Frequent Hemodialysis Network: Daily Trial

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Device: Conventional hemodialysis; Device: Frequent hemodialysis

• Registration Number: NCT00264758
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Study Timeline

• Study First Submitted: 2005-12-12
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-13
• Study Start: 2006-01
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-02
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

1. Patients with end stage renal disease requiring chronic renal replacement therapy
2. Age 13 years or greater
3. Achieved mean eKt/V of > 1.0 on at least two baseline sessions
4. Weight 30 kg or greater

Exclusion Criteria

1. Residual renal urea clearance > 3 mL/min per 35 L.
2. Expectation that native kidneys will recover
3. Vascular access being used for HD is a non-tunneled catheter
4. Inability to come for in-center 6 days a week, including inability to arrange adequate transportation
5. History of poor adherence to thrice weekly HD
6. Medical conditions that would prevent the subject 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. Requires HD > 3 times per week due to medical co-morbidity (such as, but not limited to: systemic oxalosis, or requiring total parenteral nutrition). Occasional ultrafiltration on a fourth day per week is not an exclusion criterion.
9. Currently on daily or nocturnal HD, or less than 3 months since the subject discontinued daily or nocturnal HD
10. Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD, or plans to relocate to another center within the next 14 months
11. Expected geographic unavailability at a participating HD unit for > 2 consecutive weeks or > 4 weeks total during the next 14 months (excluding unavailability due to hospitalizations) (frequent HD subjects who leave for vacation may resort back to conventional HD during these time periods)
12. Less than 3 months since the patient returned to HD after acute rejection resulting in allograft failure
13. Currently in acute or chronic care hospital
14. Life expectancy < 6 months
15. A medical history that might limit the subject'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 actively planning to become pregnant in the next 12 months
17. Contraindication to heparin, including allergy or heparin induced thrombocytopenia
18. Current use of investigational drugs or participation in another 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional hemodialysis	Conventional hemodialysis	Three times per week in-center hemodialysis
Frequent hemodialysis	Frequent hemodialysis	Six times per week in-center hemodialysis

Primary Outcome Measures

Name	Time	Method
a composite of mortality with the change over 12 months in left ventricular mass	12 months
a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite.	12 months

Secondary Outcome Measures

Name	Time	Method
mineral metabolism (change in average predialysis serum phosphorus)	12 months
health-related quality of life/physical function (change in the PHC)	12 months
hypertension	12 months
clinical events (rate of non-access hospitalization or death)	12 months
depression/burden of illness (change in Beck Depression Inventory)	12 months
cognitive function (change in the Trail Making Test B)	12 months
anemia	12 months
cardiovascular structure and function (change in LV mass)	12 months
nutrition (change in serum albumin)	12 months

Trial Locations

Locations (2)

University of California at San Francisco - Core center plus other centers in California and Texas; 🇺🇸 San Francisco, California, United States

Renal Research Institute - Core center plus other centers in U.S. and Canada; 🇺🇸 New York, New York, United States