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Trial record 12 of 22 for:    Viusid

Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Catalysis SL

Tracking Information
First Submitted Date  ICMJE September 15, 2009
First Posted Date  ICMJE September 16, 2009
Last Update Posted Date July 7, 2010
Study Start Date  ICMJE October 2009
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Inflammatory Syndrome
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: September 15, 2009)
152
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2011
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cuba
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00978224
Other Study ID Numbers  ICMJE CAT-0907-CU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mirna Atiés Sánchez, Institute of Nephrology
Study Sponsor  ICMJE Catalysis SL
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mirna Atiés Sánchez, MD Institute of Nephrology "Dr. Abelardo Buch López"
PRS Account Catalysis SL
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP