Status:
COMPLETED
Frequent Hemodialysis Network: Daily Trial
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
13+ years
Phase:
PHASE2
PHASE3
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 foll...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00264758
Start Date
January 1 2006
End Date
March 1 2010
Last Update
July 3 2014
Active Locations (2)
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1
University of California at San Francisco - Core center plus other centers in California and Texas
San Francisco, California, United States, 94118
2
Renal Research Institute - Core center plus other centers in U.S. and Canada
New York, New York, United States, 10128