Uremic Hyperhomocysteinemia -A Folate Trial for Possible Prevention of Cardiovascular Events

NCT00317005 | Completed Phase 4

• 1 other identifier: UEL/CPG/Nefro/Hcy
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 2

Brief Summary

Homocysteine recently gained access to the category of risk factor for the development of atherosclerotic cardiovascular disease in the general population. Chronic renal failure patients, even before being introduced to dialysis therapy have almost universal elevation of serum homocysteine; when on dialysis their mortality is above 50% related to cardiovascular disease that we might now speculate, with a contribution of potentially toxic levels of the aminoacid homocysteine.

Conditions

Uremia; Chronic Renal Failure; Hemodialysis; Hyperhomocysteinemia; Cardiovascular Disease

Keywords

hemodialysis; chronic uremia; hyperhomocysteinemia; folate

Outcome Measures

Primary Outcomes (2)

• Lowering of Homocysteine blood levels in uremia.

• Prevention of cardiovascular events

Secondary Outcomes (1)

• Reduction of carotid intima-media thickness

Interventions

folate treatment DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients stable on hemodialysis for 4 months or more
• Eighteen years of age or older

You may not qualify if:

• Potential kidney transplant from a living donor in the near future
• Severe cardiovascular disease
• Cancer and active inflammation

Sponsors & Collaborators

• Universidade Estadual de Londrina: lead

Study Sites (2)

Hospital Universitario regional do Note do Parana

Londrina, Paraná, 86020-320, Brazil

Location

University Hospital, State University of Londrina

Londrina, Paraná, 86020-320, Brazil

Location

Related Publications (1)

• Brenner RM, Wrone EM. The epidemic of cardiovascular disease in end-stage renal disease. Curr Opin Nephrol Hypertens. 1999 May;8(3):365-9. doi: 10.1097/00041552-199905000-00015. No abstract available.

  PMID: 10456270 BACKGROUND

MeSH Terms

Conditions

Uremia; Kidney Failure, Chronic; Hyperhomocysteinemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases; Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders

Study Officials

• Altair J Mocelin, MD PHD

  Nephrology, University Hospital, State University of Londrina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2006
• First Posted: April 21, 2006
• Study Start: April 1, 2003
• Study Completion: March 1, 2005
• Last Updated: July 26, 2018

Record last verified: 2005-05

Locations

BR (2)