Frequent Hemodialysis Network: Nocturnal Trial

Status unconfirmed · Phase 2/Phase 3

Conditions studied: End Stage Renal Disease, Hemodialysis

In brief

The Frequent Hemodialysis (FHN) Nocturnal 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 12 months. Subjects will be randomized to conventional hemodialysis delivered three days per week home arm or to the six times per week nocturnal home hemodialysis arm which will follow any dialysis prescription provided their prescribed standardized Kt/V is at least 4.0 and treatment time is at least 6.0 hours, six times per week.

Key facts

Study ID

NCT00271999

Run by

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

People needed

150

Starts

2006-01-01

Expected to finish

2010-01-01

Last updated by the study team

2010-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with end stage renal disease requiring chronic renal replacement therapy
• Age ≥ 18 years,
• Achieved mean eKt/V of ≥ 1.1 during Baseline

You may not qualify if…

• GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
• Expectation that native kidneys will recover kidney function
• Current access is temporary non-tunneled catheter
• Unable to follow the nocturnal home hemodialysis training protocol for any reason, including inability to train the patient or the patient's caregiver
• Non-compliance with hemodialysis or peritoneal dialysis treatments in the past
• Medical conditions that would prevent the patient 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
• Current requirement for hemodialysis more than three times per week due to medical comorbidity (ultrafiltration session on fourth day per week not an exclusion criteria)
• Currently on daily or nocturnal HD, or less than 3 months since the patient discontinued daily or nocturnal HD
• Scheduled for living donor kidney transplant, change to peritoneal dialysis, or plans to relocate to an area outside of the referral area of one of the Clinical Centers within the next 12 months
• Expected geographic unavailability at the Clinical Center (for standard arm patients) or at home (for nocturnal arm patients) for > 2 consecutive weeks or > 5 weeks total during the next 12 months (excluding unavailability due to hospitalizations)
• Less than 3 months since the patient returned after acute rejection resulting in allograft failure
• Currently in acute care or chronic care hospital
• Life expectancy less than six months
• A medical history that might limit the individual'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 planning to become pregnant within the next fourteen months (patients require a higher dose of dialysis if pregnant). All female patients that have not gone through menopause will need to use an effective contraceptive method while enrolled in the study.
• Contraindication to heparin, including allergy or heparin induced thrombocytopenia
• Current use of investigational drugs or participation in an interventional 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

• Wake Forest University - Core center plus other centers in U.S. and Canada — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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