Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01031966

A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine

END STAGE RENAL DISEASE Clinical Trial

Official title:
A Pilot, Randomized, Open-label Study in Patients on Chronic Dialysis With End Stage Renal Disease (Esrd), to Evaluate the Enhancing Effect of Two Doses of Thymosin Alpha 1 on the Immunogenicity of h1n1sw Monovalent Vaccine

Clinical Trial Summary

The purpose of this explorative trial is to collect preliminary data on efficacy and safety of thymosin alpha 1 given at different doses as an adjuvant to egg-derived H1N1sw monovalent influenza vaccine in hemodialysis patients. The final aim is that of gathering information needed for planning a following confirmatory study on the efficacy and safety of Thymosin alpha 1 in the same indication.

Clinical Trial Description

The emergence and spread of the novel influenza A (H1N1) virus has been of great concern globally.

Uremic patients are especially vulnerable to infections and it is generally recommended to vaccinate patients with chronic renal insufficiency yearly against influenza. In patients on haemodialysis (HD) the vaccination response has been considered suboptimal.

Decreased antibody response to T-cell dependent antigens may be one factor that accounts for insufficient efficacy of certain vaccination programs (eg, influenza). Diminished antibody responses have also been reported in patients with end-stage renal disease. The evidence for impairment of cell-mediated immunity in hemodialysis patients has been attributed to incompetence in T-cell-mediated immune responses.

Since Zadaxin can enhance T-cell-dependent specific antibody production, the addition of Zadaxin (Thymosin alpha 1)to vaccination programs for immunocompromised individuals should be effective. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01031966
Study type Interventional
Source sigma-tau i.f.r. S.p.A.
Contact
Status Completed
Phase Phase 2
Start date November 2009
Completion date July 2010
View Details
See also
  Status Clinical Trial Phase
Completed NCT04076488 - Feasibility of an Interactive Tablet-based Exercise Program for People With Chronical Diseases N/A
Completed NCT03289650 - Extended Release Tacrolimus vs. Twice-Daily Tacrolimus Phase 3
Completed NCT04042324 - A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients Phase 1/Phase 2
Completed NCT01242904 - Use of a Bimodal Solution for Peritoneal Dialysis Phase 2
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT03257410 - Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients N/A
Completed NCT03627299 - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors Phase 4
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Terminated NCT03539861 - Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients N/A
Withdrawn NCT02130817 - Belatacept in Kidney Transplantation of Moderately Sensitized Patients Phase 4
Completed NCT05540457 - Evaluation of Non-Invasive Continuous vs Intermittent BloodPressure Monitors in Maintenance Dialysis (BP Dialysis) N/A
Not yet recruiting NCT04900610 - The Effect of Vitamin K2 Supplementation on Arterial Stifness and Cardiovascular Events in PEritonial DIAlysis N/A
Recruiting NCT02176434 - Pilot Feasibility Study of Combined Kidney and Hematopoietic Stem Cell Transplantation to Cure End-stage Renal Disease N/A
Active, not recruiting NCT02581449 - Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis Phase 2
Completed NCT02830490 - Reliability of Functional Measures in Hemodialysis Patient. N/A
Completed NCT02134314 - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI Phase 1/Phase 2
Completed NCT02832466 - Quantifying the Deterioration of Physical Function in Renal Patients N/A
Completed NCT02215655 - Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence N/A
Completed NCT02832440 - Comparison of Two Exercise Programmes in Patients Undergoing Hemodialysis N/A
Recruiting NCT01912001 - Virtual Ward for Home Dialysis N/A