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Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients (AIONID)

Primary Purpose

Hypoalbuminemia, Protein-energy Malnutrition, Inflammation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
pentoxiphylline
Nepro
anti-inflammatory module (similar to Oxepa)
Placebo pill imitating pentoxiphylline
Placebo to imitate Nepro
Placebo to imitate anti-inflammatory module (similar to Oxepa)
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoalbuminemia focused on measuring Hypoalbuminemia, Protein-energy malnutrition, Inflammation, Oxidative stress, Chronic Kidney disease (CKD) stage 5, maintenance hemodialysis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • DaVita Nutrition Services
  • Los Angeles Biomedical Research Institute (LABioMed) at Harbor-UCLA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

D

Arm Description

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)

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)

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)

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)

Outcomes

Primary Outcome Measures

Change in serum albumin

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2007
Last Updated
May 20, 2015
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
DaVita Dialysis, Abbott Nutrition
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1. Study Identification

Unique Protocol Identification Number
NCT00561093
Brief Title
Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients
Acronym
AIONID
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
DaVita Dialysis, Abbott Nutrition

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
There are 350,000 hemodialysis patients in the USA; these are people who have end-stage kiney disease and whose survival depends on thrice weekly hemodialysis treatment in a dialysis clinic. Hemodialysis patients have an unacceptably high death rate, so that one out of every 4 to 5 patients die each year. Almost half of all deaths are believed to be from heart disease. Because markers of malnutrition and inflammation such as low amount of blood protein (serum albumin <4.0 g/dL), rather than traditional risk factors, are among the strongest predictors of early death and because malnutrition-inflammation appears to be closely related to oxidative stress in hemodialysis patients, we would like to examine that hypotesis that treating malnutrition-inflammation-oxidation by mean of nutritional support may improve outcomes in them. Low serum albumin <4.0 g/dL is observed in almost half of all hemodialysis patients and appears associated with low appetite, wasting, inflammation, malfunction of the vessels, cardiovascular disease and several fold increase in mortality. We hypothesize that the malnutrition-inflammation can be significantly corrected by a simple in-center oral nutritional support with anti-inflammatory and antioxidant properties combined with an appetite stimulant with anti-inflammatory properties, leading to improved clinical and nutritional outcome measures in hemodialysis patients. We have proposed to the National Institutes of Health a pilot/feasibility study where dialysis patients will have 50-50 chance of receiving real treatment or a fake version of it (placebo). This method is called randomization, and this study type is called "randomized placebo-controlled clinical trial" with two arms, a so-called 2x2 factorial design. Our proposed study has a low-priced but efficient operational system and will be performed in 8 to 10 DaVita dialysis clinics in Los Angles area. During this 2-year pilot/feasibility study, we will test whether our proposed nutritional and anti-inflammatory treatments are safe and can improve low serum albumin and other relevant outcomes in 100 hemodialysis patients. Subjects will be adult hemodialysis patients with a serum albumin <4.0 g/dL. The nutritional support arm will include a combination of 2 oral nutritional supplements; i.e., Nepro™ (8 oz), tailored for malnourished hemodialysis patients; and a condensed anti-inflammatory module similar to Oxepa™ (2 oz), designed for sick patients with inflammation and oxidative stress; or their placebos. The appetite stimulating arm will include a medication known as "pentoxifylline" (also known as Trental™) and the dose will be 400 mg daily or its placebo. If a patient qualifies and agrees to participate in the study, there will be one month of observations and tests, followed by 16 weeks of treatment, and then one additional month of observation at the end. Both interventions are administered thrice weekly during routine hemodialysis for 16 weeks. Nutritional, inflammatory and oxidative measures, vessel wall (endothelial) function, quality of life and other clinical measures will be obtained before, during, and after the intervention. The safety and tolerability of the treatments, the feasibility of the study design, and the measurability of the outcomes will be examined. We hope that the successful completion of this pilot/feasibility study in our campus leads to design of a large-scale clinical trial at the national level to improve survival in dialysis patients using nutritional and anti-inflammatory treatments. Figure 1. Proposed pilot/feasibility study (see Appendix 1 for color version) Group A (n=25) Nepro/Oxepa (2 cans) + PTX (400 mg) while on HD & the following day Group B (n=25) Nepro/Oxepa (2 CANS) + placebo PTX while on HD& the following day Group C (n=25) Placebo 2 cans + PTX (400 mg) while on HD& the following day Group D (n=25) Placebo 2 cans + placebo PTX while on HD& the following day PTX: pentoxifylline HD: Hemodialysis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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)
Arm Title
B
Arm Type
Experimental
Arm Description
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)
Arm Title
C
Arm Type
Experimental
Arm Description
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)
Arm Title
D
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
pentoxiphylline
Other Intervention Name(s)
Trental, 400 mg pills
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Nepro
Other Intervention Name(s)
Nepro with Carb ™ Steady
Intervention Description
Nepro (8 ounces) one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
Intervention Type
Dietary Supplement
Intervention Name(s)
anti-inflammatory module (similar to Oxepa)
Other Intervention Name(s)
Oxepa-similar anti-inflammatory module (2 ounces)
Intervention Description
Oxepa-similar anti-inflammatory module (2 ounces) while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week)
Intervention Type
Drug
Intervention Name(s)
Placebo pill imitating pentoxiphylline
Other Intervention Name(s)
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)
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo to imitate Nepro
Other Intervention Name(s)
Placebo to imitate Nepro (8 ounces), with less protein and calorie,
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo to imitate anti-inflammatory module (similar to Oxepa)
Other Intervention Name(s)
Placebo to immitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingredients,, 0011084880
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in serum albumin
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Changes in body composition and measures of nutrition, inflammation, anemia, Health related quality of life (HRQOL), and tolerance
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamyar Kalantar-Zadeh, MD MPH PhD
Organizational Affiliation
LABioMed at Harbor-UCLA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arezu Dezfuli, MD
Organizational Affiliation
LABioMed at Harbor-UCLA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jennie Jing, MS
Organizational Affiliation
LABioMed at Harbor-UCLA
Official's Role
Study Director
Facility Information:
Facility Name
DaVita Nutrition Services
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Los Angeles Biomedical Research Institute (LABioMed) at Harbor-UCLA
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16007562
Citation
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.
Results Reference
background
PubMed Identifier
15827897
Citation
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.
Results Reference
background
PubMed Identifier
15213276
Citation
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.
Results Reference
background
PubMed Identifier
15956056
Citation
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.
Results Reference
background
PubMed Identifier
15277149
Citation
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.
Results Reference
background
PubMed Identifier
14582032
Citation
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.
Results Reference
background
PubMed Identifier
16007564
Citation
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.
Results Reference
background
PubMed Identifier
17014506
Citation
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.
Results Reference
background
PubMed Identifier
16191172
Citation
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.
Results Reference
background
PubMed Identifier
15930963
Citation
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.
Results Reference
background
PubMed Identifier
32390133
Citation
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.
Results Reference
derived

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Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients

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