Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

Catalysis SL

Status and phase: Suspended; Phase 3

Conditions: Chronic Inflammatory Syndrome

Treatments: Dietary Supplement: Viusid; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00978224

CAT-0907-CU

Details and patient eligibility

About

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.

Enrollment: 152 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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152 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Viusid in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet

Treatment:

Dietary Supplement: Viusid

B

Placebo Comparator group

Description:

Placebo in combination with standard treatment for Chronic Inflammatory Syndrome including hemodialysis and the administration of a hypercaloric and hyperproteic diet

Treatment:

Dietary Supplement: Placebo