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Frequent Hemodialysis Network: Nocturnal Trial

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ClinicalTrials.gov Identifier: NCT00271999
Recruitment Status : Unknown
Verified March 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Active, not recruiting
First Posted : January 4, 2006
Last Update Posted : March 3, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date  ICMJE January 3, 2006
First Posted Date  ICMJE January 4, 2006
Last Update Posted Date March 3, 2010
Study Start Date  ICMJE January 2006
Estimated Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
  • composite of 12 month mortality and the change over 12 months in left ventricular mass by cine-MRI, [ Time Frame: 12 months ]
  • a composite of 12 month mortality and the change over 12 months in the SF-36 RAND physical health composite [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2006)
  • 1) a composite of 14 month mortality and the change over 14 months in left ventricular mass by cine-MRI
  • 2) a composite of 14 month mortality and the change over 14 months in the SF-36 RAND physical health composite
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2008)
  • 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 ]
  • 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 ]
  • clin events (rate of non-access hospital or death [ Time Frame: 12 months ]
  • hypertension,anemia [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2006)
  • 1)cardiovascular structure and function (change in LV mass over 14 months)
  • 2)health-related quality of life/physical function (change over 14 months in the PHC)
  • 3)depression/disease burden (change over 14 months in Beck Depression Inventory)
  • 4)nutrition (change over 14 months in serum albumin
  • 5)cognitive function (change over 14 months in the Trail Making Test B)
  • 6)mineral metabolism (change over 14 months in average pre-dialysis serum phosphorus)
  • 7)clinical events (rate of non-access hospitalizations or death
  • 8)hypertension
  • 9)anemia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Frequent Hemodialysis Network: Nocturnal Trial
Official Title  ICMJE Frequent Hemodialysis Network: Nocturnal Trial
Brief Summary 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.
Detailed Description

This trial is a randomized, unblinded study of six times per week nocturnal home hemodialysis versus three times per week home hemodialysis. A target of 150 patients will be enrolled into this study with equal allocation in each arm, stratified by Clinical Center and residual renal function. All patients will be assessed for suitability for nocturnal home hemodialysis using a standardized method prior to patients entering the baseline portion of this protocol. The minimum dialysis dose in the standard arm will be an equilibrated Kt/V of 1.1 (equivalent to a standardized Kt/V (sKt/V) of 2.0) AND a minimum time of 2.5 hours. In the nocturnal arm there will be a minimum prescription of six hours per session for six days per week AND a minimum standardized Kt/V of 4.0. Patients will be followed for 12 months.

Two co-primary outcomes are designated: 1) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite, and 2) the change over 12 months in left ventricular mass. In addition, first priority secondary outcomes have been designated for seven outcome domains: 1) cardiovascular structure and function (change in LV mass), 2) 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 cost-effectiveness of the two interventions will also be compared.

The objectives of the study are as follows:

Feasibility:

  1. To determine the feasibility of recruiting and retaining patients in a randomized trial of six times per week at-home nocturnal hemodialysis versus standard three times per week at home hemodialysis.
  2. To determine patient adherence and acceptance of nocturnal hemodialysis, and to identify reasons for discontinuation or noncompliance to the interventions.

    Safety:

  3. To determine the safety of the nocturnal hemodialysis intervention, with a particular emphasis on vascular access and patient burden.

    Efficacy:

  4. To evaluate the efficacy of six times per week nocturnal HD compared to conventional three times per week HD on two co-primary outcomes: i) a composite of mortality with the change over 14 months in left ventricular mass by magnetic resonance imaging, and ii) a composite of mortality with the change over 14 months in the SF-36 RAND physical health composite score (PHC).
  5. To determine the effect of six times per week nocturnal HD on nine secondary outcome domains: i) cardiovascular structure and function, ii) physical function, iii) depression/burden of illness, iv) nutrition, v) cognitive function, vi) mineral metabolism, vii) clinical events, viii) hypertension, and ix) anemia.

    Characterization of Interventions:

  6. To characterize the six times per week nocturnal home hemodialysis intervention in comparison to standard home three times per week hemodialysis, including evaluation of small and middle molecule solute clearance, treatment time, and volume removal.

    Implementation:

  7. To determine the feasibility of implementing six times per week nocturnal home hemodialysis in practice, including evaluation of barriers to implementation such as the home environment and any potential incremental costs of nocturnal home hemodialysis compared to three times per week conventional hemodialysis. An evaluation of the cost effectiveness of six times per week home nocturnal HD relative compared to 3 times per week conventional home HD will be performed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • End Stage Renal Disease
  • Hemodialysis
Intervention  ICMJE Behavioral: Nocturnal home hemodialysis
Six times per week nocturnal home hemodialysis
Study Arms  ICMJE
  • Active Comparator: 1
    Three times a week conventional at home hemodialysis
    Intervention: Behavioral: Nocturnal home hemodialysis
  • Experimental: 2
    Six times a week nocturnal home hemodialysis
    Intervention: Behavioral: Nocturnal home hemodialysis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 10, 2008)
150
Original Enrollment  ICMJE
 (submitted: January 3, 2006)
250
Estimated Study Completion Date  ICMJE January 2010
Estimated Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Expectation that native kidneys will recover kidney function
  3. Current access is temporary non-tunneled catheter
  4. Unable to follow the nocturnal home hemodialysis training protocol for any reason, including inability to train the patient or the patient's caregiver
  5. Non-compliance with hemodialysis or peritoneal dialysis treatments in the past
  6. 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)
  7. Unable to verbally communicate in English or Spanish
  8. 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)
  9. Currently on daily or nocturnal HD, or less than 3 months since the patient discontinued daily or nocturnal HD
  10. 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
  11. 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)
  12. Less than 3 months since the patient returned after acute rejection resulting in allograft failure
  13. Currently in acute care or chronic care hospital
  14. Life expectancy less than six months
  15. 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
  16. 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.
  17. Contraindication to heparin, including allergy or heparin induced thrombocytopenia
  18. 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
  19. Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
  20. Unable or unwilling to provide informed consent or sign IRB-approved consent form
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00271999
Other Study ID Numbers  ICMJE beck-night
5U01DK066597 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Eggers, Ph.D., Project Officer, NIH/NIDDK
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP