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

End-Stage Renal Disease Clinical Trial

Official title:

Clinical Evaluation of the HemoCare™ Hemodialysis System for Home Nocturnal Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087213
• Other study ID #: DKPL-00057-001
• Status: Completed
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: January 11, 2023

Study information

• Verified date: February 2023
• Source: Deka Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 11, 2023
• Est. primary completion date: January 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Wellbound North Austin	Austin	Texas
United States	Wellbound South Austin	Austin	Texas
United States	University of Virginia	Charlottesville	Virginia
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Dialysis Clinic Inc. - Knoxville	Knoxville	Tennessee
United States	Dialysis Clinic, Inc.	Nashville	Tennessee
United States	The Rogosin Institute	New York	New York
United States	Dialysis Clinic, Inc - NJ	North Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Deka Research and Development	CVS Kidney Care LLC.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The reliability and the ability of the HemoCareTM Hemodialysis System	To assess the reliability and ability of the HemoCareTM Hemodialysis System to deliver the prescribed treatments. Treatments will be classified as either complete (receiving at least 90% of planned treatment time), incomplete (receiving less than this), or missed altogether by the site staff. Planned treatment will be defined as the treatment time selected and confirmed by the user at the start of each treatment.	31 weeks
Other	Descriptive summary statistics of successful and unsuccessful completion of subjects completing HemoCareTM training and entering Unassisted Home Evaluation Period	Descriptive summary statistics of the proportion of subjects and care partners who successfully complete training with HemoCareTM and enter the Unassisted Home Evaluation Period of the study.	31 weeks
Other	Renal Treatment Satisfaction Questionnaire (RTSQ)	RTSQ is an established Questionnaire to assess the treatment of the subject's kidney condition and their experience over the weeks prior to week 6.	31 weeks
Other	Patient Recovery Time Questionnaire	PRTQ is an established Questionnaire to determine how many minutes the subject takes to recover from a dialysis session.	31 weeks
Other	Zarit Burden Interview - 12 item version (ZBI-12)	ZBI-12 is an established Questionnaire to determine care partner scores measuring the act of taking care of another person	31 weeks
Other	Descriptive summary of the time(s) to resolve HemoCareTM device alarms	During the dialysis session, a summary of the time(s) to resolve the alarms will be measured.	31 weeks
Primary	Primary Safety Endpoint	Adverse event (AE) rate per 100 HemoCare™ Hemodialysis System treatments during Assisted and Unassisted Home Evaluable Periods	31 weeks
Primary	Primary Performance Endpoint	Weekly stdKt/Vurea as measured every two weeks during each Evaluable Period.	31 weeks
Secondary	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.	31 weeks
Secondary	The incidences of decreased and increased post-dialysis serum phosphorus levels	The incidence of decreased serum phosphorus defined as at least 1 post-dialysis serum phosphorus level < 2.2 mg/dL , the incidence 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.	31 weeks
Secondary	The incidences of decreased and increased post-dialysis serum potassium during each Evaluable Period.	The incidence of decreased serum potassium defined as at least 1 post-dialysis serum potassium level of < 3.5 meq/L , and the incidence 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.	31 weeks
Secondary	A descriptive summary of ultrafiltration and target weight during each Evaluable Period.	A descriptive summary of ultrafiltration and target pre-dialysis and post-dialysis weight during each Evaluable Period.	31 weeks