NCT00440869

Brief Summary

The purposes of the study are to determine whether oxidative stress causes the muscle of dialysis patients to tire more quickly than muscle of people without kidney disease and to determine whether treatment with N-acetylcysteine, an antioxidant, can improve muscle endurance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 3, 2010

Status Verified

March 1, 2010

Enrollment Period

2.8 years

First QC Date

February 26, 2007

Last Update Submit

March 2, 2010

Conditions

End-Stage Renal DiseaseDialysisHemodialysis

Keywords

N-acetylcysteineoxidative stressmuscle fatigueend-stage renal diseasehemodialysis

Outcome Measures

Primary Outcomes (2)

  • change in quadriceps muscle endurance during intermittent submaximal contractions

    6 days

  • change in exercise-induced markers of oxidative stress

    8 days

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL

Active

Dietary Supplement: N-acetylcysteine

placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: placebo

Interventions

N-acetylcysteineDIETARY_SUPPLEMENT

600 mg po bid

N-acetylcysteine
placeboDIETARY_SUPPLEMENT

bid oral dosing

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age greater than 18 years
  • undergoing hemodialysis for 3 months or more or healthy control without kidney disease

You may not qualify if:

  • inability to give informed consent
  • diagnosis of diabetes mellitus
  • musculoskeletal contraindication to exercise
  • infection requiring intravenous antibiotics within 2 months
  • hospitalization within 2 months
  • ingestion of antioxidant supplements within one month
  • requirement for systemic anticoagulation
  • estimated GFR \<60 ml/min/1.73 m2 for healthy controls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (2)

  • Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

    PMID: 37916745DERIVED

  • Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

    PMID: 37651553DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Kirsten L Johansen, MD

    University of California, San Francisco, San Francisco VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

February 26, 2007

First Posted

February 27, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 3, 2010

Record last verified: 2010-03

Locations

US(1)