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HypoalbuminemiaPhase 3AIONIDNCT00561093

Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients

A Phase 3 study testing pentoxiphylline, Nepro and anti-inflammatory module (similar to Oxepa) in people with Hypoalbuminemia and Protein-energy Malnutrition, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
pentoxiphylline, Nepro and anti-inflammatory module (similar to Oxepa)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
2 sitesUnited States
Study dates
Feb 2008to May 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • DaVita Nutrition Services

    Irvine, California, 92618

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

    Torrance, California, 90502

Other trials in United States

About this 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

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

Read the 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

Being tested
pentoxiphylline, Nepro, anti-inflammatory module (similar to Oxepa), Placebo pill imitating pentoxiphylline, Placebo to imitate Nepro
Keywords
Hypoalbuminemia, Protein-energy malnutrition, Inflammation, Oxidative stress, Chronic Kidney disease (CKD) stage 5, maintenance hemodialysis
Medical subject headings
Hypoalbuminemia, Protein-Energy Malnutrition, Inflammation, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pentoxiphyllineDrug

    Also called Trental, 400 mg pills

    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)

  • NeproDietary supplement

    Also called Nepro with Carb ™ Steady

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

  • anti-inflammatory module (similar to Oxepa)Dietary supplement

    Also called Oxepa-similar anti-inflammatory module (2 ounces)

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

  • Placebo pill imitating pentoxiphyllineDrug

    Also called 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)

    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)

  • Placebo to imitate NeproDietary supplement

    Also called Placebo to imitate Nepro (8 ounces), with less protein and calorie,

    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)

  • Placebo to imitate anti-inflammatory module (similar to Oxepa)Dietary supplement

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

    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)

Study groups in NCT00561093
Study groupRoleWhat they receive
AExperimentalGroup 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)
Receives: Drug: pentoxiphylline; Dietary Supplement: Nepro; Dietary Supplement: anti-inflammatory module (similar to Oxepa)
BExperimentalGroup 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)
Receives: Dietary Supplement: Nepro; Dietary Supplement: anti-inflammatory module (similar to Oxepa); Drug: Placebo pill imitating pentoxiphylline
CExperimentalGroup 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)
Receives: Drug: pentoxiphylline; Dietary Supplement: Placebo to imitate Nepro; Dietary Supplement: Placebo to imitate anti-inflammatory module (similar to Oxepa)
DPlacebo comparatorGroup 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)
Receives: Drug: Placebo pill imitating pentoxiphylline; Dietary Supplement: Placebo to imitate Nepro; Dietary Supplement: Placebo to imitate anti-inflammatory module (similar to Oxepa)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum albumin

    Measured: 16 weeks

Secondary outcomes (1)

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

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2007 (estimated)
  2. Study startFeb 2008
  3. Primary completionOct 2010
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00561093
Sponsor's protocol ID
R21 DK78012 (completed)
Other IDs
Harbor-UCLA LABioMed # 12630, R21DK078012
Acronym
AIONID
Status last verified
May 2015
First submitted
19 Nov 2007
Last updated
21 May 2015
Results posted
No
Data monitoring committee
Yes

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. doi: 10.1016/j.jrn.2005.04.004.

    PubMed 16007562

  • 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.

    PubMed 15827897

  • 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.

    PubMed 15213276

  • 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.

    PubMed 15956056

  • 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.

    PubMed 15277149

  • 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.

    PubMed 14582032

  • 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.

    PubMed 16007564

  • 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.

    PubMed 17014506

  • 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.

    PubMed 16191172

  • 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.

    PubMed 15930963

  • 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.

    PubMed 37916745

  • 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.

    PubMed 32390133

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pentoxiphylline, Nepro and anti-inflammatory module (similar to Oxepa) in people with Hypoalbuminemia and Protein-energy Malnutrition, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum albumin (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00561093, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.

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