Frequent Hemodialysis Network: Daily Trial

Completed · Phase 2/Phase 3

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT00264758

Run by

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

People needed

245

Starts

2006-01-01

Expected to finish

2010-03-01

Last updated by the study team

2014-07-03

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.