Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

This study has suspended participant recruitment.
(Decision of the investigator)
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00978224
First received: September 15, 2009
Last updated: July 6, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Chronic Inflammatory Syndrome
Dietary Supplement: Viusid
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • Body mass index (BMI) at week 72 (end of the treatment) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Carotidal Doppler at week 72 (end of the treatment) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • C reactive protein at weeks 72 (end of the treatment) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Hemoglobin at week 72 (end of the treatment) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cholesterol at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Triglycerides at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Frequency of infection episodes at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Creatinine at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Uric acid at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Glutamic-pyruvic transaminase (GPT)at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Glutamic-oxaloacetic transaminase (GOT)at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Blood glucose concentrations at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Gasometry at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Adverse effects at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]
  • Albumin at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • KTV at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Phosphocalcic metabolism at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Hematocrit at week 72 [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 152
Study Start Date: October 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mirna Atiés Sánchez, Institute of Nephrology
ClinicalTrials.gov Identifier: NCT00978224     History of Changes
Other Study ID Numbers: CAT-0907-CU
Study First Received: September 15, 2009
Last Updated: July 6, 2010
Health Authority: Cuba: Institutional Review Board

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

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014