Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT00264758
Status:
COMPLETED
Last Update Posted:
2014-07-03
First Post:
2005-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Frequent Hemodialysis Network: Daily Trial
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Organization:
Study Overview
Official Title:
Frequent Hemodialysis Network: Daily Trial
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
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 Network (FHN) Daily 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 1 year. Subjects will be randomized to either conventional hemodialysis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life scale.
Detailed Description:
This trial is a randomized controlled trial recruiting subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada. A total of 250 ESRD patients receiving in-center HD will be randomized to continue with conventional HD, 3 days per week (control group), or switch to daily HD, 6 days per week (intervention group). Subjects will be treated and followed for 12 months. Two co-primary outcomes are designated: 1) a composite of mortality with the change over 12 months in left ventricular mass, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. In addition, main secondary outcomes have been designated for each of seven outcome domains: 1) cardiovascular structure and function (change in LV mass), 2) health-related quality of life/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 objectives of this study are the following:
Feasibility:
1. To determine the feasibility of recruiting and retaining patients in a randomized trial of six times per week in-center daily HD versus conventional three times per week in-center HD.
2. To determine patient adherence with and acceptance of in-center daily HD, and to identify reasons for discontinuation from or nonadherence with the therapy.
Safety:
3. To determine the safety of in-center daily HD with a particular focus on vascular access events and participant burden.
Efficacy:
4. To evaluate the efficacy of in-center daily HD compared to conventional three times per week HD on two co-primary outcomes: i) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging (MRI), and ii) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite score (PHC).
5. To determine the effect of in-center daily HD on nine secondary outcome domains: i) cardiovascular structure and function, ii) health-related quality of life and physical function, iii) depression/burden of illness, iv) nutrition and inflammation, v) cognitive function, vi) mineral metabolism, vii) clinical events, viii) hypertension, and ix) anemia.
Characterization of the Intervention
6. To better understand the complex therapy of in-center daily HD, by evaluating solute clearance, treatment times, volume removal, and non-dialytic factors such as differences in the frequency of medical surveillance and treatment.
Implementation:
7. To determine the feasibility of implementing in-center daily HD in practice, by evaluating barriers to implementation such as the incremental cost of daily HD compared to 3 times per week conventional HD.
The objectives of this study are the following:
Feasibility:
1. To determine the feasibility of recruiting and retaining patients in a randomized trial of six times per week in-center daily HD versus conventional three times per week in-center HD.
2. To determine patient adherence with and acceptance of in-center daily HD, and to identify reasons for discontinuation from or nonadherence with the therapy.
Safety:
3. To determine the safety of in-center daily HD with a particular focus on vascular access events and participant burden.
Efficacy:
4. To evaluate the efficacy of in-center daily HD compared to conventional three times per week HD on two co-primary outcomes: i) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging (MRI), and ii) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite score (PHC).
5. To determine the effect of in-center daily HD on nine secondary outcome domains: i) cardiovascular structure and function, ii) health-related quality of life and physical function, iii) depression/burden of illness, iv) nutrition and inflammation, v) cognitive function, vi) mineral metabolism, vii) clinical events, viii) hypertension, and ix) anemia.
Characterization of the Intervention
6. To better understand the complex therapy of in-center daily HD, by evaluating solute clearance, treatment times, volume removal, and non-dialytic factors such as differences in the frequency of medical surveillance and treatment.
Implementation:
7. To determine the feasibility of implementing in-center daily HD in practice, by evaluating barriers to implementation such as the incremental cost of daily HD compared to 3 times per week conventional HD.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5U01DK066597 | NIH | None | https://reporter.nih.gov/quic… | View |