Frequent Hemodialysis Network: Daily Trial

July 2, 2014 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

245

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94118
        • University of California at San Francisco - Core center plus other centers in California and Texas
    • New York
      • New York, New York, United States, 10128
        • Renal Research Institute - Core center plus other centers in U.S. and Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Residual renal urea clearance > 3 mL/min per 35 L.
  2. Expectation that native kidneys will recover
  3. Vascular access being used for HD is a non-tunneled catheter
  4. Inability to come for in-center 6 days a week, including inability to arrange adequate transportation
  5. History of poor adherence to thrice weekly HD
  6. 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)
  7. Unable to verbally communicate in English or Spanish
  8. 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.
  9. Currently on daily or nocturnal HD, or less than 3 months since the subject discontinued daily or nocturnal HD
  10. Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD, or plans to relocate to another center within the next 14 months
  11. 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)
  12. Less than 3 months since the patient returned to HD after acute rejection resulting in allograft failure
  13. Currently in acute or chronic care hospital
  14. Life expectancy < 6 months
  15. 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)
  16. Current pregnancy, or actively planning to become pregnant in the next 12 months
  17. Contraindication to heparin, including allergy or heparin induced thrombocytopenia
  18. Current use of investigational drugs or participation in another clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial
  19. Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
  20. Unable or unwilling to provide informed consent or sign IRB-approved consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional hemodialysis
Three times per week in-center hemodialysis
Device: Conventional hemodialysis
Three times per week in-center hemodialysis
Experimental: Frequent hemodialysis
Six times per week in-center hemodialysis
Device: Frequent hemodialysis
Six times per week in-center hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
a composite of mortality with the change over 12 months in left ventricular mass
Time Frame: 12 months
12 months
a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
cardiovascular structure and function (change in LV mass)
Time Frame: 12 months
12 months
health-related quality of life/physical function (change in the PHC)
Time Frame: 12 months
12 months
depression/burden of illness (change in Beck Depression Inventory)
Time Frame: 12 months
12 months
nutrition (change in serum albumin)
Time Frame: 12 months
12 months
cognitive function (change in the Trail Making Test B)
Time Frame: 12 months
12 months
mineral metabolism (change in average predialysis serum phosphorus)
Time Frame: 12 months
12 months
clinical events (rate of non-access hospitalization or death)
Time Frame: 12 months
12 months
hypertension
Time Frame: 12 months
12 months
anemia
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Glenn Chertow, M.D., University of California, San Francisco
  • Principal Investigator: Nathan W. Levin, M.D., Renal Research Institute
  • Study Chair: Alan S. Kliger, M.D., Yale New Haven Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

December 12, 2005

First Submitted That Met QC Criteria

December 12, 2005

First Posted (Estimate)

December 13, 2005

Study Record Updates

Last Update Posted (Estimate)

July 3, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • beck-daily
  • 5U01DK066597 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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