Chronic Inflammatory SyndromePhase 3NCT00978224
Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
A Phase 3 study testing Viusid in people with Chronic Inflammatory Syndrome, run by Catalysis SL at 1 site in Cuba.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Inflammatory Syndrome
- What is being tested?
- Viusid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteCuba
- Study dates
- Oct 2009to Sep 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with chronic terminal nephropathy under hemodialysis treatment for at least 3 months
- Signed informed consent
Who cannot join
- Patients with chronic terminal nephropathy previously treated with peritoneal dialysis
- Receptors of a renal graft
- Patients with malignant neoplastic conditions
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
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.
- Conditions
- Chronic Inflammatory Syndrome
- Being tested
- Viusid, Placebo
- Keywords
- dietary supplement, hemodialysis, Chronic Inflammatory Syndrome, Viusid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViusidDietary supplement
3 Viusid bags (Orally administered) per day, for 60 weeks
PlaceboDietary supplement
3 Placebo bags (Orally administered) per day, for 60 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Viusid in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet Receives: Dietary Supplement: Viusid |
| B | Placebo comparator | Placebo in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI) at week 72 (end of the treatment)
Measured: 72 weeks
Carotidal Doppler at week 72 (end of the treatment)
Measured: 72 weeks
C reactive protein at weeks 72 (end of the treatment)
Measured: 72 weeks
Hemoglobin at week 72 (end of the treatment)
Measured: 72 weeks
Secondary outcomes (14)
Cholesterol at week 72
Measured: 72 weeks
Triglycerides at week 72
Measured: 72 weeks
Frequency of infection episodes at week 72
Measured: 72 weeks
Creatinine at week 72
Measured: 72 weeks
Uric acid at week 72
Measured: 72 weeks
Glutamic-pyruvic transaminase (GPT)at week 72
Measured: 72 weeks
Glutamic-oxaloacetic transaminase (GOT)at week 72
Measured: 72 weeks
Blood glucose concentrations at week 72
Measured: 72 weeks
Gasometry at week 72
Measured: 72 weeks
Adverse effects at week 72
Measured: 72 weeks
Albumin at week 72
Measured: 72 weeks
KTV at week 72
Measured: 72 weeks
Phosphocalcic metabolism at week 72
Measured: 72 weeks
Hematocrit at week 72
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: Decision of the investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mirna Atiés Sánchez, MD, Principal investigator, Institute of Nephrology "Dr. Abelardo Buch López"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978224
- Sponsor's protocol ID
- CAT-0907-CU
- Status last verified
- Jul 2010
- First submitted
- 15 Sep 2009
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
- ClinicalTrials.gov ID
- NCT00978224
- Acronym / sponsor ID
- CAT-0907-CU
- Conditions
- Chronic Inflammatory Syndrome
- Keywords
- dietary supplement, hemodialysis, Chronic Inflammatory Syndrome, Viusid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Decision of the investigator
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 16 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: ViusidViusid in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet |
| B | Placebo comparator | Dietary Supplement: PlaceboPlacebo in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with chronic terminal nephropathy under hemodialysis treatment for at least 3 months
- Signed informed consent
Key exclusion criteria (4 listed)
- Patients with chronic terminal nephropathy previously treated with peritoneal dialysis
- Receptors of a renal graft
- Patients with malignant neoplastic conditions
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viusid3 Viusid bags (Orally administered) per day, for 60 weeks | Dietary supplement | A |
| Placebo3 Placebo bags (Orally administered) per day, for 60 weeks. | Dietary supplement | B |
Primary outcome
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
14 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
Related trials for Chronic Inflammatory Syndrome
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirna Atiés Sánchez, MD principal investigator
Institute of Nephrology "Dr. Abelardo Buch López"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Viusid in people with Chronic Inflammatory Syndrome, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (BMI) at week 72 (end of the treatment) (time frame: 72 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.