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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Trial recruitment is currently suspended

Enrollment

152

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Oct 2009

Geographic Reach

1 country

1 active site

Status

suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

September 15, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed

15 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed

Last Updated

July 7, 2010

Status Verified

July 1, 2010

Enrollment Period

1.9 years

First QC Date

September 15, 2009

Last Update Submit

July 6, 2010

Conditions

Chronic Inflammatory Syndrome

Keywords

dietary supplementhemodialysisChronic Inflammatory SyndromeViusid

Outcome Measures

Primary Outcomes (4)

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 Outcomes (14)

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
+9 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

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

Dietary Supplement: Viusid

B

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

ViusidDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

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

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects with chronic terminal nephropathy under hemodialysis treatment for at least 3 months
Signed informed consent

You may not qualify if:

Patients with chronic terminal nephropathy previously treated with peritoneal dialysis
Receptors of a renal graft
Patients with malignant neoplastic conditions
Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Catalysis SLlead

Study Sites (1)

Institute of Nephrology "Dr. Abelardo Buch López"

Havana, 10400, Cuba

Location

MeSH Terms

Interventions

Viusid

Study Officials

Mirna Atiés Sánchez, MD
Institute of Nephrology "Dr. Abelardo Buch López"
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 16, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

CU(1)

Study Stopped

Viusid Administration in Subjects With Chronic Inflammatory Syndrome Under Hemodialysis Treatment

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (14)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (14)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

Locations