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End Stage Renal DiseasePhase 2/3NCT00264758

Frequent Hemodialysis Network: Daily Trial

A Phase 2/3 study testing Conventional hemodialysis and Frequent hemodialysis in people with End Stage Renal Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 years and older
Conditions the study is for
End Stage Renal Disease
What is being tested?
Conventional hemodialysis and Frequent hemodialysis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
245 participants
Where
2 sitesUnited States
Study dates
Jan 2006to Mar 2010
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 20Show fewer
  • Unable to verbally communicate in English or Spanish
  • Requires HD > 3 times per week due to medical co-morbidity (such as, but not limited to: systemic oxalosis, or requiring total parenteral nutrition). Occasional ultrafiltration on a fourth day per week is not an exclusion criterion.
  • 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
  • Contraindication to heparin, including allergy or heparin induced thrombocytopenia
  • Current use of investigational drugs or participation in another clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
  • Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
  • Unable or unwilling to provide informed consent or sign IRB-approved consent form

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

    New York, New York, 10128

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

    San Francisco, California, 94118

Other trials in United States

About this study

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.

Read the detailed description

This trial is a randomized controlled trial recruiting subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada. A total of 250 ESRD patients receiving in-center HD will be randomized to continue with conventional HD, 3 days per week (control group), or switch to daily HD, 6 days per week (intervention group). Subjects will be treated and followed for 12 months. Two co-primary outcomes are designated: 1) a composite of mortality with the change over 12 months in left ventricular mass, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. In addition, main secondary outcomes have been designated for each of seven outcome domains: 1) cardiovascular structure and function (change in LV mass), 2) health-related quality of life/physical function (change in the PHC), 3) depression/burden of illness (change in Beck Depression Inventory), 4) nutrition (change in serum albumin), 5) cognitive function (change in the Trail Making Test B), 6) mineral metabolism (change in average predialysis serum phosphorus), and 7) clinical events (rate of non-access hospitalization or death). Hypertension and anemia are also main outcome domains, but without designation of single first priority outcomes.

The objectives of this study are the following:

Feasibility:

  1. To determine the feasibility of recruiting and retaining patients in a randomized trial of six times per week in-center daily HD versus conventional three times per week in-center HD.
  2. To determine patient adherence with and acceptance of in-center daily HD, and to identify reasons for discontinuation from or nonadherence with the therapy. Safety:
  3. To determine the safety of in-center daily HD with a particular focus on vascular access events and participant burden. Efficacy:
  4. To evaluate the efficacy of in-center daily HD compared to conventional three times per week HD on two co-primary outcomes: i) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging (MRI), and ii) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite score (PHC).
  5. To determine the effect of in-center daily HD on nine secondary outcome domains: i) cardiovascular structure and function, ii) health-related quality of life and physical function, iii) depression/burden of illness, iv) nutrition and inflammation, v) cognitive function, vi) mineral metabolism, vii) clinical events, viii) hypertension, and ix) anemia. Characterization of the Intervention
  6. To better understand the complex therapy of in-center daily HD, by evaluating solute clearance, treatment times, volume removal, and non-dialytic factors such as differences in the frequency of medical surveillance and treatment. Implementation:
  7. To determine the feasibility of implementing in-center daily HD in practice, by evaluating barriers to implementation such as the incremental cost of daily HD compared to 3 times per week conventional HD.
Being tested
Conventional hemodialysis, Frequent hemodialysis
Keywords
randomized controlled clinical trial, hemodialysis, end stage renal disease
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional hemodialysisDevice

    Three times per week in-center hemodialysis

  • Frequent hemodialysisDevice

    Six times per week in-center hemodialysis

Study groups in NCT00264758
Study groupRoleWhat they receive
Conventional hemodialysisActive comparatorThree times per week in-center hemodialysis
Receives: Device: Conventional hemodialysis
Frequent hemodialysisExperimentalSix times per week in-center hemodialysis
Receives: Device: Frequent hemodialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

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

    Measured: 12 months

Secondary outcomes (9)

  1. cardiovascular structure and function (change in LV mass)

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

  4. nutrition (change in serum albumin)

    Measured: 12 months

  5. cognitive function (change in the Trail Making Test B)

    Measured: 12 months

  6. mineral metabolism (change in average predialysis serum phosphorus)

    Measured: 12 months

  7. clinical events (rate of non-access hospitalization or death)

    Measured: 12 months

  8. hypertension

    Measured: 12 months

  9. anemia

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00264758
Sponsor's protocol ID
beck-daily
Other IDs
5U01DK066597
Status last verified
Jul 2014
First submitted
12 Dec 2005
Last updated
3 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17164834

  • 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.

    PubMed 17699439

  • 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.

    PubMed 21122961

  • 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.

    PubMed 21091062

  • 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.

    PubMed 23344474

  • 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.

    PubMed 24078335

  • 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.

    PubMed 40080097

  • 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.

    PubMed 37651553

  • 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.

    PubMed 31826326

  • 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.

    PubMed 29621747

  • 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.

    PubMed 28301073

  • 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.

    PubMed 28094031

  • 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.

    PubMed 25402657

  • 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.

    PubMed 23970131

  • 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.

    PubMed 23332990

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Conventional hemodialysis and Frequent hemodialysis in people with End Stage Renal Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a composite of mortality with the change over 12 months in left ventricular mass (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00264758, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2014.

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