Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
Primary Purpose
Chronic Inflammatory Syndrome
Status
Suspended
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
Viusid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Inflammatory Syndrome focused on measuring dietary supplement, hemodialysis, Chronic Inflammatory Syndrome, Viusid
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
Sites / Locations
- Institute of Nephrology "Dr. Abelardo Buch López"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Viusid in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet
Placebo in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet
Outcomes
Primary Outcome Measures
Body mass index (BMI) at week 72 (end of the treatment)
Carotidal Doppler at week 72 (end of the treatment)
C reactive protein at weeks 72 (end of the treatment)
Hemoglobin at week 72 (end of the treatment)
Secondary Outcome Measures
Cholesterol at week 72
Triglycerides at week 72
Frequency of infection episodes at week 72
Creatinine at week 72
Uric acid at week 72
Glutamic-pyruvic transaminase (GPT)at week 72
Glutamic-oxaloacetic transaminase (GOT)at week 72
Blood glucose concentrations at week 72
Gasometry at week 72
Adverse effects at week 72
Albumin at week 72
KTV at week 72
Phosphocalcic metabolism at week 72
Hematocrit at week 72
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00978224
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Suspended
Why Stopped
Decision of the investigator
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Catalysis SL
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Syndrome
Keywords
dietary supplement, hemodialysis, Chronic Inflammatory Syndrome, Viusid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Viusid in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Viusid
Intervention Description
3 Viusid bags (Orally administered) per day, for 60 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
3 Placebo bags (Orally administered) per day, for 60 weeks.
Primary Outcome Measure Information:
Title
Body mass index (BMI) at week 72 (end of the treatment)
Time Frame
72 weeks
Title
Carotidal Doppler at week 72 (end of the treatment)
Time Frame
72 weeks
Title
C reactive protein at weeks 72 (end of the treatment)
Time Frame
72 weeks
Title
Hemoglobin at week 72 (end of the treatment)
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Cholesterol at week 72
Time Frame
72 weeks
Title
Triglycerides at week 72
Time Frame
72 weeks
Title
Frequency of infection episodes at week 72
Time Frame
72 weeks
Title
Creatinine at week 72
Time Frame
72 weeks
Title
Uric acid at week 72
Time Frame
72 weeks
Title
Glutamic-pyruvic transaminase (GPT)at week 72
Time Frame
72 weeks
Title
Glutamic-oxaloacetic transaminase (GOT)at week 72
Time Frame
72 weeks
Title
Blood glucose concentrations at week 72
Time Frame
72 weeks
Title
Gasometry at week 72
Time Frame
72 weeks
Title
Adverse effects at week 72
Time Frame
72 weeks
Title
Albumin at week 72
Time Frame
72 weeks
Title
KTV at week 72
Time Frame
72 weeks
Title
Phosphocalcic metabolism at week 72
Time Frame
72 weeks
Title
Hematocrit at week 72
Time Frame
72 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirna Atiés Sánchez, MD
Organizational Affiliation
Institute of Nephrology "Dr. Abelardo Buch López"
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Nephrology "Dr. Abelardo Buch López"
City
Havana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
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Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
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