Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

Phase 3

Suspended

• Conditions: Chronic Inflammatory Syndrome
• Interventions: Dietary Supplement: Viusid; Dietary Supplement: Placebo

• Registration Number: NCT00978224
• Lead Sponsor: Catalysis SL

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 available

Study Timeline

• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Study Start: 2009-10
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07
• Primary Completion: 2011-09
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Viusid	Viusid in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet
B	Placebo	Placebo in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet

Primary Outcome Measures

Name	Time	Method
Body mass index (BMI) at week 72 (end of the treatment)	72 weeks
Carotidal Doppler at week 72 (end of the treatment)	72 weeks
C reactive protein at weeks 72 (end of the treatment)	72 weeks
Hemoglobin at week 72 (end of the treatment)	72 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Nephrology "Dr. Abelardo Buch López"; 🇨🇺 Havana, Cuba