Frequent Hemodialysis Network: Daily Trial
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00264758 |
Recruitment Status :
Completed
First Posted : December 13, 2005
Last Update Posted : July 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
End Stage Renal Disease | Device: Conventional hemodialysis Device: Frequent hemodialysis | Phase 2 Phase 3 |

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 |
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
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Device: Frequent hemodialysis
Six times per week in-center hemodialysis |
- a composite of mortality with the change over 12 months in left ventricular mass [ Time Frame: 12 months ]
- a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. [ Time Frame: 12 months ]
- cardiovascular structure and function (change in LV mass) [ Time Frame: 12 months ]
- health-related quality of life/physical function (change in the PHC) [ Time Frame: 12 months ]
- depression/burden of illness (change in Beck Depression Inventory) [ Time Frame: 12 months ]
- nutrition (change in serum albumin) [ Time Frame: 12 months ]
- cognitive function (change in the Trail Making Test B) [ Time Frame: 12 months ]
- mineral metabolism (change in average predialysis serum phosphorus) [ Time Frame: 12 months ]
- clinical events (rate of non-access hospitalization or death) [ Time Frame: 12 months ]
- hypertension [ Time Frame: 12 months ]
- anemia [ Time Frame: 12 months ]

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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 |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

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
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 |
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 |
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 |
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 |
randomized controlled clinical trial hemodialysis end stage renal disease |
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |