Frequent Hemodialysis Network: Nocturnal Trial

End Stage Renal Disease Clinical Trial

Official title: Frequent Hemodialysis Network: Nocturnal Trial

Status Unknown status

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic

• NCT number: NCT00271999
• Study type: Interventional
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Status: Unknown status
• Phase: Phase 2/Phase 3
• Start date: January 2006
• Completion date: January 2010