Frequent Hemodialysis Network: Daily Trial

NCT00264758 | Completed Phase 2 DMC

• 2 other identifiers: beck-daily5U01DK066597
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 2

Brief Summary

The Frequent Hemodialysis Network (FHN) Daily 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 1 year. Subjects will be randomized to either conventional hemodialysis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life scale.

Conditions

End Stage Renal Disease

Keywords

randomized controlled clinical trial; hemodialysis; end stage renal disease

Outcome Measures

Primary Outcomes (2)

• a composite of mortality with the change over 12 months in left ventricular mass

  12 months

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

  12 months

Secondary Outcomes (9)

• cardiovascular structure and function (change in LV mass)

  12 months

• health-related quality of life/physical function (change in the PHC)

  12 months

• depression/burden of illness (change in Beck Depression Inventory)

  12 months

• nutrition (change in serum albumin)

  12 months

• cognitive function (change in the Trail Making Test B)

  12 months

Study Arms (2)

Conventional hemodialysis

ACTIVE COMPARATOR

Three times per week in-center hemodialysis

Device: Conventional hemodialysis

Frequent hemodialysis

EXPERIMENTAL

Six times per week in-center hemodialysis

Device: Frequent hemodialysis

Interventions

Conventional hemodialysis DEVICE

Three times per week in-center hemodialysis

Conventional hemodialysis

Frequent hemodialysis DEVICE

Six times per week in-center hemodialysis

Frequent hemodialysis

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with end stage renal disease requiring chronic renal replacement therapy
• Age 13 years or greater
• Achieved mean eKt/V of \> 1.0 on at least two baseline sessions
• Weight 30 kg or greater

You may not qualify if:

• Residual renal urea clearance \> 3 mL/min per 35 L.
• Expectation that native kidneys will recover
• Vascular access being used for HD is a non-tunneled catheter
• Inability to come for in-center 6 days a week, including inability to arrange adequate transportation
• History of poor adherence to thrice weekly HD
• Medical conditions that would prevent the subject 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 subject discontinued daily or nocturnal HD
• Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD, or plans to relocate to another center within the next 14 months
• Expected geographic unavailability at a participating HD unit for \> 2 consecutive weeks or \> 4 weeks total during the next 14 months (excluding unavailability due to hospitalizations) (frequent HD subjects who leave for vacation may resort back to conventional HD during these time periods)
• Less than 3 months since the patient returned to HD after acute rejection resulting in allograft failure
• Currently in acute or chronic care hospital
• Life expectancy \< 6 months
• A medical history that might limit the subject'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 actively planning to become pregnant in the next 12 months

Sponsors & Collaborators

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

Study Sites (2)

University of California at San Francisco - Core center plus other centers in California and Texas

San Francisco, California, 94118, United States

Location

Renal Research Institute - Core center plus other centers in U.S. and Canada

New York, New York, 10128, United States

Location

Related Publications (20)

• 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

• Rocco MV, Larive B, Eggers PW, Beck GJ, Chertow GM, Levin NW, Kliger AS; FHN Trial Group. Baseline characteristics of participants in the Frequent Hemodialysis Network (FHN) daily and nocturnal trials. Am J Kidney Dis. 2011 Jan;57(1):90-100. doi: 10.1053/j.ajkd.2010.08.024. Epub 2010 Nov 30.

  PMID: 21122961 RESULT

• FHN Trial Group; Chertow GM, Levin NW, Beck GJ, Depner TA, Eggers PW, Gassman JJ, Gorodetskaya I, Greene T, James S, Larive B, Lindsay RM, Mehta RL, Miller B, Ornt DB, Rajagopalan S, Rastogi A, Rocco MV, Schiller B, Sergeyeva O, Schulman G, Ting GO, Unruh ML, Star RA, Kliger AS. In-center hemodialysis six times per week versus three times per week. N Engl J Med. 2010 Dec 9;363(24):2287-300. doi: 10.1056/NEJMoa1001593. Epub 2010 Nov 20.

  PMID: 21091062 RESULT

• Daugirdas JT, Greene T, Rocco MV, Kaysen GA, Depner TA, Levin NW, Chertow GM, Ornt DB, Raimann JG, Larive B, Kliger AS; FHN Trial Group. Effect of frequent hemodialysis on residual kidney function. Kidney Int. 2013 May;83(5):949-58. doi: 10.1038/ki.2012.457. Epub 2013 Jan 23.

  PMID: 23344474 RESULT

• Chan CT, Chertow GM, Daugirdas JT, Greene TH, Kotanko P, Larive B, Pierratos A, Stokes JB; Frequent Hemodialysis Network Daily Trial Group. Effects of daily hemodialysis on heart rate variability: results from the Frequent Hemodialysis Network (FHN) Daily Trial. Nephrol Dial Transplant. 2014 Jan;29(1):168-78. doi: 10.1093/ndt/gft212. Epub 2013 Sep 26.

  PMID: 24078335 RESULT

• Moloney BM, Chertow GM, Mc Causland FR. Association of Diabetes with Heart Rate Variability during Hemodialysis: Insights from the Frequent Hemodialysis Network Daily Trial. Kidney360. 2025 Mar 13;6(7):1127-1134. doi: 10.34067/KID.0000000765.

  PMID: 40080097 DERIVED

• 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

• Raimann JG, Abbas SR, Liu L, Zhu F, Larive B, Kotanko P, Levin NW, Kaysen GA; FHN Trial. Agreement of single- and multi-frequency bioimpedance measurements in hemodialysis patients: an ancillary study of the Frequent Hemodialysis Network Daily Trial. Nephron Clin Pract. 2014;128(1-2):115-26. doi: 10.1159/000366447. Epub 2014 Nov 7.

  PMID: 25402657 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

• 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, Schiller BM, Yang PC, Rajagopalan S; Frequent Hemodialysis Network (FHN) Trial Group. Determinants of left ventricular mass in patients on hemodialysis: Frequent Hemodialysis Network (FHN) Trials. Circ Cardiovasc Imaging. 2012 Mar;5(2):251-61. doi: 10.1161/CIRCIMAGING.111.969923. Epub 2012 Feb 23.

  PMID: 22360996 DERIVED

• Chan CT, Levin NW, Chertow GM, Larive B, Schulman G, Kotanko P; Frequent Hemodialysis Network Daily Trial Group. Determinants of cardiac autonomic dysfunction in ESRD. Clin J Am Soc Nephrol. 2010 Oct;5(10):1821-7. doi: 10.2215/CJN.03080410. Epub 2010 Jul 8.

  PMID: 20616163 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

• Glenn Chertow, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Nathan W. Levin, M.D.

  Renal Research Institute

  PRINCIPAL INVESTIGATOR

• Gerald J. Beck, Ph.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Alan S. Kliger, M.D.

  Yale New Haven Health System

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 13, 2005
• Study Start: January 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 3, 2014

Record last verified: 2014-07

Locations

US (2)