Frequent Hemodialysis Network: Nocturnal Trial

NCT00271999 | Unknown Phase 2 DMC

• 2 other identifiers: beck-night5U01DK066597
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The Frequent Hemodialysis (FHN) Nocturnal Trial is a randomized controlled trial recruiting subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 12 months. Subjects will be randomized to conventional hemodialysis delivered three days per week home arm or to the six times per week nocturnal home hemodialysis arm which will follow any dialysis prescription provided their prescribed standardized Kt/V is at least 4.0 and treatment time is at least 6.0 hours, six times per week.

Conditions

End Stage Renal Disease; Hemodialysis

Keywords

randomized controlled clinical trial; hemodialysis; End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• composite of 12 month mortality and the change over 12 months in left ventricular mass by cine-MRI,

  12 months

• a composite of 12 month mortality and the change over 12 months in the SF-36 RAND physical health composite

  12 months

Secondary Outcomes (4)

• cardiovascular structure/funct (change in LV mass over 12 mos), health-related QoL/phys funct (change over 12 mos in PHC),

  12 months

• depression/dis burden (change over 12 mos in Beck Depression Inv.),nutrition (change over 12 mos in serum albumin, cognitive funct (change over 12 mos in TrailMaking Test B),mineral metabolism (change over 12 mos in aveg pre-dialysis serum phosphorus),

  12 months

• clin events (rate of non-access hospital or death

  12 months

• hypertension,anemia

  12 months

Study Arms (2)

1

ACTIVE COMPARATOR

Three times a week conventional at home hemodialysis

Behavioral: Nocturnal home hemodialysis

2

EXPERIMENTAL

Six times a week nocturnal home hemodialysis

Behavioral: Nocturnal home hemodialysis

Interventions

Nocturnal home hemodialysis BEHAVIORAL

Six times per week nocturnal home hemodialysis

1; 2

Eligibility Criteria

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

You may qualify if:

• Patients with end stage renal disease requiring chronic renal replacement therapy
• Age ≥ 18 years,
• Achieved mean eKt/V of ≥ 1.1 during Baseline

You may not qualify if:

• GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
• Expectation that native kidneys will recover kidney function
• Current access is temporary non-tunneled catheter
• Unable to follow the nocturnal home hemodialysis training protocol for any reason, including inability to train the patient or the patient's caregiver
• Non-compliance with hemodialysis or peritoneal dialysis treatments in the past
• Medical conditions that would prevent the patient from performing the cardiac MRI procedure (e.g., inability to remain still for the procedure, a metallic object in the body, including cardiac pacemaker, inner ear (cochlear) implant, brain aneurysm clips, mechanical heart valves, recently placed artificial joints, and older vascular stents)
• Unable to verbally communicate in English or Spanish
• Currently on daily or nocturnal HD, or less than 3 months since the patient discontinued daily or nocturnal HD
• Scheduled for living donor kidney transplant, change to peritoneal dialysis, or plans to relocate to an area outside of the referral area of one of the Clinical Centers within the next 12 months
• Expected geographic unavailability at the Clinical Center (for standard arm patients) or at home (for nocturnal arm patients) for \> 2 consecutive weeks or \> 5 weeks total during the next 12 months (excluding unavailability due to hospitalizations)
• Less than 3 months since the patient returned after acute rejection resulting in allograft failure
• Currently in acute care or chronic care hospital
• Life expectancy less than six months
• A medical history that might limit the individual's ability to take trial treatments for the 12 month duration of the study, including: currently receiving chemo or radiotherapy for a malignant neoplastic disease other than localized non-melanoma skin cancer, active systemic infection (including tuberculosis, disseminated fungal infection, active AIDS but not HIV), and cirrhosis with encephalopathy
• Current pregnancy or planning to become pregnant within the next fourteen months (patients require a higher dose of dialysis if pregnant). All female patients that have not gone through menopause will need to use an effective contraceptive method while enrolled in the study.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Wake Forest University - Core center plus other centers in U.S. and Canada

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (14)

• Suri RS, Garg AX, Chertow GM, Levin NW, Rocco MV, Greene T, Beck GJ, Gassman JJ, Eggers PW, Star RA, Ornt DB, Kliger AS; Frequent Hemodialysis Network Trial Group. Frequent Hemodialysis Network (FHN) randomized trials: study design. Kidney Int. 2007 Feb;71(4):349-59. doi: 10.1038/sj.ki.5002032. Epub 2006 Dec 13.

  PMID: 17164834 BACKGROUND

• Kliger AS; Frequent Hemodialysis Network Study Group. High-frequency hemodialysis: rationale for randomized clinical trials. Clin J Am Soc Nephrol. 2007 Mar;2(2):390-2. doi: 10.2215/CJN.03110906. Epub 2006 Dec 20. No abstract available.

  PMID: 17699439 BACKGROUND

• Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

  PMID: 37651553 DERIVED

• Chan CT, Kaysen GA, Beck GJ, Li M, Lo JC, Rocco MV, Kliger AS; FHN Trials. The effect of frequent hemodialysis on matrix metalloproteinases, their tissue inhibitors, and FGF23: Implications for blood pressure and left ventricular mass modification in the Frequent Hemodialysis Network trials. Hemodial Int. 2020 Apr;24(2):162-174. doi: 10.1111/hdi.12807. Epub 2019 Dec 11.

  PMID: 31826326 DERIVED

• Chan CT, Kaysen GA, Beck GJ, Li M, Lo J, Rocco MV, Kliger AS; FHN Trials. Changes in Biomarker Profile and Left Ventricular Hypertrophy Regression: Results from the Frequent Hemodialysis Network Trials. Am J Nephrol. 2018;47(3):208-217. doi: 10.1159/000488003. Epub 2018 Apr 5.

  PMID: 29621747 DERIVED

• Lo JC, Beck GJ, Kaysen GA, Chan CT, Kliger AS, Rocco MV, Li M, Chertow GM; FHN Study. Thyroid function in end stage renal disease and effects of frequent hemodialysis. Hemodial Int. 2017 Oct;21(4):534-541. doi: 10.1111/hdi.12527. Epub 2017 Mar 16.

  PMID: 28301073 DERIVED

• Garg AX, Suri RS, Eggers P, Finkelstein FO, Greene T, Kimmel PL, Kliger AS, Larive B, Lindsay RM, Pierratos A, Unruh M, Chertow GM; Frequent Hemodialysis Network Trial Investigators. Patients receiving frequent hemodialysis have better health-related quality of life compared to patients receiving conventional hemodialysis. Kidney Int. 2017 Mar;91(3):746-754. doi: 10.1016/j.kint.2016.10.033. Epub 2017 Jan 13.

  PMID: 28094031 DERIVED

• Lo JC, Beck GJ, Kaysen GA, Chan CT, Kliger AS, Rocco MV, Chertow GM; FHN Study. Hyperprolactinemia in end-stage renal disease and effects of frequent hemodialysis. Hemodial Int. 2017 Apr;21(2):190-196. doi: 10.1111/hdi.12489. Epub 2016 Oct 23.

  PMID: 27774730 DERIVED

• Chan CT, Greene T, Chertow GM, Kliger AS, Stokes JB, Beck GJ, Daugirdas JT, Kotanko P, Larive B, Levin NW, Mehta RL, Rocco M, Sanz J, Yang PC, Rajagopalan S; Frequent Hemodialysis Network Trial Group. Effects of frequent hemodialysis on ventricular volumes and left ventricular remodeling. Clin J Am Soc Nephrol. 2013 Dec;8(12):2106-16. doi: 10.2215/CJN.03280313. Epub 2013 Aug 22.

  PMID: 23970131 DERIVED

• Unruh ML, Larive B, Chertow GM, Eggers PW, Garg AX, Gassman J, Tarallo M, Finkelstein FO, Kimmel PL; FHN Trials Group. Effects of 6-times-weekly versus 3-times-weekly hemodialysis on depressive symptoms and self-reported mental health: Frequent Hemodialysis Network (FHN) Trials. Am J Kidney Dis. 2013 May;61(5):748-58. doi: 10.1053/j.ajkd.2012.11.047. Epub 2013 Jan 15.

  PMID: 23332990 DERIVED

• Kurella Tamura M, Unruh ML, Nissenson AR, Larive B, Eggers PW, Gassman J, Mehta RL, Kliger AS, Stokes JB; Frequent Hemodialysis Network (FHN) Trial Group. Effect of more frequent hemodialysis on cognitive function in the frequent hemodialysis network trials. Am J Kidney Dis. 2013 Feb;61(2):228-37. doi: 10.1053/j.ajkd.2012.09.009. Epub 2012 Nov 11.

  PMID: 23149295 DERIVED

• Hall YN, Larive B, Painter P, Kaysen GA, Lindsay RM, Nissenson AR, Unruh ML, Rocco MV, Chertow GM; Frequent Hemodialysis Network Trial Group. Effects of six versus three times per week hemodialysis on physical performance, health, and functioning: Frequent Hemodialysis Network (FHN) randomized trials. Clin J Am Soc Nephrol. 2012 May;7(5):782-94. doi: 10.2215/CJN.10601011. Epub 2012 Mar 15.

  PMID: 22422538 DERIVED

• 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 DERIVED

• Greene T, Daugirdas JT, Depner TA, Gotch F, Kuhlman M; Frequent Hemodialysis Network Study Group; National Institute of Diabetes and Digestive and Kidney Diseases; National Institutes of Health. Solute clearances and fluid removal in the frequent hemodialysis network trials. Am J Kidney Dis. 2009 May;53(5):835-44. doi: 10.1053/j.ajkd.2008.12.039. Epub 2009 Apr 1.

  PMID: 19339093 DERIVED

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

Study Officials

• Paul W. Eggers, Ph.D.

  NIDDK, NIH

  STUDY DIRECTOR

• Michael V. Rocco, M.D.

  Wake Forest University

  PRINCIPAL INVESTIGATOR

• Gerald J. Beck, Ph.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Alan S. Kliger, M.D.

  Hospital of St. Raphael

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 3, 2006
• First Posted: January 4, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 3, 2010

Record last verified: 2010-03

Locations

US (1)