Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00271999
Status:
UNKNOWN
Last Update Posted:
2010-03-03
First Post:
2006-01-03
Brief Title:
Frequent Hemodialysis Network Nocturnal Trial
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
Frequent Hemodialysis Network Nocturnal Trial
Status:
UNKNOWN
Status Verified Date:
2010-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 KtV is at least 40 and treatment time is at least 60 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 KtV of 11 equivalent to a standardized KtV sKtV of 20 AND a minimum time of 25 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 KtV of 40 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 depressionburden 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 depressionburden 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
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 depressionburden 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 depressionburden 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U01DK066597 | NIH | None | httpsreporternihgovquickSearch5U01DK066597 |