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

NCT04087213 | Completed Results FDA Device

• 1 other identifier: DKPL-00057-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

End-Stage Renal Disease

Keywords

HemoCare™ Hemodialysis System; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

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

  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.

  31 weeks

Secondary Outcomes (4)

• The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)

  31 weeks

• The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels

  31 weeks

• The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.

  31 weeks

• Weight Change and Fluid Removed Comparison Between Evaluable Periods

  31 weeks

Study Arms (1)

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.

Device: HemoCare™ Hemodialysis System

Interventions

HemoCare™ Hemodialysis System DEVICE

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.

The HemoCare™ Hemodialysis System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Deka Research and Development: lead
• CVS Kidney Care LLC.: collaborator

Study Sites (8)

University of Mississippi Medical Center

Jackson, Mississippi, 39213, United States

Location

Dialysis Clinic, Inc - NJ

North Brunswick, New Jersey, 08902, United States

Location

The Rogosin Institute

New York, New York, 11021, United States

Location

Dialysis Clinic Inc. - Knoxville

Knoxville, Tennessee, 37924, United States

Location

Dialysis Clinic, Inc.

Nashville, Tennessee, 37203, United States

Location

Wellbound South Austin

Austin, Texas, 78744, United States

Location

Wellbound North Austin

Austin, Texas, 78758, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (6)

• 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

  BACKGROUND

• 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.

  PMID: 18160958 BACKGROUND

• 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.

  PMID: 17878421 BACKGROUND

• 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.

  PMID: 21775973 BACKGROUND

• 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.

  PMID: 19584107 BACKGROUND

• 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.

  PMID: 27190336 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Research Manager
• Organization: DEKA Research

clinical@dekaresearch.com

(603) 669-5139

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective multi-center, open-label, single-arm, cross-over study.

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 12, 2019
• Study Start: September 5, 2019
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)