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Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

Primary Purpose

Chronic Inflammatory Syndrome

Status

Suspended

Phase

Phase 3

Locations

Cuba

Study Type

Interventional

Intervention

Viusid

Placebo

About this trial

This is an interventional treatment trial for Chronic Inflammatory Syndrome focused on measuring dietary supplement, hemodialysis, Chronic Inflammatory Syndrome, Viusid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Institute of Nephrology "Dr. Abelardo Buch López"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Body mass index (BMI) at week 72 (end of the treatment)

Carotidal Doppler at week 72 (end of the treatment)

C reactive protein at weeks 72 (end of the treatment)

Hemoglobin at week 72 (end of the treatment)

Secondary Outcome Measures

Cholesterol at week 72

Triglycerides at week 72

Frequency of infection episodes at week 72

Creatinine at week 72

Uric acid at week 72

Glutamic-pyruvic transaminase (GPT)at week 72

Glutamic-oxaloacetic transaminase (GOT)at week 72

Blood glucose concentrations at week 72

Gasometry at week 72

Adverse effects at week 72

Albumin at week 72

KTV at week 72

Phosphocalcic metabolism at week 72

Hematocrit at week 72

Full Information

NCT ID

NCT00978224

First Posted

September 15, 2009

Last Updated

July 6, 2010

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT00978224

Brief Title

Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

Official Title

Efficacy of Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Suspended

Why Stopped

Decision of the investigator

Study Start Date

October 2009 (undefined)

Primary Completion Date

September 2011 (Anticipated)

Study Completion Date

September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Catalysis SL

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Inflammatory Syndrome

Keywords

dietary supplement, hemodialysis, Chronic Inflammatory Syndrome, Viusid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Viusid

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Body mass index (BMI) at week 72 (end of the treatment)

Time Frame

72 weeks

Title

Carotidal Doppler at week 72 (end of the treatment)

Time Frame

72 weeks

Title

C reactive protein at weeks 72 (end of the treatment)

Time Frame

72 weeks

Title

Hemoglobin at week 72 (end of the treatment)

Time Frame

72 weeks

Secondary Outcome Measure Information:

Title

Cholesterol at week 72

Time Frame

72 weeks

Title

Triglycerides at week 72

Time Frame

72 weeks

Title

Frequency of infection episodes at week 72

Time Frame

72 weeks

Title

Creatinine at week 72

Time Frame

72 weeks

Title

Uric acid at week 72

Time Frame

72 weeks

Title

Glutamic-pyruvic transaminase (GPT)at week 72

Time Frame

72 weeks

Title

Glutamic-oxaloacetic transaminase (GOT)at week 72

Time Frame

72 weeks

Title

Blood glucose concentrations at week 72

Time Frame

72 weeks

Title

Gasometry at week 72

Time Frame

72 weeks

Title

Adverse effects at week 72

Time Frame

72 weeks

Title

Albumin at week 72

Time Frame

72 weeks

Title

KTV at week 72

Time Frame

72 weeks

Title

Phosphocalcic metabolism at week 72

Time Frame

72 weeks

Title

Hematocrit at week 72

Time Frame

72 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mirna Atiés Sánchez, MD

Organizational Affiliation

Institute of Nephrology "Dr. Abelardo Buch López"

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Nephrology "Dr. Abelardo Buch López"

City

Havana

ZIP/Postal Code

10400

Country

Cuba

12. IPD Sharing Statement

Learn more about this trial

Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

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