NCT00421785

Brief Summary

The aim of our study is to investigate the effect of N-acetylcysteine on peritoneal small solute clearance and removal of salt and water in prevalent CAPD patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

January 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

July 9, 2007

Status Verified

July 1, 2007

First QC Date

January 11, 2007

Last Update Submit

July 6, 2007

Conditions

ESRDPeritoneal Dialysis

Keywords

N-acetylcysteinePeritoneal DialysisADMA

Outcome Measures

Primary Outcomes (3)

  • dualysis adequacy

    1 month

  • Change in peritoneal small solute transport, measured as adequacy of urea removal - Kt/V.

  • Change in peritoneal ultrafiltration rate on PET test.

Secondary Outcomes (2)

  • Change in residual kidney function

  • Change in Body Weight and Blood Pressure.

Interventions

Oral N-Acetylcysteine 1200 mg x 2/day for 4 weeks.DRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The study will include 20 patients with ESRD, treated with chronic peritoneal dialysis .

You may not qualify if:

  • Recently started treated with chronic dialysis: less than 3 months.
  • Survived recent peritonitis in the last 3 months.
  • Patients with acute renal failure
  • Currently treated with antioxidants ( NAC, vitamin E ets.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dialyss unit

Ẕerifin, 70300, Israel

RECRUITING

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

  • Leonid S Feldman, MD

    Assaf Harofeh MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonid S Feldman, MD

CONTACT

+972-8-9779383leonidf@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 12, 2007

Study Start

February 1, 2007

Study Completion

January 1, 2008

Last Updated

July 9, 2007

Record last verified: 2007-07

Locations

IL(1)