| |
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
Hypoalbuminemia
Protein-Energy Malnutrition
Inflammation
Oxidative Stress
Chronic Kidney Disease (CKD) Stage 5 Undergoing Maintenance Hemodialysis
|
Drug: pentoxiphylline
Dietary Supplement: Nepro
Dietary Supplement: anti-inflammatory module (similar to Oxepa)
Drug: Placebo pill immitating pentoxiphylline
Dietary Supplement: Placebo to immitate Nepro
Dietary Supplement: Placebo to immitate anti-inflammatory module (similar to Oxepa)
|
Phase III
|
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 |
Primary Outcome Measures:
- Change in serum albumin [ Time Frame: 16 weeks ]
Secondary Outcome Measures:
- Changes in body composition and measures of nutrition, inflammation, anemia and Health related quality of life (HRQOL) [ Time Frame: 16 weeks ]
| Estimated Enrollment: |
100 |
| Study Start Date: |
December 2007 |
| Estimated Study Completion Date: |
November 2009 |
| A: Experimental
Group A (n=25) Nepro (8 ounces) and Oxepa-similar anti-inflammatory module (2 ouces) 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 ouces) AND Placebo to immitate pentoxiphylline while undergoin 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 immitating pentoxiphylline
Placebo pill immitating pentoxiphylline 400 mg daily, to immitate 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 immitate Nepro (8 ounces) and Oxepa-similar anti-inflammatory module (2 ouces) 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 immitate Nepro
Placebo to immitate Nepro (8 ounces), with less protien and calorie, one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week) Dietary Supplement: Placebo to immitate anti-inflammatory module (similar to Oxepa)
Placebo to immitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingradients, 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 immitate Nepro (8 ounces) and Oxepa-similar anti-inflammatory module (2 ouces) AND Placebo to immitate pentoxiphylline (400 mg) while undergoing hemodialysis and the following non-dialysis day (6 days per week) |
Drug: Placebo pill immitating pentoxiphylline
Placebo pill immitating pentoxiphylline 400 mg daily, to immitate 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 immitate Nepro
Placebo to immitate Nepro (8 ounces), with less protien and calorie, one can while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week) Dietary Supplement: Placebo to immitate anti-inflammatory module (similar to Oxepa)
Placebo to immitate Oxepa-similar anti-inflammatory module (2 ounces), without anti-inflammatory or anti-oxidative ingradients, while undergoing thrice weekly hemodialysis and during the following non-dialysis day (6 days per week) |
 |
| Ages Eligible for Study: |
18 Years to 80 Years |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
Inclusion Criteria:
- At least 6 months on maintenance hemodialysis,
- Last 3-month averaged serum albumin <4.0 g/dl,
- Average monthly Kt/V>1.4,
- Dialysis time between 3.5 and 5 hours,
- Functioning AV graft or fistula,
- Standardized dialysis treatment per DaVita Wild West 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 6 months
- Concurrent appetite stimulants
- Use of IDPN in the past 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561093
|
|
| Los Angeles Biomedical Research Institute (LABioMed) at Harbor-UCLA |
|
|
| Torrance, California, United States, 90502 |
|
| Contact: Vanessa Saldivar 310-222-2346 vsaldivar@labiomed.org |
|
| Contact: Brenda Martinez 310-222-2346 bmartinez@labiomed.org |
|
| 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 |
|
|
| Los Angeles Biomedical Research Institute (LABioMed) at Harbor-UCLA |
|
|
| Torrance, California, United States, 90502 |
|
| Contact: Vanessa Saldivar 310-222-2346 vsaldivar@labiomed.org |
|
| Contact: Brenda Martinez 310-222-2346 bmartinez@labiomed.org |
|
| 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 |
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.
|
| Study ID Numbers: |
DK78012, Harbo-UCLA LABioMed # 12630 |
| First Received: |
November 19, 2007 |
| Last Updated: |
November 19, 2007 |
| 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 |
| Kidney Failure, Chronic |
| Cachexia |
| Stress |
| Protein-Energy Malnutrition |
| Pentoxifylline |
| Bismuth subsalicylate |
| Inflammation |
| Attapulgite | |
|
| Malnutrition |
| Protein Deficiency |
| Urologic Diseases |
| Renal Insufficiency, Chronic |
| Hypoalbuminemia |
| Nutrition Disorders |
| Kidney Diseases |
| Deficiency Diseases |
| Kidney Failure | | Additional relevant MeSH terms:
| Hypoproteinemia |
| Hypoalbuminemia |
| Pathologic Processes |
| Blood Protein Disorders | |
|
|
