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Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

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ClinicalTrials.gov Identifier: NCT00978224
Recruitment Status : Suspended (Decision of the investigator)
First Posted : September 16, 2009
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of the study is to determine whether Viusid administration improves malnutrition, atherosclerosis, erythropoietin response and the frequency of infection episodes in subjects with Chronic Inflammatory Syndrome under hemodialysis treatment. The duration of this double-blind placebo controlled phase 3 clinical trial will be 60 weeks. All patients enrolled in the study will be receiving the standard treatment for Chronic Inflammatory Syndrome including hemodialysis and administration of a hypercaloric and hyperproteic diet. Efficacy assessment will be carried out 12 weeks after the end of Viusid or placebo treatment.

Condition or disease Intervention/treatment Phase
Chronic Inflammatory Syndrome Dietary Supplement: Viusid Dietary Supplement: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
Study Start Date : October 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
Viusid in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet
Dietary Supplement: Viusid
3 Viusid bags (Orally administered) per day, for 60 weeks
Placebo Comparator: B
Placebo in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet
Dietary Supplement: Placebo
3 Placebo bags (Orally administered) per day, for 60 weeks.


Outcome Measures

Primary Outcome Measures :
  1. Body mass index (BMI) at week 72 (end of the treatment) [ Time Frame: 72 weeks ]
  2. Carotidal Doppler at week 72 (end of the treatment) [ Time Frame: 72 weeks ]
  3. C reactive protein at weeks 72 (end of the treatment) [ Time Frame: 72 weeks ]
  4. Hemoglobin at week 72 (end of the treatment) [ Time Frame: 72 weeks ]

Secondary Outcome Measures :
  1. Cholesterol at week 72 [ Time Frame: 72 weeks ]
  2. Triglycerides at week 72 [ Time Frame: 72 weeks ]
  3. Frequency of infection episodes at week 72 [ Time Frame: 72 weeks ]
  4. Creatinine at week 72 [ Time Frame: 72 weeks ]
  5. Uric acid at week 72 [ Time Frame: 72 weeks ]
  6. Glutamic-pyruvic transaminase (GPT)at week 72 [ Time Frame: 72 weeks ]
  7. Glutamic-oxaloacetic transaminase (GOT)at week 72 [ Time Frame: 72 weeks ]
  8. Blood glucose concentrations at week 72 [ Time Frame: 72 weeks ]
  9. Gasometry at week 72 [ Time Frame: 72 weeks ]
  10. Adverse effects at week 72 [ Time Frame: 72 weeks ]
  11. Albumin at week 72 [ Time Frame: 72 weeks ]
  12. KTV at week 72 [ Time Frame: 72 weeks ]
  13. Phosphocalcic metabolism at week 72 [ Time Frame: 72 weeks ]
  14. Hematocrit at week 72 [ Time Frame: 72 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with chronic terminal nephropathy under hemodialysis treatment for at least 3 months
  • Signed informed consent

Exclusion Criteria:

  • Patients with chronic terminal nephropathy previously treated with peritoneal dialysis
  • Receptors of a renal graft
  • Patients with malignant neoplastic conditions
  • Pregnant women
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978224


Locations
Cuba
Institute of Nephrology "Dr. Abelardo Buch López"
Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Mirna Atiés Sánchez, MD Institute of Nephrology "Dr. Abelardo Buch López"
More Information

Responsible Party: Mirna Atiés Sánchez, Institute of Nephrology
ClinicalTrials.gov Identifier: NCT00978224     History of Changes
Other Study ID Numbers: CAT-0907-CU
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Catalysis SL:
dietary supplement
hemodialysis
Chronic Inflammatory Syndrome
Viusid

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes