Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients - Full Text View

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) DaVita Dialysis Abbott Nutrition
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00561093

Purpose

Study of efficiency and safety of oral nutritional supplements with anti-inflammatory and antioxidative properties combined with an appetite stimulant with anti-inflammatory properties (pentoxiphylline) in treatment of malnutrition-inflammation-cachexia syndrome in maintenance hemodialysis patients

Condition	Intervention	Phase
Hypoalbuminemia Protein-Energy Malnutrition Inflammation Oxidative Stress Chronic Kidney Disease (CKD) Hemodialysis	Drug: pentoxiphylline Dietary Supplement: Nepro Dietary Supplement: anti-inflammatory module (similar to Oxepa) Drug: Placebo pill imitating pentoxiphylline Dietary Supplement: Placebo to imitate Nepro Dietary Supplement: Placebo to imitate anti-inflammatory module (similar to Oxepa)	Phase III

Genetics Home Reference related topics: aceruloplasminemia

MedlinePlus related topics: Dialysis Dietary Supplements Kidney Failure

Drug Information available for: Pentoxifylline Pentoxyl Nepro

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Pilot/Feasibility Randomized Control Trial to Examine the Effect of Oral Nutritional Supplements With Anti-Inflammatory/Anti-Oxidative Properties and Pentoxiphylline on Malnutrition-Inflammation-Cachexia Syndrome in Maintenance Hemodialysis Patients

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Change in serum albumin [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in body composition and measures of nutrition, inflammation, anemia, Health related quality of life (HRQOL), and tolerance [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	February 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Group A (n=25) Nepro (8 ounces) and Oxepa-similar anti-inflammatory module (2 ounces) AND pentoxiphylline (400 mg) while undergoing hemodialysis and the following non-dialysis day (6 days per week)	Drug: pentoxiphylline pentoxiphylline 400 mg daily, anti-inflammatory and appetite-stimulating while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week) Dietary Supplement: Nepro Nepro (8 ounces) one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week) Dietary Supplement: anti-inflammatory module (similar to Oxepa) Oxepa-similar anti-inflammatory module (2 ounces) while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
B: Experimental Group B (n=25) Nepro (8 ounces) and Oxepa-similar anti-inflammatory module (2 ounces) AND Placebo to imitate pentoxiphylline while undergoing hemodialysis and the following non-dialysis day (6 days per week)	Dietary Supplement: Nepro Nepro (8 ounces) one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week) Dietary Supplement: anti-inflammatory module (similar to Oxepa) Oxepa-similar anti-inflammatory module (2 ounces) while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week) Drug: Placebo pill imitating pentoxiphylline Placebo pill imitating pentoxiphylline 400 mg daily, to imitate the anti-inflammatory and appetite-stimulating pill while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
C: Experimental Group C (n=25) Placebo dietary supplement to imitate Nepro (8 ounces) and Oxepa-similar anti-inflammatory module (2 ounces) AND pentoxiphylline (400 mg) while undergoing hemodialysis and the following non-dialysis day (6 days per week)	Drug: pentoxiphylline pentoxiphylline 400 mg daily, anti-inflammatory and appetite-stimulating while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week) Dietary Supplement: Placebo to imitate Nepro Placebo to imitate Nepro (8 ounces), with less protein and calorie, one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week) Dietary Supplement: Placebo to imitate anti-inflammatory module (similar to Oxepa) Placebo to imitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingredients, while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
D: Placebo Comparator Group D (n=25) Placebo to imitate Nepro (8 ounces) and Oxepa-similar anti-inflammatory module (2 ounces) AND Placebo to imitate pentoxiphylline (400 mg) while undergoing hemodialysis and the following non-dialysis day (6 days per week)	Drug: Placebo pill imitating pentoxiphylline Placebo pill imitating pentoxiphylline 400 mg daily, to imitate the anti-inflammatory and appetite-stimulating pill while subjects undergo thrice weekly hemodialysis and during the following non-dialysis day (6 days per week) Dietary Supplement: Placebo to imitate Nepro Placebo to imitate Nepro (8 ounces), with less protein and calorie, one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week) Dietary Supplement: Placebo to imitate anti-inflammatory module (similar to Oxepa) Placebo to imitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingredients, while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 3 months on maintenance hemodialysis,
Last 3-month averaged serum albumin <4.0 g/dl,
Average monthly Kt/V>1.2,
Dialysis time between 3 and 5 hours,
Functioning AV graft or fistula or tunnel catheter that will not switch for 6 months,
Standardized dialysis treatment per DaVita protocol.
In case the averaged 3-month is not <4.0 g/dl but last month serum albumin <4.0 g/dl (worsening hypoalbuminemia) patient will be qualified, if 3-month averaged nPNA < 0.8 g/kg/day or a BMI < 20 kg/m2.

Exclusion Criteria:

Peritoneal dialysis
Terminal illnesses with life expectancy<6 months
Maintenance hemodialysis less than 5 months
Concurrent appetite stimulants
Use of IDPN in the past 2-3 months
Inability to follow and to comply with the instructions and guidelines
Likelihood of pregnancy or intention to become pregnant
Acute wasting condition or active systemic disease
Pulse chemo therapy
Non-compliance with dialysis treatment
Dialysis catheter that may switch soon.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561093

Locations

United States, California
Los Angeles Biomedical Research Institute (LABioMed) at Harbor-UCLA
Torrance, California, United States, 90502
DaVita Nutrition Services
Irvine, California, United States, 92618

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

DaVita Dialysis

Abbott Nutrition

Investigators

Principal Investigator:	Kamyar Kalantar-Zadeh, MD MPH PhD	LABioMed at Harbor-UCLA
Study Director:	Arezu Dezfuli, MD	LABioMed at Harbor-UCLA
Study Director:	Jennie Jing, MS	LABioMed at Harbor-UCLA

More Information

NIED (Nutrition & Inflammation Evaluation in Dialysis Patients) Study This link exits the ClinicalTrials.gov site

Publications:

Kalantar-Zadeh K, Braglia A, Chow J, Kwon O, Kuwae N, Colman S, Cockram DB, Kopple JD. An anti-inflammatory and antioxidant nutritional supplement for hypoalbuminemic hemodialysis patients: a pilot/feasibility study. J Ren Nutr. 2005 Jul;15(3):318-31.

Colman S, Bross R, Benner D, Chow J, Braglia A, Arzaghi J, Dennis J, Martinez L, Baldo DB, Agarwal V, Trundnowski T, Zitterkoph J, Martinez B, Khawar OS, Kalantar-Zadeh K. The Nutritional and Inflammatory Evaluation in Dialysis patients (NIED) study: overview of the NIED study and the role of dietitians. J Ren Nutr. 2005 Apr;15(2):231-43. Review.

Cooper A, Mikhail A, Lethbridge MW, Kemeny DM, Macdougall IC. Pentoxifylline improves hemoglobin levels in patients with erythropoietin-resistant anemia in renal failure. J Am Soc Nephrol. 2004 Jul;15(7):1877-82.

Kalantar-Zadeh K, Kilpatrick RD, Kuwae N, McAllister CJ, Alcorn H Jr, Kopple JD, Greenland S. Revisiting mortality predictability of serum albumin in the dialysis population: time dependency, longitudinal changes and population-attributable fraction. Nephrol Dial Transplant. 2005 Sep;20(9):1880-8. Epub 2005 Jun 14.

Kalantar-Zadeh K, Block G, McAllister CJ, Humphreys MH, Kopple JD. Appetite and inflammation, nutrition, anemia, and clinical outcome in hemodialysis patients. Am J Clin Nutr. 2004 Aug;80(2):299-307.

Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. Review.

Rammohan M, Kalantar-Zadeh K, Liang A, Ghossein C. Megestrol acetate in a moderate dose for the treatment of malnutrition-inflammation complex in maintenance dialysis patients. J Ren Nutr. 2005 Jul;15(3):345-55.

Kalantar-Zadeh K, Balakrishnan VS. The kidney disease wasting: inflammation, oxidative stress, and diet-gene interaction. Hemodial Int. 2006 Oct;10(4):315-25. Review.

Kalantar-Zadeh K. Recent advances in understanding the malnutrition-inflammation-cachexia syndrome in chronic kidney disease patients: What is next? Semin Dial. 2005 Sep-Oct;18(5):365-9. Review.

Kalantar-Zadeh K, Stenvinkel P, Bross R, Khawar OS, Rammohan M, Colman S, Benner D. Kidney insufficiency and nutrient-based modulation of inflammation. Curr Opin Clin Nutr Metab Care. 2005 Jul;8(4):388-96. Review.

Responsible Party:	LABioMed at Harbor-UCLA Medical Center ( Kamyar Kalantar-Zadeh, MD MPH PhD )
Study ID Numbers:	DK78012, Harbor-UCLA LABioMed # 12630
Study First Received:	November 19, 2007
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00561093
Health Authority:	United States: Institutional Review Board

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Hypoalbuminemia
Protein-energy malnutrition
Inflammation

Oxidative stress
Chronic Kidney disease (CKD) stage 5
maintenance hemodialysis

Study placed in the following topic categories:

Renal Insufficiency
Hematologic Diseases
Blood Protein Disorders
Kidney Failure, Chronic
Cachexia
Stress
Protein-Energy Malnutrition
Pentoxifylline
Inflammation

Malnutrition
Protein Deficiency
Urologic Diseases
Renal Insufficiency, Chronic
Hypoalbuminemia
Nutrition Disorders
Kidney Diseases
Deficiency Diseases
Kidney Failure

Additional relevant MeSH terms:

Hypoproteinemia
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009