Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients

NCT00561093 | Completed Phase 3 DMC

• 3 other identifiers: R21 DK78012 (completed)Harbor-UCLA LABioMed # 12630R21DK078012
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hypoalbuminemia; Protein-energy Malnutrition; Inflammation; Oxidative Stress; Chronic Kidney Disease (CKD) Hemodialysis

Keywords

Hypoalbuminemia; Protein-energy malnutrition; Inflammation; Oxidative stress; Chronic Kidney disease (CKD) stage 5; maintenance hemodialysis

Outcome Measures

Primary Outcomes (1)

• Change in serum albumin

  16 weeks

Secondary Outcomes (1)

• Changes in body composition and measures of nutrition, inflammation, anemia, Health related quality of life (HRQOL), and tolerance

  16 weeks

Study Arms (4)

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; Dietary Supplement: Nepro; Dietary Supplement: anti-inflammatory module (similar to Oxepa)

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; Dietary Supplement: anti-inflammatory module (similar to Oxepa); Drug: Placebo pill imitating pentoxiphylline

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; Dietary Supplement: Placebo to imitate Nepro; Dietary Supplement: Placebo to imitate anti-inflammatory module (similar to Oxepa)

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; Dietary Supplement: Placebo to imitate Nepro; Dietary Supplement: Placebo to imitate anti-inflammatory module (similar to Oxepa)

Interventions

pentoxiphylline DRUG

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)

Also known as: Trental, 400 mg pills

A; C

Nepro DIETARY_SUPPLEMENT

Nepro (8 ounces) one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

Also known as: Nepro with Carb ™ Steady

A; B

anti-inflammatory module (similar to Oxepa) DIETARY_SUPPLEMENT

Oxepa-similar anti-inflammatory module (2 ounces) while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)

Also known as: Oxepa-similar anti-inflammatory module (2 ounces)

A; B

Placebo pill imitating pentoxiphylline DRUG

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)

Also known as: 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)

B; D

Placebo to imitate Nepro DIETARY_SUPPLEMENT

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)

Also known as: Placebo to imitate Nepro (8 ounces), with less protein and calorie,

C; D

Placebo to imitate anti-inflammatory module (similar to Oxepa) DIETARY_SUPPLEMENT

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)

Also known as: Placebo to immitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingredients,, 0011084880

C; D

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• DaVita, Inc.: collaborator
• Abbott Nutrition: collaborator

Study Sites (2)

DaVita Nutrition Services

Irvine, California, 92618, United States

Location

Los Angeles Biomedical Research Institute (LABioMed) at Harbor-UCLA

Torrance, California, 90502, United States

Location

Related Publications (12)

• 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. doi: 10.1016/j.jrn.2005.04.004.

  PMID: 16007562 BACKGROUND

• 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. doi: 10.1053/j.jrn.2005.01.003.

  PMID: 15827897 BACKGROUND

• 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. doi: 10.1097/01.asn.0000131523.17045.56.

  PMID: 15213276 BACKGROUND

• 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. doi: 10.1093/ndt/gfh941. Epub 2005 Jun 14.

  PMID: 15956056 BACKGROUND

• 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. doi: 10.1093/ajcn/80.2.299.

  PMID: 15277149 BACKGROUND

• 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. doi: 10.1016/j.ajkd.2003.07.016.

  PMID: 14582032 BACKGROUND

• 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. doi: 10.1016/j.jrn.2004.10.006.

  PMID: 16007564 BACKGROUND

• Kalantar-Zadeh K, Balakrishnan VS. The kidney disease wasting: inflammation, oxidative stress, and diet-gene interaction. Hemodial Int. 2006 Oct;10(4):315-25. doi: 10.1111/j.1542-4758.2006.00124.x.

  PMID: 17014506 BACKGROUND

• 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. doi: 10.1111/j.1525-139X.2005.00074.x.

  PMID: 16191172 BACKGROUND

• 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. doi: 10.1097/01.mco.0000172578.56396.9e.

  PMID: 15930963 BACKGROUND

• Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

  PMID: 37916745 DERIVED

• Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.

  PMID: 32390133 DERIVED

MeSH Terms

Conditions

Hypoalbuminemia; Protein-Energy Malnutrition; Inflammation; Renal Insufficiency, Chronic

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kamyar Kalantar-Zadeh, MD MPH PhD

  LABioMed at Harbor-UCLA

  PRINCIPAL INVESTIGATOR

• Arezu Dezfuli, MD

  LABioMed at Harbor-UCLA

  STUDY DIRECTOR

• Jennie Jing, MS

  LABioMed at Harbor-UCLA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 20, 2007
• Study Start: February 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: May 1, 2011
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

US (2)