Effects of Mesna on Homocysteine in Kidney Failure

NCT00524199 | Completed Phase 2

• 2 other identifiers: R-06-472122006
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to examine the effect of a drug called mesna on the removal of homocysteine from blood during dialysis. Homocysteine is an amino acid (protein building block) found in the blood of all people, however it is considerably elevated in dialysis patients. People with increased levels of homocysteine in their blood are at increased risk of developing plaque buildup in their arteries and other related problems such as heart attack and stroke. This study will determine if mesna can improve the rate of homocysteine removal from blood during dialysis.

Conditions

End Stage Renal Disease

Keywords

homocysteine; hemodialysis; mesna

Outcome Measures

Primary Outcomes (1)

• Difference in plasma total homocysteine between placebo and mesna treatments

  Four weeks

Secondary Outcomes (1)

• Excretion of mesna during hemodialysis

  duration of dialytic session

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline IV infusion over five minutes at the beginning of dialysis.

Other: Saline

Mesna

ACTIVE COMPARATOR

12 mg/kg mesna IV infusion over five minutes at the beginning of dialysis.

Drug: Mesna

Interventions

Mesna DRUG

12 mg/kg IV infusion over five minutes at the beginning of dialysis thrice weekly.

Also known as: Mesnex, Uromitexan

Mesna

Saline OTHER

Saline IV infusion over five minutes at the beginning of dialysis thrice weekly.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with end-stage renal disease who have received hemodialysis thrice weekly for at least 90 days
• Serum albumin \> 30 g/L.

You may not qualify if:

• Patients who refuse to sign a letter of informed consent
• Women who are or are trying to become pregnant or are breast-feeding.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Mesna; Sodium Chloride

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• David J Freeman, MSc, PhD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

• Andrew A House, MD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: September 3, 2007
• Study Start: March 1, 2007
• Study Completion: June 1, 2007
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

CA (1)