← Back to Search

Behavioral Intervention

2 for Kidney Failure

Phase 2 & 3
Waitlist Available
Led By Michael V. Rocco, M.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study 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.

Eligible Conditions
  • Kidney Failure
  • Hemodialysis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
a composite of 12 month mortality and the change over 12 months in the SF-36 RAND physical health composite
composite of 12 month mortality and the change over 12 months in left ventricular mass by cine-MRI
Secondary outcome measures
cardiovascular structure/funct (change in LV mass over 12 mos), health-related QoL/phys funct (change over 12 mos in PHC)
clin events (rate of non-access hospital or death
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)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 2Experimental Treatment1 Intervention
Six times a week nocturnal home hemodialysis
Group II: 1Active Control1 Intervention
Three times a week conventional at home hemodialysis

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,360 Previous Clinical Trials
4,314,702 Total Patients Enrolled
10 Trials studying Kidney Failure
10,720 Patients Enrolled for Kidney Failure
Michael V. Rocco, M.D.Principal InvestigatorWake Forest University
Gerald J. Beck, Ph.D.Principal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
245 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Clinical Journal of the American Society of NephrologyJournal
Effects of Frequent Hemodialysis on Ventricular Volumes and Left Ventricular Remodeling
Chan, Christopher T., Tom Greene, Glenn M. Chertow, Alan S. Kliger, John B. Stokes, Gerald J. Beck, John T. Daugirdas, et al.. 2013. “Effects of Frequent Hemodialysis on Ventricular Volumes and Left Ventricular Remodeling”. Clinical Journal of the American Society of Nephrology. American Society of Nephrology (ASN). doi:10.2215/cjn.03280313.
Kidney InternationalJournal
The Effects of Frequent Nocturnal Home Hemodialysis: The Frequent Hemodialysis Network Nocturnal Trial
Rocco, Michael V., Robert S. Lockridge Jr., Gerald J. Beck, Paul W. Eggers, Jennifer J. Gassman, Tom Greene, Brett Larive, et al.. 2011. “The Effects of Frequent Nocturnal Home Hemodialysis: The Frequent Hemodialysis Network Nocturnal Trial”. Kidney International. Elsevier BV. doi:10.1038/ki.2011.213.
clinicaltrials.govStudy
Frequent Hemodialysis Network: Nocturnal Trial
2006. "Frequent Hemodialysis Network: Nocturnal Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00271999.
All > Dialysis
~8 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top