Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

• ClinicalTrials.gov Identifier: NCT00978224
• Recruitment Status: Suspended
• First Posted: September 16, 2009
• Last Update Posted: July 7, 2010
• Sponsor: Catalysis SL
• Information provided by: Catalysis SL

Tracking Information

• First Submitted Date: September 15, 2009
• First Posted Date: September 16, 2009
• Last Update Posted Date: July 7, 2010
• Study Start Date: October 2009
• Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 15, 2009)

• Body mass index (BMI) at week 72 (end of the treatment) [ Time Frame: 72 weeks ]
• Carotidal Doppler at week 72 (end of the treatment) [ Time Frame: 72 weeks ]
• C reactive protein at weeks 72 (end of the treatment) [ Time Frame: 72 weeks ]
• Hemoglobin at week 72 (end of the treatment) [ Time Frame: 72 weeks ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 15, 2009)

• Cholesterol at week 72 [ Time Frame: 72 weeks ]
• Triglycerides at week 72 [ Time Frame: 72 weeks ]
• Frequency of infection episodes at week 72 [ Time Frame: 72 weeks ]
• Creatinine at week 72 [ Time Frame: 72 weeks ]
• Uric acid at week 72 [ Time Frame: 72 weeks ]
• Glutamic-pyruvic transaminase (GPT)at week 72 [ Time Frame: 72 weeks ]
• Glutamic-oxaloacetic transaminase (GOT)at week 72 [ Time Frame: 72 weeks ]
• Blood glucose concentrations at week 72 [ Time Frame: 72 weeks ]
• Gasometry at week 72 [ Time Frame: 72 weeks ]
• Adverse effects at week 72 [ Time Frame: 72 weeks ]
• Albumin at week 72 [ Time Frame: 72 weeks ]
• KTV at week 72 [ Time Frame: 72 weeks ]
• Phosphocalcic metabolism at week 72 [ Time Frame: 72 weeks ]
• Hematocrit at week 72 [ Time Frame: 72 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
• Official Title: Efficacy of Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Chronic Inflammatory Syndrome

Intervention

• Dietary Supplement: Viusid
  3 Viusid bags (Orally administered) per day, for 60 weeks
• Dietary Supplement: Placebo
  3 Placebo bags (Orally administered) per day, for 60 weeks.

Study Arms

• Experimental: A
  Viusid in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet
  Intervention: Dietary Supplement: Viusid
• Placebo Comparator: B
  Placebo in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet
  Intervention: Dietary Supplement: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: September 15, 2009): 152
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2011
• Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Cuba

Administrative Information

• NCT Number: NCT00978224
• Other Study ID Numbers: CAT-0907-CU
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mirna Atiés Sánchez, Institute of Nephrology
• Study Sponsor: Catalysis SL
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mirna Atiés Sánchez, MD; Institute of Nephrology "Dr. Abelardo Buch López"

• PRS Account: Catalysis SL
• Verification Date: July 2010