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
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
  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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 School of Medicine
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):
Rocco MV, Lockridge RS Jr, Beck GJ, Eggers PW, Gassman JJ, Greene T, Larive B, Chan CT, Chertow GM, Copland M, Hoy CD, Lindsay RM, Levin NW, Ornt DB, Pierratos A, Pipkin MF, Rajagopalan S, Stokes JB, Unruh ML, Star RA, Kliger AS; Frequent Hemodialysis Network (FHN) Trial Group, Kliger A, Eggers P, Briggs J, Hostetter T, Narva A, Star R, Augustine B, Mohr P, Beck G, Fu Z, Gassman J, Greene T, Daugirdas J, Hunsicker L, Larive B, Li M, Mackrell J, Wiggins K, Sherer S, Weiss B, Rajagopalan S, Sanz J, Dellagrottaglie S, Kariisa M, Tran T, West J, Unruh M, Keene R, Schlarb J, Chan C, McGrath-Chong M, Frome R, Higgins H, Ke S, Mandaci O, Owens C, Snell C, Eknoyan G, Appel L, Cheung A, Derse A, Kramer C, Geller N, Grimm R, Henderson L, Prichard S, Roecker E, Rocco M, Miller B, Riley J, Schuessler R, Lockridge R, Pipkin M, Peterson C, Hoy C, Fensterer A, Steigerwald D, Stokes J, Somers D, Hilkin A, Lilli K, Wallace W, Franzwa B, Waterman E, Chan C, McGrath-Chong M, Copland M, Levin A, Sioson L, Cabezon E, Kwan S, Roger D, Lindsay R, Suri R, Champagne J, Bullas R, Garg A, Mazzorato A, Spanner E, Rocco M, Burkart J, Moossavi S, Mauck V, Kaufman T, Pierratos A, Chan W, Regozo K, Kwok S. The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial. Kidney Int. 2011 Nov;80(10):1080-91. doi: 10.1038/ki.2011.213. Epub 2011 Jul 20.

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 October 01, 2014