Chronic Inflammatory Syndrome Clinical Trial
Official title:
Efficacy of Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment
| Verified date | July 2010 |
| Source | Catalysis SL |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Cuba: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Suspended |
| Enrollment | 152 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Cuba | Institute of Nephrology "Dr. Abelardo Buch López" | Havana |
| Lead Sponsor | Collaborator |
|---|---|
| Catalysis SL |
Cuba,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Body mass index (BMI) at week 72 (end of the treatment) | 72 weeks | No | |
| Primary | Carotidal Doppler at week 72 (end of the treatment) | 72 weeks | No | |
| Primary | C reactive protein at weeks 72 (end of the treatment) | 72 weeks | No | |
| Primary | Hemoglobin at week 72 (end of the treatment) | 72 weeks | No | |
| Secondary | Cholesterol at week 72 | 72 weeks | No | |
| Secondary | Triglycerides at week 72 | 72 weeks | No | |
| Secondary | Frequency of infection episodes at week 72 | 72 weeks | No | |
| Secondary | Creatinine at week 72 | 72 weeks | No | |
| Secondary | Uric acid at week 72 | 72 weeks | No | |
| Secondary | Glutamic-pyruvic transaminase (GPT)at week 72 | 72 weeks | No | |
| Secondary | Glutamic-oxaloacetic transaminase (GOT)at week 72 | 72 weeks | No | |
| Secondary | Blood glucose concentrations at week 72 | 72 weeks | No | |
| Secondary | Gasometry at week 72 | 72 weeks | No | |
| Secondary | Adverse effects at week 72 | 72 weeks | Yes | |
| Secondary | Albumin at week 72 | 72 weeks | No | |
| Secondary | KTV at week 72 | 72 weeks | No | |
| Secondary | Phosphocalcic metabolism at week 72 | 72 weeks | No | |
| Secondary | Hematocrit at week 72 | 72 weeks | No |