Frequent Hemodialysis Network: Daily Trial

End Stage Renal Disease Clinical Trial

Official title:

Frequent Hemodialysis Network: Daily Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264758
• Other study ID #: beck-daily
• Secondary ID: 5U01DK066597
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 12, 2005
• Last updated: July 2, 2014
• Start date: January 2006
• Est. completion date: March 2010

Study information

• Verified date: July 2014
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Conventional hemodialysis
Three times per week in-center hemodialysis
• Frequent hemodialysis
Six times per week in-center hemodialysis

Locations

Country	Name	City	State
United States	Renal Research Institute - Core center plus other centers in U.S. and Canada	New York	New York
United States	University of California at San Francisco - Core center plus other centers in California and Texas	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Chan CT, Chertow GM, Daugirdas JT, Greene TH, Kotanko P, Larive B, Pierratos A, Stokes JB; Frequent Hemodialysis Network Daily Trial Group. Effects of daily hemodialysis on heart rate variability: results from the Frequent Hemodialysis Network (FHN) Daily — View Citation

Daugirdas JT, Greene T, Rocco MV, Kaysen GA, Depner TA, Levin NW, Chertow GM, Ornt DB, Raimann JG, Larive B, Kliger AS; FHN Trial Group. Effect of frequent hemodialysis on residual kidney function. Kidney Int. 2013 May;83(5):949-58. doi: 10.1038/ki.2012.4 — View Citation

FHN Trial Group, Chertow GM, Levin NW, Beck GJ, Depner TA, Eggers PW, Gassman JJ, Gorodetskaya I, Greene T, James S, Larive B, Lindsay RM, Mehta RL, Miller B, Ornt DB, Rajagopalan S, Rastogi A, Rocco MV, Schiller B, Sergeyeva O, Schulman G, Ting GO, Unruh — View Citation

Kliger AS; Frequent Hemodialysis Network Study Group. High-frequency hemodialysis: rationale for randomized clinical trials. Clin J Am Soc Nephrol. 2007 Mar;2(2):390-2. Epub 2006 Dec 20. Review. — View Citation

Rocco MV, Larive B, Eggers PW, Beck GJ, Chertow GM, Levin NW, Kliger AS; FHN Trial Group. Baseline characteristics of participants in the Frequent Hemodialysis Network (FHN) daily and nocturnal trials. Am J Kidney Dis. 2011 Jan;57(1):90-100. doi: 10.1053/ — View Citation

Suri RS, Garg AX, Chertow GM, Levin NW, Rocco MV, Greene T, Beck GJ, Gassman JJ, Eggers PW, Star RA, Ornt DB, Kliger AS; Frequent Hemodialysis Network Trial Group. Frequent Hemodialysis Network (FHN) randomized trials: study design. Kidney Int. 2007 Feb;71(4):349-59. Epub 2006 Dec 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a composite of mortality with the change over 12 months in left ventricular mass		12 months	Yes
Primary	a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite.		12 months	Yes
Secondary	cardiovascular structure and function (change in LV mass)		12 months	Yes
Secondary	health-related quality of life/physical function (change in the PHC)		12 months	Yes
Secondary	depression/burden of illness (change in Beck Depression Inventory)		12 months	Yes
Secondary	nutrition (change in serum albumin)		12 months	Yes
Secondary	cognitive function (change in the Trail Making Test B)		12 months	Yes
Secondary	mineral metabolism (change in average predialysis serum phosphorus)		12 months	Yes
Secondary	clinical events (rate of non-access hospitalization or death)		12 months	Yes
Secondary	hypertension		12 months	Yes
Secondary	anemia		12 months	Yes