Frequent Hemodialysis Network: Daily Trial - Full Text View

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00264758

Purpose

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 hemodialyis 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	Intervention	Phase
End Stage Renal Disease Hemodialysis	Behavioral: Frequent hemodialysis	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Frequent Hemodialysis Network: Daily Trial

Resource links provided by NLM:

MedlinePlus related topics: Dialysis High Blood Pressure Kidney Failure

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

a composite of mortality with the change over 12 months in left ventricular mass [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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

Estimated Enrollment:	250
Study Start Date:	January 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Three times per week conventional in-center hemodialysis	Behavioral: Frequent hemodialysis Six times per week in-center hemodialysis
Experimental: 2 Six times per week in-center hemodialysis	Behavioral: Frequent hemodialysis Six times per week in-center hemodialysis

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:

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.
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:
To determine the safety of in-center daily HD with a particular focus on vascular access events and participant burden.

Efficacy:
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).
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
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:
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.

Eligibility

Ages Eligible for Study:	13 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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.	Hospital of St. Raphael

More Information

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. Epub 2006 Dec 13.

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. Epub 2006 Dec 20. Review. No abstract available.

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

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. Epub 2010 Nov 20.

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. Epub 2010 Jul 8.

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. Epub 2009 Apr 1.

Responsible Party:	Paul Eggers, Ph.D., Project Officer, NIH/NIDDK
ClinicalTrials.gov Identifier:	NCT00264758 History of Changes
Other Study ID Numbers:	beck-daily, 5 U01 DK066597-03
Study First Received:	December 12, 2005
Last Updated:	March 2, 2010
Health Authority:	United States: Federal Government

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

ClinicalTrials.gov processed this record on February 12, 2012