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Frequent Hemodialysis Network: Daily Trial

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ClinicalTrials.gov Identifier: NCT00264758
Recruitment Status : Completed
First Posted : December 13, 2005
Last Update Posted : July 3, 2014
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
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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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Device: Conventional hemodialysis Device: Frequent hemodialysis Phase 2 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Frequent Hemodialysis Network: Daily Trial
Study Start Date : January 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. a composite of mortality with the change over 12 months in left ventricular mass [ Time Frame: 12 months ]
  2. a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. cardiovascular structure and function (change in LV mass) [ Time Frame: 12 months ]
  2. health-related quality of life/physical function (change in the PHC) [ Time Frame: 12 months ]
  3. depression/burden of illness (change in Beck Depression Inventory) [ Time Frame: 12 months ]
  4. nutrition (change in serum albumin) [ Time Frame: 12 months ]
  5. cognitive function (change in the Trail Making Test B) [ Time Frame: 12 months ]
  6. mineral metabolism (change in average predialysis serum phosphorus) [ Time Frame: 12 months ]
  7. clinical events (rate of non-access hospitalization or death) [ Time Frame: 12 months ]
  8. hypertension [ Time Frame: 12 months ]
  9. anemia [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264758


Locations
United States, California
University of California at San Francisco - Core center plus other centers in California and Texas
San Francisco, California, United States, 94118
United States, New York
Renal Research Institute - Core center plus other centers in U.S. and Canada
New York, New York, United States, 10128
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Study Director: Paul W. Eggers, Ph.D. NIDDK, NIH
Principal Investigator: 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
Study Chair: Alan S. Kliger, M.D. Yale New Haven Health System
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00264758     History of Changes
Other Study ID Numbers: beck-daily
5U01DK066597 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2005    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
randomized controlled clinical trial
hemodialysis
end stage renal disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency