CompletedNCT04087213Updated Aug 13, 2024Results posted

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

An interventional study of HemoCare™ Hemodialysis System in End-Stage Renal Disease, sponsored by Deka Research and Development. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Deka Research and Development · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 36
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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 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 studied

End-Stage Renal Disease

Browse trials for

Kidney Failure, Chronic 2,085

Keywords

HemoCare™ Hemodialysis System
Hemodialysis

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 36 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Deka Research and Development is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 36 participants (actual)

Study arms

Experimental
The HemoCare™ Hemodialysis System
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

DeviceHemoCare™ Hemodialysis System
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.

What researchers measure

Primary outcomes

Primary Safety Endpoint
Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods
Time frame: 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.
Time frame: 31 weeks

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 31 weeks

Results

Posted Aug 13, 2024

Participant flow

In-Facility Introduction

Participant flow — In-Facility Introduction
Milestone	Assisted Home Hemodialysis Then Unassisted Home Hemodialysis
Started	36
Completed	34
Not completed	2
Withdrew: Withdrawal by subject	1
Withdrew: Adverse event	1

Transition Period A

Participant flow — Transition Period A
Milestone	Assisted Home Hemodialysis Then Unassisted Home Hemodialysis
Started	34
Completed	34
Not completed	0

Assisted Evaluable Period

Participant flow — Assisted Evaluable Period
Milestone	Assisted Home Hemodialysis Then Unassisted Home Hemodialysis
Started	34
Completed	29
Not completed	5
Withdrew: Withdrawal by subject	2
Withdrew: Personal reasons	3

Transition Period B

Participant flow — Transition Period B
Milestone	Assisted Home Hemodialysis Then Unassisted Home Hemodialysis
Started	29
Completed	28
Not completed	1
Withdrew: Renal transplantation	1

Unassisted Home Evaluable Period

Participant flow — Unassisted Home Evaluable Period
Milestone	Assisted Home Hemodialysis Then Unassisted Home Hemodialysis
Started	28
Completed	28
Not completed	0

Outcome measures

PrimaryPrimary Safety Endpoint

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

Time frame:: 31 weeks
Reported as:: Number · Adverse Events per 100 Treatments

Primary Safety Endpoint
Adverse Events per 100 Treatments	Assisted Evaluable Period	Unassisted Home Evaluable Period
Primary Safety Endpoint	16.1	11.6

PrimaryPrimary 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.

Time frame:: 31 weeks
Reported as:: Number · Percentage of subjects with Kt/V ≥ 2.0

Primary Performance Endpoint
Percentage of subjects with Kt/V ≥ 2.0	Assisted Evaluable Period	Unassisted Home Evaluable Period
Primary Performance Endpoint	1 (0.92 to 1.00)	1 (0.90 to 1.00)

SecondaryThe 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.

Time frame:: 31 weeks
Reported as:: Number · events

The Total Number of AEs and SAEs (Anticipated, Unanticipated, and Device Related)
events	Assisted Evaluable Period	Unassisted Home Evaluable Period
Total Adverse Events	204	139
Anticipated Non-Serious AE	148	11
Anticipated Serious AE	5	2
Unanticipated Non-Serious AE	49	26
Unanticipated Serious AE	2	0
Device-Related Non-Serious AE	27	7
Device-Related Serious AE	0	0
Unanticipated Device-Related Non-Serious AE	0	0
Unanticipated Device-Related Serious AE	0	0

SecondaryThe 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.

Time frame:: 31 weeks
Reported as:: Number · occurrence of event

The Number of Decreased and Increased Post-dialysis Serum Phosphorus Levels
occurrence of event	Assisted Evaluable Period	Unassisted Home Evaluable Period
Decreased serum phosphorous	48	32
Increased serum phosphorous	0	2

SecondaryThe 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.

Time frame:: 31 weeks
Reported as:: Number · events

The Number of Decreased and Increased Post-dialysis Serum Potassium During Each Evaluable Period.
events	Assisted Evaluable Period	Unassisted Home Evaluable Period
Decreased serum potassium	43	24
Elevated serum potassium	0	1

SecondaryWeight 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

Time frame:: 31 weeks
Reported as:: Mean · L

Weight Change and Fluid Removed Comparison Between Evaluable Periods
L	Assisted Evaluable Period	Unassisted Home Evaluable Period
Weight Change and Fluid Removed Comparison Between Evaluable Periods	0.1 ± 3.5	0.1 ± 1.1

Adverse events

Collected over During the study period - from the time of enrollment until the end of participation in the study (31 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Assisted Evaluable Period	0/34 (0%)	5/34 (14.7%)	31/34 (91.2%)
Unassisted Home Evaluable Period	0/28 (0%)	2/28 (7.1%)	24/28 (85.7%)

Most frequent serious events

Most frequent serious events
Event	Assisted Evaluable Period	Unassisted Home Evaluable Period
Vascular access site thrombosisInjury, poisoning and procedural complications	0/34	1/28
DyspneaRespiratory, thoracic and mediastinal disorders	1/34	1/28
BacteremiaInfections and infestations	1/34	0/28
PneumoniaInfections and infestations	1/34	0/28
HypervolemiaMetabolism and nutrition disorders	1/34	0/28
AnxietyPsychiatric disorders	1/34	0/28
Acute pulmonary edemaRespiratory, thoracic and mediastinal disorders	1/34	0/28
Pleural effusionRespiratory, thoracic and mediastinal disorders	1/34	0/28

Most frequent other events

Showing 10 of 34

Most frequent other events
Event	Assisted Evaluable Period	Unassisted Home Evaluable Period
Muscle spasmsMusculoskeletal and connective tissue disorders	9/34	6/28
HeadacheNervous system disorders	8/34	6/28
HemorrhageVascular disorders	8/34	2/28
DiarrheaGastrointestinal disorders	7/34	5/28
DizzinessNervous system disorders	7/34	4/28
NauseaGastrointestinal disorders	6/34	4/28
HypophosphatemiaMetabolism and nutrition disorders	6/34	2/28
Vascular access site painInjury, poisoning and procedural complications	5/34	0/28
HypocalcemiaMetabolism and nutrition disorders	5/34	0/28
HyperphosphatemiaMetabolism and nutrition disorders	4/34	4/28

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Intent-To-Treat (ITT) Population
Mean	48.0 ± 11.2

Sex: Female, Male
Sex: Female, Male(Participants)	Intent-To-Treat (ITT) Population
Female	12
Male	22

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Intent-To-Treat (ITT) Population
Hispanic or Latino	10
Not Hispanic or Latino	24
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Intent-To-Treat (ITT) Population
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	10
White	23
More than one race	1
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Intent-To-Treat (ITT) Population
United States	34

Study locations

8 sites

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

References and documents

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 ↗

Study documents

Protocol and statistical analysis plan · Jan 21, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04087213
Lead sponsor: Deka Research and Development
Collaborators: CVS Kidney Care LLC.
Responsible party: Sponsor
First posted: Sep 12, 2019
Start date: Sep 5, 2019
Primary completion: Jan 11, 2023
Completion: Jan 11, 2023
Results posted: Aug 13, 2024
Last update: Aug 13, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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