Frequent Hemodialysis Network: Nocturnal Trial
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00271999
First received: January 3, 2006
Last updated: March 2, 2010
Last verified: March 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
End Stage Renal Disease Hemodialysis |
Behavioral: Nocturnal home hemodialysis |
Phase 2 Phase 3 |
| 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: Nocturnal Trial |
Resource links provided by NLM:
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Primary Outcome Measures:
- composite of 12 month mortality and the change over 12 months in left ventricular mass by cine-MRI, [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- a composite of 12 month mortality and 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/funct (change in LV mass over 12 mos), health-related QoL/phys funct (change over 12 mos in PHC), [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- depression/dis burden (change over 12 mos in Beck Depression Inv.),nutrition (change over 12 mos in serum albumin, cognitive funct (change over 12 mos in TrailMaking Test B),mineral metabolism (change over 12 mos in aveg pre-dialysis serum phosphorus), [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- clin events (rate of non-access hospital or death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- hypertension,anemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Three times a week conventional at home hemodialysis
|
Behavioral: Nocturnal home hemodialysis
Six times per week nocturnal home hemodialysis
|
|
Experimental: 2
Six times a week nocturnal home hemodialysis
|
Behavioral: Nocturnal home hemodialysis
Six times per week nocturnal home hemodialysis
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 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 ≥ 18 years,
- Achieved mean eKt/V of ≥ 1.1 during Baseline
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271999
Locations
| United States, North Carolina | |
| Wake Forest University - Core center plus other centers in U.S. and Canada | |
| Winston-Salem, North Carolina, United States, 27157 | |
Sponsors and Collaborators
Investigators
| Study Director: | Paul W. Eggers, Ph.D. | NIDDK, NIH |
| Principal Investigator: | Michael V. Rocco, M.D. | Wake Forest University |
| Principal Investigator: | Gerald J. Beck, Ph.D. | The Cleveland Clinic |
| Study Chair: | Alan S. Kliger, M.D. | Hospital of St. Raphael |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Paul Eggers, Ph.D., Project Officer, NIH/NIDDK |
| ClinicalTrials.gov Identifier: | NCT00271999 History of Changes |
| Other Study ID Numbers: | beck-night, 5 U01 DK)66597 |
| Study First Received: | January 3, 2006 |
| Last Updated: | March 2, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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 May 23, 2013