.

Primary Safety Endpoint
Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods
Measured: 31 weeks
Primary Performance Endpoint
Weekly stdKt/Urea was calculated from pre- and post-dialysis urea levels during each evaluable period. Blood samples were obtained every two weeks during each Evaluable Period. For the primary performance endpoint, 'success' is defined as a subject who has all stdKt/Vurea measures in an evaluable period greater than or equal to 2.0.
Measured: 31 weeks

Secondary outcomes (4)

The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Number of anticipated and unanticipated AEs and SAEs during each Evaluable Period including number of device-related AEs and SAEs.
Measured: 31 weeks
The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels
The number of decreased serum phosphorus defined as at least 1 post-dialysis serum phosphorus level < 2.2 mg/dL , the number of elevated serum phosphorous defined as a least 1 post-dialysis serum phosphorus level > 5.5 mg/dL, will each be compared between Evaluable Periods with exact McNemar's tests.
Measured: 31 weeks
The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.
The number of decreased serum potassium defined as at least 1 post-dialysis serum potassium level of < 3.5 meq/L , and the number of elevated serum potassium defined as at least 1 post-dialysis serum potassium level of > 5.9 meq/L, will each be compared between Evaluable Periods with exact McNemar's tests.
Measured: 31 weeks
Weight Change and Fluid Removed Comparison Between Evaluable Periods
HemoCare Ultrafiltration Comparison by Evaluable Period was determined by the following:
Discrepancy between Weight Change and Net UF removed = Weight change - Net UF Removed
Weight change = Ending weight - Starting weight (measured by digital weight scale).
Net Ultrafiltration Removed = total UF removed - prime \& rinseback, reported by the HemoCare system.
Note: One kilogram (kg) = one liter (L) of fluid
Measured: 31 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 201911 Jan 2023

First posted12 Sep 2019
Study start5 Sep 2019
Primary completion11 Jan 2023
Study completion11 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for End-Stage Renal DiseaseStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: This is a prospective multi-center, open-label, single-arm, cross-over study.
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04087213
Sponsor's protocol ID: DKPL-00057-001
Status last verified: Jan 2024
First submitted: 30 Aug 2019
Last updated: 13 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

U.S. Renal Data System. USRDS 2017 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2017
Eloot S, Van Biesen W, Dhondt A, Van de Wynkele H, Glorieux G, Verdonck P, Vanholder R. Impact of hemodialysis duration on the removal of uremic retention solutes. Kidney Int. 2008 Mar;73(6):765-70. doi: 10.1038/sj.ki.5002750. Epub 2007 Dec 26.
PubMed 18160958
Culleton BF, Walsh M, Klarenbach SW, Mortis G, Scott-Douglas N, Quinn RR, Tonelli M, Donnelly S, Friedrich MG, Kumar A, Mahallati H, Hemmelgarn BR, Manns BJ. Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life: a randomized controlled trial. JAMA. 2007 Sep 19;298(11):1291-9. doi: 10.1001/jama.298.11.1291.
PubMed 17878421
Rocco MV, Lockridge RS Jr, Beck GJ, Eggers PW, Gassman JJ, Greene T, Larive B, Chan CT, Chertow GM, Copland M, Hoy CD, Lindsay RM, Levin NW, Ornt DB, Pierratos A, Pipkin MF, Rajagopalan S, Stokes JB, Unruh ML, Star RA, Kliger AS; Frequent Hemodialysis Network (FHN) Trial Group; Kliger A, Eggers P, Briggs J, Hostetter T, Narva A, Star R, Augustine B, Mohr P, Beck G, Fu Z, Gassman J, Greene T, Daugirdas J, Hunsicker L, Larive B, Li M, Mackrell J, Wiggins K, Sherer S, Weiss B, Rajagopalan S, Sanz J, Dellagrottaglie S, Kariisa M, Tran T, West J, Unruh M, Keene R, Schlarb J, Chan C, McGrath-Chong M, Frome R, Higgins H, Ke S, Mandaci O, Owens C, Snell C, Eknoyan G, Appel L, Cheung A, Derse A, Kramer C, Geller N, Grimm R, Henderson L, Prichard S, Roecker E, Rocco M, Miller B, Riley J, Schuessler R, Lockridge R, Pipkin M, Peterson C, Hoy C, Fensterer A, Steigerwald D, Stokes J, Somers D, Hilkin A, Lilli K, Wallace W, Franzwa B, Waterman E, Chan C, McGrath-Chong M, Copland M, Levin A, Sioson L, Cabezon E, Kwan S, Roger D, Lindsay R, Suri R, Champagne J, Bullas R, Garg A, Mazzorato A, Spanner E, Rocco M, Burkart J, Moossavi S, Mauck V, Kaufman T, Pierratos A, Chan W, Regozo K, Kwok S. The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial. Kidney Int. 2011 Nov;80(10):1080-91. doi: 10.1038/ki.2011.213. Epub 2011 Jul 20.
PubMed 21775973
Pauly RP, Gill JS, Rose CL, Asad RA, Chery A, Pierratos A, Chan CT. Survival among nocturnal home haemodialysis patients compared to kidney transplant recipients. Nephrol Dial Transplant. 2009 Sep;24(9):2915-9. doi: 10.1093/ndt/gfp295. Epub 2009 Jul 7.
PubMed 19584107
Bernardo AA, Marbury TC, McFarlane PA, Pauly RP, Amdahl M, Demers J, Hutchcraft AM, Leypoldt JK, Minkus M, Muller M, Stallard R, Culleton BF. Clinical safety and performance of VIVIA: a novel home hemodialysis system. Nephrol Dial Transplant. 2017 Apr 1;32(4):685-692. doi: 10.1093/ndt/gfw044.
PubMed 27190336

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End-Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis
ClinicalTrials.gov ID: NCT04087213
Acronym / sponsor ID: DKPL-00057-001
Conditions: End-Stage Renal Disease
Keywords: HemoCare™ Hemodialysis System, Hemodialysis
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Deka Research and DevelopmentIndustry (pharma, biotech, devices)
Collaborators: CVS Kidney Care LLC.
Study start: 5 Sep 2019 (actual)
Primary completion: 11 Jan 2023 (actual)
Study completion: 11 Jan 2023 (actual)
First posted: 12 Sep 2019 (actual)
Results: Posted 13 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This prospective multi-center, open-label, single-arm study intends to gather and evaluate safety data for the nocturnal use of the HemoCare™ Hemodialysis System.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a prospective multi-center, open-label, single-arm, cross-over study.

Arm	Type	Receives
The HemoCare™ Hemodialysis System	Experimental	Device: HemoCare™ Hemodialysis SystemThe HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Have been diagnosed with ESRD and are ≥ 18 years of age.
Are in stable clinical condition as judged by the treating physician, and confirmed by medical history, physical exam, and laboratory testing for 30 days prior to enrollment.
Have been receiving HD for at least 30 days prior to study enrollment, are expected to survive for at least 12 months and in the opinion of the Investigator are stable to start in the trial.
Have been dialyzing in a supervised medical facility or at home for ≥ 3 times per week.
Are willing to comply with the study requirements for training and therapy with HemoCare™ Hemodialysis System for the entire study treatment period.

Key exclusion criteria (10 listed)

Are pre-scheduled for a living donor transplant within the next 6 months.
Have a contraindication to heparin.
Are currently participating in another interventional study.
Have experienced an acute myocardial infarction with hospitalization, coronary artery bypass surgery, or acute coronary ischemia requiring angioplasty or stent insertion within 90 days of screening.
Have ongoing NYHA Class III or IV heart failure.

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
HemoCare™ Hemodialysis SystemThe HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.	Device	The HemoCare™ Hemodialysis System

Primary outcome

Primary Safety Endpoint
Time frame: 31 weeks
Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods
Primary Performance Endpoint
Time frame: 31 weeks
Weekly stdKt/Urea was calculated from pre- and post-dialysis urea levels during each evaluable period. Blood samples were obtained every two weeks during each Evaluable Period. For the primary performance endpoint, 'success' is defined as a subject who has all stdKt/Vurea measures in an evaluable period greater than or equal to 2.0.

4 secondary outcomes

The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
Time frame: 31 weeks
The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels
Time frame: 31 weeks
The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.
Time frame: 31 weeks
Weight Change and Fluid Removed Comparison Between Evaluable Periods
Time frame: 31 weeks

Results and safety

Results posted to the registry on 13 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Assisted Home Hemodialysis Then Unassisted Home Hemodialysis	36	34

Primary outcome: Primary Safety Endpoint

Time frame: 31 weeks. Number. Unit: Adverse Events per 100 Treatments

Measure	Assisted Evaluable Period n = 34	Unassisted Home Evaluable Period n = 28
Value	16.1	11.6

Population analysed: The ITT population was defined as all subjects who used HemoCare Hemodialysis System at least once during the Assisted Evaluable Period.

Primary outcome: Primary Performance Endpoint

Time frame: 31 weeks. Number (90% Confidence Interval). Unit: Percentage of subjects with Kt/V ≥ 2.0

Measure	Assisted Evaluable Period n = 34	Unassisted Home Evaluable Period n = 28
Value	1 (0.92 to 1.00)	1 (0.90 to 1.00)

Population analysed: Weekly stdKt/Vurea collected from the Intent-To-Treat (ITT) Population

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the study period - from the time of enrollment until the end of participation in the study (31 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Assisted Evaluable Period	5 of 34 (14.7%)	31 of 34 (91.2%)	0 of 34
Unassisted Home Evaluable Period	2 of 28 (7.1%)	24 of 28 (85.7%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundU.S. Renal Data System. USRDS 2017 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2017
Background: PubMed 18160958Eloot S, Van Biesen W, Dhondt A, Van de Wynkele H, Glorieux G, Verdonck P, Vanholder R. Impact of hemodialysis duration on the removal of uremic retention solutes. Kidney Int. 2008 Mar;73(6):765-70. doi: 10.1038/sj.ki.5002750. Epub 2007 Dec 26.
Background: PubMed 17878421Culleton BF, Walsh M, Klarenbach SW, Mortis G, Scott-Douglas N, Quinn RR, Tonelli M, Donnelly S, Friedrich MG, Kumar A, Mahallati H, Hemmelgarn BR, Manns BJ. Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life: a randomized controlled trial. JAMA. 2007 Sep 19;298(11):1291-9. doi: 10.1001/jama.298.11.1291.
Background: PubMed 21775973Rocco MV, Lockridge RS Jr, Beck GJ, Eggers PW, Gassman JJ, Greene T, Larive B, Chan CT, Chertow GM, Copland M, Hoy CD, Lindsay RM, Levin NW, Ornt DB, Pierratos A, Pipkin MF, Rajagopalan S, Stokes JB, Unruh ML, Star RA, Kliger AS; Frequent Hemodialysis Network (FHN) Trial Group; Kliger A, Eggers P, Briggs J, Hostetter T, Narva A, Star R, Augustine B, Mohr P, Beck G, Fu Z, Gassman J, Greene T, Daugirdas J, Hunsicker L, Larive B, Li M, Mackrell J, Wiggins K, Sherer S, Weiss B, Rajagopalan S, Sanz J, Dellagrottaglie S, Kariisa M, Tran T, West J, Unruh M, Keene R, Schlarb J, Chan C, McGrath-Chong M, Frome R, Higgins H, Ke S, Mandaci O, Owens C, Snell C, Eknoyan G, Appel L, Cheung A, Derse A, Kramer C, Geller N, Grimm R, Henderson L, Prichard S, Roecker E, Rocco M, Miller B, Riley J, Schuessler R, Lockridge R, Pipkin M, Peterson C, Hoy C, Fensterer A, Steigerwald D, Stokes J, Somers D, Hilkin A, Lilli K, Wallace W, Franzwa B, Waterman E, Chan C, McGrath-Chong M, Copland M, Levin A, Sioson L, Cabezon E, Kwan S, Roger D, Lindsay R, Suri R, Champagne J, Bullas R, Garg A, Mazzorato A, Spanner E, Rocco M, Burkart J, Moossavi S, Mauck V, Kaufman T, Pierratos A, Chan W, Regozo K, Kwok S. The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial. Kidney Int. 2011 Nov;80(10):1080-91. doi: 10.1038/ki.2011.213. Epub 2011 Jul 20.
Background: PubMed 19584107Pauly RP, Gill JS, Rose CL, Asad RA, Chery A, Pierratos A, Chan CT. Survival among nocturnal home haemodialysis patients compared to kidney transplant recipients. Nephrol Dial Transplant. 2009 Sep;24(9):2915-9. doi: 10.1093/ndt/gfp295. Epub 2009 Jul 7.
Background: PubMed 27190336Bernardo AA, Marbury TC, McFarlane PA, Pauly RP, Amdahl M, Demers J, Hutchcraft AM, Leypoldt JK, Minkus M, Muller M, Stallard R, Culleton BF. Clinical safety and performance of VIVIA: a novel home hemodialysis system. Nephrol Dial Transplant. 2017 Apr 1;32(4):685-692. doi: 10.1093/ndt/gfw044.
Individual participant dataSharing planned: No

Related trials for End-Stage Renal Disease

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Not yet recruiting
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Recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HemoCare™ Hemodialysis System in people with End-Stage Renal Disease, run by Deka Research and Development at 8 sites in United States.

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 9 inclusion and 10 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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Primary Safety Endpoint (time frame: 31 weeks). The study lists 2 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 NCT04087213, which also lists 6 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 13 Aug 2024.