Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

NCT ID: NCT00978224

Last Updated: 2010-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Chronic Inflammatory Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

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

Group Type EXPERIMENTAL

Viusid

Intervention Type DIETARY_SUPPLEMENT

3 Viusid bags (Orally administered) per day, for 60 weeks

B

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

3 Placebo bags (Orally administered) per day, for 60 weeks.

Interventions

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Viusid

3 Viusid bags (Orally administered) per day, for 60 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

3 Placebo bags (Orally administered) per day, for 60 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Catalysis SL

INDUSTRY

Sponsor Role lead

Responsible Party

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Institute of Nephrology

Principal Investigators

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Mirna Atiés Sánchez, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Nephrology "Dr. Abelardo Buch López"

Locations

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Institute of Nephrology "Dr. Abelardo Buch López"

Havana, , Cuba

Site Status

Countries

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Cuba

Other Identifiers

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CAT-0907-CU

Identifier Type: -

Identifier Source: org_study_id

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