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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

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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

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).
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  • 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.
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  • 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.

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.

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 groupRoleWhat they receive
The HemoCare™ Hemodialysis SystemExperimentalThe 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.

  1. Primary Safety Endpoint

    Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods

    Measured: 31 weeks

  2. 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)

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted12 Sep 2019
  2. Study start5 Sep 2019
  3. Primary completion11 Jan 2023
  4. Study completion11 Jan 2023

Resources

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
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

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